The QA Specialist is a position which is responsible for assisting Quality management with the day-to-day operations of the various Quality Assurance functions at a critical vendor’s manufacturing site. This includes being the liaison between the vendor and our team, providing onsite quality support to the vendor’s team, review of change controls, procedures and other documents related to our products, and the disposition of materials in accordance with cGMP’s and Standard Operating Procedures.
Responsibilities
- Manage the document creation or revision process within project timelines using electronic systems. Documents may include procedures, specifications, master batch records and forms
- Responsible for the issuance of Working Batch Records
- Independently review production batch records for accuracy, integrity and completion
- Independently disposition materials, including product and raw materials
- Prepare and/or approve Certificate of Analysis and Certificate of Conformance.
- Review and approve deviations, non-conformances and other information as deemed necessary. Investigate trends, prepare reports and notify management of issues needing further review.
- Participate in and/or support Quality audits (internal and external) with the support of Quality team
- Maintain open communication between our team and vendor
- Maintaining training records and ensuring appropriate training is scheduled
- Other duties as assigned
Minimum Job Qualifications
Education
- Bachelor’s degree is required (scientific field is preferred)
Experience
- 3-5 years of relevant work experience in Quality Assurance, Quality Control, or pharmaceutical manufacturing is required
- Prior work experience with cGMP batch release process
Knowledge/Skills/Abilities
- Must have a thorough understanding of cGMP’s and demonstrated working under/with GMP regulations for the pharmaceutical industry
- Must have a thorough understanding of quality systems such as Enzyme, Trackwise, Veeva (or similar)
- Ability to organize and write technical reports
- Ability to self-direct and be resilient and focused under pressure
- Good project management skills
- Strong computer skills and knowledge of word processing software and spreadsheet software. Must have solid working knowledge of MS Office suite (Word, Excel, PowerPoint, Access and Outlook).
- Competent in leading meetings, investigations and projects
- Act with professionalism and treat others with respect and consideration regardless of their status or position
