QA Analytical Specialist

QA Analytical Specialist 
Employment Type: Contract
Interview Process: Initial 30-minute virtual screening followed by two consecutive 30-minute virtual panel interviews
Make an Impact on Product Quality, Compliance, and Patient Safety
We are seeking a detail-oriented QA Analytical Specialist to support quality assurance oversight of analytical and microbiology testing activities within a regulated pharmaceutical and biotechnology environment. This role plays a critical part in ensuring that drug substance and drug product testing meets global GMP requirements and supports the release of materials for clinical and commercial distribution.

The ideal candidate will bring experience in Quality Assurance, analytical testing, laboratory investigations, GMP compliance, batch record review, and quality systems management. You will work cross-functionally with Quality Control, Manufacturing, and Quality Assurance teams to drive compliance, resolve quality issues, and support continuous improvement initiatives.
Key Responsibilities Quality Oversight & Analytical Review

• Review and approve QC testing records and associated Out-of-Specification (OOS) investigations.
• Ensure analytical testing activities are performed according to approved methods, regulatory filings, and quality standards.
• Provide QA support and technical expertise for issues arising from analytical and microbiological testing.
• Oversee internal and external testing activities to ensure compliance with global GMP regulations.

Product & Material Release Support

• Review and approve analytical and microbiological testing results for:
  • Raw materials and starting materials
  • Buffer solutions
  • Bulk drug substance
  • Drug product intended for clinical and commercial distribution
• Evaluate test results against approved specifications and determine product or material disposition.
• Prepare and review Certificates of Analysis (CoA) for clinical and commercial products.
• Assess laboratory data trends and identify potential quality or process concerns.

Quality Systems & Investigations

• Participate in troubleshooting laboratory investigations, deviations, and testing-related issues.
• Ensure quality records are completed and closed prior to material or lot release, including:
  • Deviations
  • Investigations
  • Change controls
  • Corrective and Preventive Actions (CAPAs)
• Support product disposition decisions through quality risk assessments and analytical evaluations.

Documentation & Compliance

• Review executed batch records for bulk drug substance, drug product, and packaged materials.
• Author, revise, review, and approve Standard Operating Procedures (SOPs).
• Inspect and release production materials against approved specifications.
• Review supplier and vendor certificates for completeness and compliance.
• Maintain accurate documentation in accordance with GMP and company quality requirements.

Audits & Regulatory Support

• Assist with internal quality audits and contract testing laboratory assessments.
• Support regulatory inspections and provide documentation as required.
• Collaborate with QA, QC, and Manufacturing leadership to improve compliance and operational effectiveness.

Required Qualifications Education

• Bachelor's degree in:
  • Biology
  • Chemistry
  • Engineering
  • Or a related scientific discipline

Experience

• 2-5 years of experience in the pharmaceutical, biotechnology, or life sciences industry.
• 1-2+ years of analytical laboratory experience preferred.
• Proven experience working within a GMP-regulated environment.
• Experience reviewing analytical data and supporting quality systems processes.

Technical Knowledge

• Understanding of analytical testing methodologies and/or analytical development activities.
• Familiarity with laboratory equipment and laboratory operations.
• Working knowledge of:
  • Change Control
  • Deviations
  • Investigations
  • CAPA programs
  • Product release processes
• Strong understanding of GMP regulations and industry standards, including:
  • FDA regulations
  • USP guidelines
  • European Pharmacopoeia (EP)
  • ICH guidance

Professional Skills

• Strong analytical thinking and problem-solving abilities.
• Excellent technical writing skills, particularly for investigation reports and quality documentation.
• Strong verbal and written communication skills.
• Ability to collaborate effectively with cross-functional teams and stakeholders.
• High attention to detail and commitment to quality and compliance.

Why Join This Opportunity?
This role offers the opportunity to play a key role in ensuring product quality, regulatory compliance, and patient safety. You'll work closely with Quality, Manufacturing, and Laboratory teams while gaining exposure to analytical testing oversight, quality systems, investigations, and product release operations in a dynamic pharmaceutical environment.

Keywords: QA Analytical Specialist, Quality Assurance Specialist, GMP Compliance, OOS Investigations, CAPA, Change Control, Pharmaceutical Quality Assurance, Biotechnology Quality, Analytical Testing, Batch Record Review, Product Release, Quality Systems, Laboratory Operations, QC Testing, Drug Substance, Drug Product, Regulatory Compliance, Life Sciences Jobs, Contract QA Jobs.