Senior QA Analyst - Night Shift (On-site in College Station, TX)

? **This position does support our site in College Station, TX and will require relocation to the area.

The Senior Quality Assurance (QA) Analyst, under minimal direction, will be responsible for review and/or approval of basic and technical documentation, drafting and reviewing of internal Quality policies and procedures, performing product related activities, performing Quality audit functions, performing product release activities, identifying process and Quality System improvements, and acting as a QA liaison internally and externally. They will also provide daily guidance, work prioritization and support to other departments, such as manufacturing or QC, in absence of or in conjunction with their manager.

Reports to Director/Senior Manager/Supervisor, Quality Assurance

Work Location College Station, TX

Primary Responsibilities: ? Review and/or approve basic and technical documentation with minimal supervisory oversight to include, but not limited to:

• Standard Operating Procedures

• Batch Production Records (completed and approval)

• Commissioning, qualification and validation protocols and reports

• Deviation Reports

• Corrective Action/Preventive Action Plans

• Technical data review and approval

• QC data review and approval

• Drug Substance/Product Reports

• Trending QA data
? Draft and review internal Quality policies, procedures and reports.? Perform inspection of final product containers and review and/or approval of executed process records and data.? Perform Quality audit functions to include, but not limited to:

• Audit of lab notebooks

• Audit of equipment logbooks

• Review of vendor, supplier, contract laboratory audit questionnaires

• Lead vendor, supplier, contract laboratory and client audits
? Identify process and Quality System improvement opportunities.? Provide daily guidance for the compliance of the QA department to national and international standards and regulations.? Support Regulatory, client, and internal audits.? Act as QA liaison to internal Departments and external Client Quality Groups and Vendor/Contract Laboratory Quality Groups.? Promptly notify Senior Management of potential quality or regulatory issues that may affect product quality or regulatory compliance.? Assist with technical oversight/training for the QA team.? Assist with compliance related functions.? Ensure priority task coverage.? Escalate any issues as identified to Quality Management and/or departmental Management as needed.? All other duties as assigned.

Qualifications: ? Master?s Degree and 3+ years of Pharmaceutical or other regulated Industry experience. ? Bachelor?s Degree and 5+ years of Pharmaceutical or other regulated Industry experience. ? Associate?s degree and 7+ years of Pharmaceutical or other regulated Industry experience. ? Certified Quality Auditor 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 multitask and easily prioritize your work. ? Ability to work independently with little supervision. ? Proficient in Microsoft Excel, Word and PowerPoint. ? All candidates must 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.