Title: QC Senior Technical Consultant
Location: Boston, MA (REMOTE)
Job Type: 12-month contract w/extension possibilities
The QC Senior Technical Consultant will support, and may lead lab activities for the interpretation and implementation of laboratory requirements in response to changing compendial guidelines and/or regulatory requirements. The candidate's ability to assess changes to Reg guidelines and impact testing requirements to maintain QC lab compliance is a must. The technical consultant will help support the QC managers in the areas of Lab Compliance, Laboratory management, equipment management and training. Candidate will assist to ensure compliance during a time of change and site decommissioning activities throughout 2021.
Responsibilities will include, but are not limited to, the following:
- Represent Quality Control by participating in and leading cross-functional meetings with AS&T, Quality Assurance, Manufacturing, Validation, Regulatory, and others.
- Assist in the technical review of test methods and procedures for testing and release of nano-liposomal drug products, APIs, and raw materials using HPLC, GC, KF, TOC, and ELSD.
- Assist in the review and response to the relevant regulatory agency filings as per required
- Review relevant CMC documents in support of regulatory filings (ie: IND, NDA and ANDA) and ensure compliance and/or determine impact to Laboratory activities.
- Author and review SOPs, Lab investigations, and Change controls.
- Assist in timely completion of CAPA, Action Items, Investigations, and decommissioning activities.
- S. or M.S. in applicable science field; chemistry preferred.
- Knowledge and understanding of various analytical methods required.
- Analytical development experience and knowledge desired (e.g., HPLC, GC, CAD, ELSD, DLS, and wet chemistry techniques)
- Proven track record in Quality systems and GMP & GLP compliance.
- Working knowledge of cGMP guidelines from FDA, EMA, EDQM, and ICH.
- Familiarity with basic and/or common compendial methods from USP, EP, and other compendia.
- 10+ years of experience in Quality Control / GMP laboratories is required.
- Ability to work with minimal supervision as well as in a team environment
- Strong organizational and presentation skills
- Strong relationship,teambuilding, customer-focused orientation coupled with the ability to deliver results and meet or exceed agreed-upon objectives andtimeframes:
- Personal flexibility and a proactive orientation;
- Ability to handle multiple priorities.
- Ability to work under time and resource constraints.
- Commitment to excellence and high standards.
- Established background in technical QC and GMP experience.
- Solid background in investigations, determining root cause for OOS and invalid results.
Communication & Interpersonal Skills
- Well-developed interpersonal, verbal and written communication skills.
- Mature organizational skills
- Demonstrated capabilities for delivering multiple products and services in a team-based organization through influence and leadership.
Essential Functions - Physical Position Requirements: Machines and/or Equipment Used
- PC literacy required; MSOffice skills (Outlook, Word, Excel, PowerPoint)
- Lab systems such as Waters Empower and Agilent HPLC systems.
- Regularly required to operate standard office equipment (personal computer, photocopy machine, fax machine, etc.)
- Ability to work on a computer up to 7 hours a day.
- Regularly required to sit for long periods of time, and occasionally stand and walk.
- Regularly required to use hands to operate computer and other office equipment.
- Close vision required for computer usage.
- Occasionally required to stoop, kneel, climb and lift up to 25 pounds.