This is an on-site position in College Station, TX.
- The Quality Assurance (QA) Analyst I, under direct supervision, will be responsible for assisting with the review and / or approval of basic and technical documentation;
- Drafting and reviewing of internal Quality policies and procedures; Assisting with product related activities; Assisting with Quality audit functions;
Identifying process and Quality System improvements.
Reports to Supervisor / Manager, QA
Work Location College Station, TX
Primary Responsibilities :
- Assist with review of basic documentation to include, but not limited to : Standard Operating Procedures, Corrective Action / Preventive Action Plans, and Data Reports
- Assist with review of internal quality policies, procedures, and reports.
- Assist with inspection of final product containers and review and / or approval of executed process records and data.
- Assist in Quality audits to include, but not limited to : audit of lab notebooks, audit of equipment logbooks, and review of vendor, supplier, contract laboratory audit questionnaires
- Notify Senior Management of potential quality or regulatory issues that may affect product quality or regulatory compliance.
- All other duties as needed.
Qualifications :
- Bachelor’s degree in a related science concentration with some experience in Quality Assurance supporting pharmaceutical or biotechnology products; OR
- Associate’s degree in a related science concentration with 2+ years of experience in Quality Assurance supporting pharmaceutical or biotechnology products; OR
- High School Diploma or GED with 4+ years of experience in Quality Assurance supporting pharmaceutical or biotechnology products required.
- ASQ Certification preferred.
- Knowledge of GMP / GLP regulations 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 Office.
- All candidates will have a working knowledge of cGMP regulations to produce drug, biologics, or vaccine products.
- Role model for company core values of trust, delighting our customers, Gemba, and Genki.
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