QA Analyst II - All Shifts (On-Site in College Station, TX)

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.