Quality

Quality

Quality operations is an essential function of the life sciences industry. Drug manufacturers must thoroughly test materials, processes, equipment, techniques, environments and personnel in order to ensure their final products are consistent, safe, effective and predictable. Even when a drug does make it to market, there is no guarantee it will succeed.

From January 2013 to October 2018, approximately 8,000 medications were recalledby pharmaceutical companies globally, following concerns over quality. Whileevery year, €4.5bn is wasted due to expired, lost or uncaptured medical device charge costs. To avoid operational inefficiencies, information needs to be kept up-to-date and products captured at point of use to enable intelligent healthcare and purchasing decisions.

Companies are all too aware of the risk, according to research,67% of executivesconsider cost of quality essential to competitive success. Quality issues can be the result of a slip up somewhere along a complex supply chain or during the design, testing and manufacturing process. A single error can have severe consequences not just for patients, but shareholders too - one major quality event can mean a ten percent drop in a manufacturer’s share price, accordingto MGI.

One of the most recognised groups representing quality professionals in Germany is theGerman Quality Management Association(GQMA). The organisation is the largest German association for quality management in the chemical and pharmaceutical industry, and is led by itsPresident, Steffen König. Their aims include the promotion of scientific information and opinion exchange as well as the promotion of purpose-specific education and training.

One of the key areas GQMA must educate its members on is Industry 4.0. Ushering in a new era of interdisciplinary research and practice that focuses heavily on interconnectivity, automation, machine learning, and real-time data, Industry 4.0 has the potential to revolutionise the quality process.According to a report by Pharma Manufacturing, the first real-life cases of implementing such innovations have delivered a 50% reduction in overall quality control costs. Digitisation and automation will also ensure better quality and compliance by reducing manual errors and variability, as well as allowing faster and effective resolution of problems. Test cases have demonstrated incidents with over 90% faster closure times.

InDeloitte’s Global Life Sciences Sector Outlook,research points to “an evolving regulatory and risk environment” heightening the need for skilled life sciences professionals. As the life sciences industry continues to grow, so too will the medical device and pharmaceutical quality assurance sectors.

EPM Scientific is a global specialist recruitment company working exclusively in the Life Sciences industry. Our expert consultants place the best talent in the quality industry in Germany and across Europe.


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Quality Jobs

Validation Engineer Contractor

My biopharmaceutical client supports aspects of new drug development with the goal of improving quality of life. They are in search of a new addition who will join the validation team to lead engineering activities for internally manufactured products. Where: Hybrid onsite in Minnesota (3 days onsite) Details: W2 Contract with EPM Scientific, short term contract role (opportunity for extension or conversion Additional: Benefits are included during the duration of the contract (health, dental, and vision) Validation Engineer Contractor 5-7 years of medical device or Biotech experience Skilled with statistical analysis of validation data using Minitab Experience with CAPA/NCR/SCAR/complaint investigations and/or reports Prior experience with developing test method validation (TMV) protocols & automated reports B.A. in Mechanical or Biomedical Engineering Background in sterile pharmaceutical products ASQ certification is a plus Let me know if this role is of interest to you, please send your most recent resume & I will give you a call!

Vision, Medical, Dental & 401K option
Minnetonka
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Quality Control Manager- Microbiology

Quality Control Manager- Microbiology Location: Rhode, Island Working Situation: Onsite Level: Mid-Senior Level Manager Our client, a Mid-Sized, Pharmaceutical Company, is leading partner for CDMO turnkey formulation, manufacturing and packaging solutions in the OTC, cosmetic and homeopathic markets. With full cGMP compliance, they provide seamless offerings and end-to-end integration at every stage of your product's development, from discovery and manufacturing through launch and commercialization. The Quality Control Manager- Microbiology will: plays a critical part in maintaining the quality and safety of pharmaceutical products by monitoring utilities, conducting essential testing, ensuring compliance with industry standards, and providing support to the laboratory team. Knowledge of regulatory requirements and the ability to interpret and apply them is vital for this position. The Quality Control Manager- Microbiology will: Execute and Review Routine Microbial Laboratory Work Ensures the proper labeling, handling, and storage of all chemical and biohazard materials in the laboratory. Manages the labeling and disposal of hazardous waste in satellite areas, adhering to safety requirements and protocols. Ensures that method verifications, qualification protocols, and investigations are conducted appropriately. This includes overseeing the validation of testing methods to ensure accuracy and reliability. Utilizes technical discretion to ensure that experiments and tests are conducted accurately and in alignment with program goals. Qualified trainer for the Quality Microbiology team and performs training for staff on programs as needed. The Quality Control Manager- Microbiology has the following qualifications: Bachelor of Science degree in a scientific discipline with a minimum of 5 years of technical experience 3 years of managerial experience. Must have knowledge of GMPs and biotechnology-derived product regulations and be able to react to change productively and handle other essential tasks as assigned. experience in managing deviations, CAPA's, and environmental monitoring experience in managing the sample preparation and diagnostic areas of microbiology, USP, AET and media departments Company Benefits: Generous Benefits Package 401K match PTO Training and development programs

Negotiable
Rhode Island
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Quality Systems Engineer, II

Quality Systems Engineer II Position Summary: The QS Engineer II will assist in ensuring that quality systems are in place and cGMP compliance is maintained. Work and decisions will be based on a collaborative culture with individuals throughout the facility. ESSENTIAL FUNCTIONS: Draft and revise procedures as required to ensure that documentation and operations meet established requirements of regulations, cGMPs, and internal SOPs and company policies. Apply and maintain quality standards and procedures for quality systems. Review executed cGMP documents and participate in or lead the implementation of systems, processing and storage of cGMP information. Monitor the status of assigned quality system(s), providing periodic reports and status updates on the overall performance of the quality system(s). Operate in an environment of strict timelines. Oversee and or support the process of change control approval from evaluation of an initial proposal, through approval, implementation, closure and effectiveness review. Assist with scheduling and driving activities of the risk management program with respect to scheduling meetings, developing quality documentation and data management. Help ensure that manufacturing sites comply with the requirements of the risk management program and complete assessments and reports in a timely manner according to regulations, procedures and policies. Participate in the risk assessment process as it relates to assisting with training of personnel, categorizing risk and assigning report numbers. Provide clear and concise reports of risk management activities/assignments throughout the site and provide key metrics that monitor compliance for the risk management program. QUALIFICATIONS, EDUCATION AND EXPERIENCE: Bachelor's degree or equivalent with 2+ years of relevant Quality/Compliance experience in a cGMP biotech or pharmaceutical regulated industry. Experience performing work that consistently requires independent decision making and the exercise of independent judgment and discretion in a cGMP environment. Experience writing and reviewing technical cGMP documents A strong understanding of Medical Device and Biologics FDA regulations. Strong working knowledge of Trackwise or other quality management systems. Proven Risk Management/FMEA experience/knowledge. Good project management skills and working knowledge of statistical techniques. Experience serving as a Subject Matter Expert (SME) in regulatory inspections.

Negotiable
Cambridge
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Analytical Quality Assurance Associate

Are you interested in embarking on an extraordinary opportunity with a leading global pharmaceutical company? This organization is dedicated to an expansive range of cutting-edge medications that revolutionize healthcare on a global scale. Joining this team means playing a pivotal role in pioneering research, shaping the future of medicine, and positively impacting lives worldwide. If you are interested in working alongside industry visionaries, driving innovation, and being a part of a profound transformation in the pharmaceutical landscape, apply below! Responsibilities Validate and calibrate analytical equipment for compliance and review and ensure adherence of analytical documents to standards Confirm validation processes align with protocols and utilize analytical laboratory software effectively Develop and align standard procedures with industry guidelines Identify system gaps and propose improvements and conduct and review laboratory investigations Uphold data integrity and cGMP practices strictly Perform additional assigned duties Qualifications Bachelor's degree in Chemistry or related life sciences field required 2+ years of experience in analytical QA or QC preferred 2+ years of experience in the pharmaceutical industry preferred Experience working with inhalation products is a plus Benefits Competitive benefits including 401k, medical, health insurance, etc. Sponsorship and relocation package available Salary: $70,000 - $90,000 per year

US$70000 - US$90000 per year
Hauppauge
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Validation Engineer

Validation Engineer Location: Shreveport, LA Working Situation: Onsite Position Overview: Assist in fostering collaboration with Quality, Manufacturing, Packaging, Technical Services, and Engineering teams to ensure effective quality oversight of new equipment, systems, and process validation. Additionally, this role will evaluate modifications to current equipment and processes within the pharmaceutical manufacturing DRL Shreveport Plant. Responsibilities: Assures that systems and processes, in the following areas, are defined and executed in compliance with cGMP and applicable company policy. Develop and execute protocols for equipment validation, cleaning, equipment and process validation. Participate in cross-functional teams to provide technical support for new product development and launch. Knowledge of cGMP environments to review of GMP documents including but not limited to Change Control documents, Master Batch Records, SOPs, APRs, specifications, or Laboratory Data. Qualifications: Bachelor's degree in a Science, Engineering or related field with 3-5 years of pharmaceutical industry experience. Experience necessary with pharmaceutical process validation, cleaning validation, equipment, utilities, and computer system qualification processes. Strong technical writing skills. Ability to work independently and as part of a team. Excellent communication skills.

Negotiable
Shreveport
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Senior Quality Assurance Associate

Salary: Negotiable Location: Ireland (mostly remote) My client (a boutique pharmaceutical company) is looking for a Senior Quality Assurance professional to join their team. The role will be remote based in Ireland; some European travel may be required. Working across the global business as part of a high-performing team there is an expectation of out-of-hours flexibility to deliver on projects. The Senior Quality Assurance Associate will interact closely with the pharmacovigilance and regulatory departments and all GMP/GDP service providers to ensure the required post-approval compliance level is achieved and maintained. The ideal candidate should have: Experience with GMP and GDP Operational Quality Systems for Commercial Drug Product Distribution Supply Chain Operations experience Relevant experience in a pharmaceutical or other life science organisation Experience in utilising of quality System processes (such as, Audit, Deviations, CAPA, Change Control) Good experience of articulating and implementing SOPs & quality documents Ability to clearly and concisely communicate technical information Studious, active mind, willing to acquire knowledge Ability to research, analyse and report independently across a breadth of topics Excellent administrative and people skills Ability to work under pressure Flexibility to adjust course when required Ability to work autonomously and prioritise workflow Flexible approach to working hours where needed Experience using and/or implementing an electronic quality management system is desirable Auditing experience is desirable Regular Working hours are Monday to Friday from 8.30am to 5.30pm. Work is in a hybrid role, with some work from the Dublin office. Regular office hours contact expected longer-term. Due to the seniority and global nature of the role, regular out of hours work is expected What's on Offer: A competitive salary with benefits. The chance to contribute and be part of a team whose work directly benefits healthcare and strives to improve people's lives. A real hands-on opportunity to gain a high degree of commercial exposure. The chance to work alongside world-leading scientific experts. Working with highly-talented and dedicated colleagues in a fast-growing company that combines a focus on cutting-edge science with commercial delivery. If interested apply directly or contact me via: 📧: 📞:+44 20 7019 41

Negotiable
Republic of Ireland
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Quality Assurance Manager

Quality Assurance Manager Location: Tampa, Florida Working Situation: Onsite Level: Mid-Senior level Our client, a leading nutraceuticals company specializing in silver dietary supplements and homeopathic remedy manufacture is looking to add a Quality Assurance Manager to their vastly growing team. Quality Assurance Manager The Quality Assurance Manager will play a critical role responsible for overseeing the company's Quality Assurance activities, ensuring compliance with state and federal regulations. Assisting in day-to-day oversight of the QA department. The Quality Assurance Manager will play a key role in shaping the future of medicine by assisting with all aspects of Quality Operations. The Quality Assurance Manager will: Oversee quality operations and manage a QA department of 3 direct reports Enforce compliance with GMP in the Operations department Conduct annual internal audits Responsible for document control and quality improvements The Quality Assurance Manager has the following qualifications: 4 years of people management experience (required). Experienced in hosting Federal and State inspections Bachelor's Degree in relevant fields with 7+ years of pharmaceutical industry experience. Company Benefits: A competitive salary PTO, company health care plan, medical, dental, and vision insurance Short and long-term disability insurance, life insurance policy 401k opportunities for continuing education.

Negotiable
Tampa
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QA Specialist/ Manager

A small Medical Device organization specializing in creating silicone tubing is looking to add a Quality Specialist/Quality Manager to the team (title is negotiable based on experience). Ideally, the team is looking for someone open to growing within the organization for years to come, as they will play a crucial role in the company's trajectory moving forward. This is an on-site position in Paso Robles, CA. Candidates must be local/willing to relocate. Key Responsibilities: - Develop and implement quality management systems in accordance with ISO 13485 and FDA med device regulations. - Ensure compliance with all regulatory requirements, industry standards, and customer specifications. - Manage the QA team and ensure timely completion of all quality-related tasks and projects. - Oversee all aspects of the quality assurance and quality control programs. - Develop and implement quality control procedures and ensure product quality and consistency. - Develop and implement corrective and preventive action plans to address quality issues. - Work with cross-functional teams to identify and resolve quality issues. - Perform internal audits and ensure compliance with all quality standards. - Provide training and guidance to employees on quality-related matters. Skills: - Strong knowledge of ISO 13485 and FDA med device regulations. - Strong problem-solving and analytical skills. - Excellent leadership and people management skills. - Excellent communication and interpersonal skills. - Ability to work well in a team environment. - Strong attention to detail. - Strong organizational and time management skills.

US$85000 - US$140000 per annum
Paso Robles
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Quality Assurance Manager

Experience: Over 5 years of quality management experience within the medical device, consumer healthcare, or pharmaceutical industries. Expertise in ISO 13485 or GMP Pharma and ISO 14971, with a preference for ISO 22000 experience. Extensive track record in ensuring compliance with the Medical Device Directive (MDD) and navigating the complexities of the Medical Device Regulation (MDR). Skilled in managing ISO 13485 or GMP Pharma Quality Management Systems (QMS) and overseeing Quality events such as Complaints, Non-Conformities (NCs), Change Controls, and Corrective and Preventive Actions (CAPAs). Demonstrated enthusiasm, competence, and IT proficiency in utilising SAAS-based Electronic Quality Management Systems (eQMS) for efficient quality management. In-depth understanding of manufacturing processes for Medical Devices or Pharmaceuticals. Demonstrated expertise in building strong relationships and effectively engaging with C-level executives at external (manufacturing) sites (CMOs). Audit and/or consulting experience, particularly related to MDR certification. Education/Certifications/Qualifications: Possession of a Master's degree in Pharmacy or Biomedical Sciences, or equivalent. Relevant certifications and qualifications in quality management and regulatory affairs within the medical device industry. Skills: Proactive and hands-on approach. Effective communication and influential skills across all organisational levels. Proficiency in both written and spoken English. Strong analytical and problem-solving capabilities. Expertise in process management and enhancement. Comprehensive knowledge of quality assurance. Excellent verbal and non-verbal communication skills, including the ability to train others. Proven capability in relationship management. Team leadership skills. Other Requirements: Candidates must be located in the Netherlands or have strong connections there, with a valid work permit. Willingness to work primarily on-site, preferably for four days a week in the office. Possession of a valid European driver's license. Willingness to travel to CMOs within the Netherlands and across Europe as needed (5-10%).

Negotiable
Amsterdam
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Quality Assurance Specialist

**Hybrid Role in Columbus. Ohio** Job opportunity with a top Biotech/Pharmaceutical company that is looking for a Quality Assurance Professional to join their team on a 6-month contract. Qualifications: BS/BA Degree in a scientific discipline. Advanced degree preferred. 5+ years experience in a related regulated industry 2+ years in a GLP or clinical laboratory Quality Assurance or Quality Control role. Technical knowledge of nonclinical GLP studies and bioanalytical and clinical test method validations Job Description/Skills: Conduct protocol and protocol amendment reviews, in-study inspections, and data and report audits for nonclinical, method validation, and clinical sample testing studies for compliance to applicable regulations (GLP, GCP), methods, and SOPs. Perform facility inspections to assure management that the facilities, equipment, personnel, methods, practices, records, and controls are in conformance with GLP regulations. Review other controlled documents, e.g., Test Methods, and select SOPs and Policies, as requested by Testing Facility Management. Review of quality events associated with the site GLP activities including deviations, investigations, CAPAs, quality metrics. Support internal, Sponsor or regulatory inspection activities at the OH site. Benefits/Perks: 401k Health Insurance Please apply here directly if interested but If you are genuinely not interested, is there someone you can recommend?

Negotiable
Columbus
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Sr. Design Quality Engineer

Come join our Class III Medical Device client in northern MA as a Senior Design Quality Engineer to support NPI and sustaining projects! Responsibilities: Oversee and act as SME for entire design control process, ensuring projects meet customer expectations and regulatory requirements. Contribute to design and manufacturing engineering project DHF deliverable review DHF files and provide guidance on FDA compliance Review and approve design control-related Change Notices (CNs) within QMS Represent design quality functions for the review and approval of designated design outputs. Requirements: Experience in the Medical Device industry and design controls Knowledge of 21 CFR 820, ISO 13485, ISO 14971 Experience with process validation, IQ/OQ/PQ, Gage R&R

Negotiable
Massachusetts
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QC Engineer- Continuous Improvement

A leading medical device company, is seeking an experienced Quality Control Engineer to join their team. The successful candidate will be responsible for driving continuous improvement and developing quality metrics to ensure the highest standards of quality output. Key Responsibilities: - Supporting Quality Control in containment, investigation and resolution of non-conformances. - Maintaining nonconforming database and supporting equipment calibration. - Leading lean thinking, team involvement and problem solving to improve quality output. - Evaluating and analyzing current quality metrics and feedback to target and reduce quality defects. - Collecting production data, analyzing outputs, and determining corrective courses of action to promote quality and efficiency. - Working with management to drive continuous improvement and assist in the development of Quality Metrics. - Developing, implementing, and managing Quality Control/Quality System process improvements. Key Qualifications: - BS in mechanical engineering discipline; plus, 1-2 years' experience in an FDA/ISO regulated Medical Device industry - 5+ years of experience in a Quality Engineering role - CAPA and MRB experience - Six Sigma, Lean Concepts, 8D Problem Solving experience - SPC, basic statistical tests experience - Mechanical drawing, GD&T experience - DFMEA and PFMEA experience

Negotiable
Andover
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