The Quality Assurance (QA) Analyst II, under general direction, will be responsible for review and/or approval of basic and technical documentation; Drafting and reviewing of internal Quality policies and procedures; Assisting in and performing product related activities; Assisting in and performing Quality audit functions; Identifying process and Quality System improvements; Acting as a QA liaison internally.
Reports to Supervisor/Manager, QA
Work Location College Station, TX
Primary Responsibilities:
- Review basic and technical documentation to include, but not limited to: Standard Operating Procedures, Analytical Methods, Disposition certificates, Batch Production Records, Corrective Action/Preventive Action Plans, QC Data review , Technical Data Review, Drug Substance/Product Reports.
- Review internal Quality policies, procedures and reports.
- Assist in and perform Quality audit functions to include, but not limited to: Audit of lab notebooks, and audit of equipment logbooks
- Act as a QA liaison to internal Departments and Vendor/Contract Laboratory Quality Groups.
- Notify Supervisor of potential quality or regulatory issues that may affect product quality or regulatory compliance.
- All other duties as needed.
Qualifications:
- Master’s degree in a related science concentration with 1+ year of experience of cGMP supporting pharmaceutical or biotechnology products; OR
- Bachelor’s degree in a related science concentration with 2+ years of experience of cGMP supporting pharmaceutical or biotechnology products; OR
- Associate’s degree in a related science concentration with 4+ years of experience in a regulated industry, including 2+ years of experience of cGMP supporting pharmaceutical or biotechnology products; OR
- ASQ Certification preferred.
- Degree in Biology or Chemistry preferred.
- Excellent written and oral communication skills.
- Excellent organizational, analytical, data review and report writing skills.
- Ability to set personal performance goals and provide input to departmental objectives.
- Ability to adapt to frequent and rapid changes in the work environment and allocate, adjust and optimize time accordingly.
- Ability to work independently and establish work priorities to meet targets and timelines.
- Proficient in Microsoft Excel, Word and PowerPoint.
- All candidates will have a working knowledge of cGMP regulations for the production of drug, biologics or vaccine products.
- Role model for company core values of trust, delighting our customers, Gemba, and Genki.
