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

FUJIFILM Diosynth Biotechnologies; United States; On-site; USD 60,000 - 100,000; Full time

Job summary

An established industry player is seeking a Senior QA Analyst to join their team in College Station, TX. This role involves ensuring compliance with quality standards in a dynamic environment, where you will review technical documentation, perform audits, and identify process improvements. The ideal candidate will have a strong background in quality assurance within the pharmaceutical or regulated industries, alongside excellent communication and organizational skills. This position offers an exciting opportunity to contribute to high-quality standards and support product excellence in a collaborative team setting.

Qualifications

• 3+ years in Pharmaceutical or regulated Industry required.
• Certified Quality Auditor preferred; knowledge of cGMP regulations essential.

Responsibilities

• Review and approve technical documentation and policies.
• Perform Quality audits and identify improvement opportunities.
• Act as QA liaison to internal and external stakeholders.

Skills

Excellent written and oral communication skills

Organizational skills

Analytical skills

Data review skills

Report writing skills

Ability to multitask

Ability to work independently

Education

Master’s Degree in relevant field

Bachelor’s Degree in relevant field

Associate’s Degree in relevant field

Tools

Microsoft Excel

Microsoft Word

Microsoft PowerPoint

Job description

Senior QA Analyst - Day 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.

Seniority Level

Associate

Employment Type

Full-time

Job Function

Quality Assurance and Science

Industries

Biotechnology Research and Pharmaceutical Manufacturing