QA Specialist III, QA Validation (On-site in College Station, TX)

FUJIFILM Biotechnologies; United States; On-site; USD 70,000 - 95,000; Full time

Job summary

A leading company in the biotechnology industry is seeking a QA Specialist III for their College Station site. This role will oversee quality validation processes, ensuring compliance with cGMP standards and collaborating cross-functionally within the organization. Ideal candidates will possess a degree in a related field, along with substantial experience in quality assurance within the pharmaceutical sector.

Benefits

Medical insurance

Vision insurance

401(k)

Paid maternity leave

Paid paternity leave

Tuition assistance

Qualifications

• Master’s or Bachelor’s degree with relevant experience in the pharmaceutical industry.
• Experience with qualification/computer validation.
• Excellent communication and organizational skills.

Responsibilities

• Provide QA support during document review to ensure compliance with quality standards.
• Coordinate with validation and engineering to meet compliance requirements.
• Review and approve validation protocols and deviation reports.

Skills

Excellent written and oral communication skills

Excellent organizational skills

Ability to multitask and prioritize work

Understanding of cGMP regulations

Education

Master’s Degree in Pharmaceutical or other regulated industry

Bachelor’s degree in Pharmaceutical or other regulated industry

Associate’s degree in Pharmaceutical or other regulated industry

High school diploma with 8+ years of experience

Tools

Microsoft Excel

Microsoft Word

Microsoft PowerPoint

Job description

QA Specialist III, QA Validation (On-site in College Station, TX)

QA Specialist III, QA Validation (On-site in College Station, TX)

Direct message the job poster from FUJIFILM Biotechnologies

The QA Specialist III, QA Validation, will be responsible for the review and approval of commissioning/qualification/validation protocols, reports, computer automation validation protocols and final reports and discrepancies for Quality Assurance. The QA Compliance Specialist III, QA Validation, will handle all associated responsibilities in compliance with Fujifilm quality policies and site SOPs to ensure regulatory compliance.

Reports to Manager, QA Validation

Work Location College Station, TX

Primary Responsibilities:

Leadership

• Provides QA support to the validation team during document review to ensure the organization is complying with local and global quality standards, regulatory requirements, and partner commitments.
• Work collaboratively with other site functions to instill a ‘Quality Culture’ by coaching in the application of GMP Principles including the underlying rational of those principles.
• Knowledge and understanding of Computer cGMP regulations and practices pertaining to computer validation principles, manufacturing processes, quality systems, engineering design fundamentals, SOPs, regulatory agency expectations and industry trends.
• Reviews computer test automation scripts, creation, and deviation closure recommendations as required.
• Set up and maintain QA Validation Monthly Tracker.

New Business Growth

• Support client due diligence and Quality audits as well as regulatory inspections.

Compliance

• Reviews and approves master plans, pre/post approval of qualification and validation protocols, summary reports, and associated data for conformance to regulations, SOPs, specifications, and other applicable acceptance criteria.
• Reviews and approves qualification and validation deviations and discrepancies, supports investigations and corrective actions.
• Participate in design reviews and have experience in reading P&ID’s and various engineering drawings.
• Coordinate with Validation, Metrology, Facilities, Engineering, on a daily basis to ensure any GMP protocols, requirements etc. are completed in a timely manner.
• Utilize investigative techniques to determine root causes of discrepancies and proper corrective and preventative actions.
• Promptly notify Senior Management of potential quality or regulatory issues that may affect product quality or regulatory compliance.
• All other duties as assigned.

Qualifications:

• Master’s Degree with 2+ years of experience in Pharmaceutical or other regulated Industry; OR
• Bachelor’s degree with 3+ years of experience in Pharmaceutical or other regulated Industry; OR
• Associate’s degree with 5+ years of experience in Pharmaceutical or other regulated Industry; OR
• High school or equivalent with 8+ years of experience in Pharmaceutical or other regulated Industry.
• Experience with qualification/computer validation experience.
• Experience with qualification/validation of process equipment, clean utilities, automation, sterile filling, aseptic processing, facilities, HVAC, and new construction final qualification requirements of TOP’s for GMP facilities.
• Single Use and Process Validation a plus.
• 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.
• Develop staff to maximize contributions to the team and the company.
• Ability to multitask and easily prioritize 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

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Quality Assurance, Engineering, and Science

• Industries

  Biotechnology Research and Pharmaceutical Manufacturing

Referrals increase your chances of interviewing at FUJIFILM Biotechnologies by 2x

Inferred from the description for this job

Medical insurance

Vision insurance

401(k)

Paid maternity leave

Paid paternity leave

Tuition assistance

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