Aptask Global Workforce (AGW) is seeking a Quality Control Investigation Writer for a position with a Global Biotechnology Company located in High Point, NC. This is a 12 month contract opportunity. The Quality Control (QC) Investigation Writer is responsible for leading, authoring, and coordinating laboratory investigations within the Quality Control department in support of GMP-regulated pharmaceutical manufacturing operations. This role serves as a subject matter expert in the investigation process and is responsible for ensuring laboratory investigations are scientifically sound, thoroughly documented, compliant with regulatory requirements, and completed within established timelines.
Responsibilities: - Lead and author Quality Control laboratory investigations related to Out-of-Specification (OOS), Out-of-Trend (OOT), Environmental Monitoring (EM) excursions, and laboratory deviations
- Collect, review, and analyze laboratory data, test methods, and supporting documentation to determine probable root cause and product impact
- Facilitate investigation meetings with laboratory personnel and cross-functional stakeholders
- Perform and document root cause analyses using established investigation tools and methodologies
- Prepare clear, concise, and comprehensive investigation reports that meet internal procedures and FDA expectations
- Develop scientifically justified impact assessments to determine potential effects on product quality and patient safety
- Author and support associated quality records including Deviations, Corrective and Preventive Actions (CAPAs), and Change Controls
- Review investigation records for completeness, technical accuracy, and regulatory compliance
- Support Quality Assurance during investigation reviews and approvals
- Participate in regulatory inspections and internal audits
Requirements: - Bachelor's degree in Chemistry, Microbiology, Biology, Biochemistry, Pharmaceutical Sciences, or a related scientific discipline
- Minimum 2 years of experience in a GMP-regulated pharmaceutical, biotechnology, or biologics environment
- Minimum 1 year of direct experience authoring and leading laboratory investigations within a Quality Control department
- Demonstrated experience writing OOS, OOT, Environmental Monitoring (EM) investigations, laboratory deviations, CAPAs, and Change Controls
- Strong working knowledge of FDA regulations, cGMP requirements, and industry guidance related to laboratory investigations
- Experience conducting scientific evaluations and root cause analyses for laboratory events
- Advanced technical writing and documentation skills
- Strong understanding of laboratory operations, analytical testing, microbiological testing, and GMP documentation practices
- Ability to critically evaluate complex laboratory data and identify scientifically defensible conclusions
- Strong knowledge of investigation methodologies, root cause analysis tools, and quality risk management principles
Desired skills: - Experience using electronic Quality Management Systems such as TrackWise
- Familiarity with FDA Guidance for Industry: Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production
Pay range: up to $36.00 per hour
Only candidates available and ready to work directly as Aptask Global Workforce (AGW) employees will be considered for this position. If you have the described qualifications and are interested in this exciting opportunity, apply today! Aptask Global Workforce (AGW) ApTask Global Workforce (AGW) is a certified Minority and Veteran workforce solutions company. AGW delivers operational, clinical, lab and professional talent with a strong focus on healthcare and life sciences. The company supports clients with reliable staffing, program expertise and a commitment to quality, speed and consistent delivery.
Benefits of working with ApTask Global Workforce include: - Medical
- Dental
- Vision
- Sick Pay (for applicable states/municipalities)
Our team stays close to the process and is here to guide you every step of the way. To learn more, please visit our website
ApTask Global Workforce is an Equal Opportunity Employer. Candidates will receive consideration without regard to their race, color, religion, sex, sexual orientation, gender identity, national origin, disability or status as a protected veteran.
