Summary:
A specialized pharmaceutical company located in Kentucky, USA looking for a Quality Assurance Specialist to join their team. The company is focused on developing, manufacturing and commercializing generic and innovative nasal spray medicine. The company is looking for someone who will be responsible for providing quality involvement and supervise throughout all stages of pharmaceutical development, manufacturing and testing. Candidate should also be responsible for reviewing controlled cGMP documentation and manufacturing records, performs internal and external audits & observe critical operation.
Essential Duties:
- Supports the development and maintenance of Quality Systems as appropriate.
- Leads continuous improvement objectives to assure compliance with DEA and FDA regulations.
- Advises senior management on findings and recommendations related to internal and external auditing.
- Manages the CAPA and Change Control Systems.
- Reviews, and approves cGMP documentation including procedures, batch records, validation protocols, development reports, specifications and other related documents.
- Develops and maintains metrics and trending reports for Compliance-related activities.
- Reviews and approves product complaint investigations and assists with investigations.
- Performs activities associated with various one-time or on-going projects (from participation level to project manager).
- Cooperate with other departments and external suppliers regarding quality concerns.
- Participates and/or coordinates Compliance Assessments of departments as necessary (GXP, Part 11, etc.).
- Assist with regulatory inspections and customer audits.
- Assists Manager with daily and project activities as needed.
- Other duties as assigned.
Qualifications:
- Bachelor's degree in a scientific discipline
- At least 7 years Pharmaceutical/Medical Device cGMP quality experience
- Knowledge of HPLC principles and ability to review data for accuracy and completeness
- Ability to assess problems, to identify solutions, to plan and implement necessary changes
- Experience in quality systems auditing (internal and/or external) preferred
- Experience in manufacturing aseptically filled, sterile products preferred
- Advanced knowledge of cGMP regulations and validation principles
- Ability to work well in a team-oriented environment
- Well-developed communication and technical writing skills
- Qualified to work with controlled substances
