Quality Control Investigation Writer

Job Summary Join a premier global pharmaceutical leader in High Point, NC, as a Quality Control Investigation Writer. In this crucial on-site role, you will lead, author, and coordinate laboratory investigations supporting GMP-regulated manufacturing operations to maintain strict regulatory compliance and high quality standards. location: High Point, North Carolina job type: Contract salary: $25 - 35 per hour work hours: 9 to 5 education: Bachelors Responsibilities Lead, author, and manage QC laboratory investigations including OOS, OOT, EM excursions, and laboratory deviations. Perform root cause analyses and collect, review, and evaluate technical laboratory data, analytical chemistry, and microbiological test results. Partner with cross-functional teams (QA, Manufacturing, Microbiology) to evaluate evidence and develop scientifically justified conclusions. Author and support associated quality records, including Deviations, CAPAs, and Change Controls. Prepare comprehensive investigation reports that adhere to internal cGMP standards and FDA regulatory expectations. Participate in internal audits and regulatory inspections by presenting clear investigation documentation. Qualifications Required: Bachelor's degree in Chemistry, Microbiology, Biology, Biochemistry, or a related scientific discipline. Minimum 2 years of experience in a cGMP-regulated pharmaceutical, biotechnology, or biologics environment. Direct experience writing OOS, OOT, EM investigations, laboratory deviations, CAPAs, and Change Controls. Strong knowledge of FDA regulations, cGMP requirements, root cause analysis tools, and analytical/microbiological testing data. Preferred Experience using electronic Quality Management Systems (eQMS) such as TrackWise. Direct experience authoring and leading QC laboratory investigations. skills: Biology, Chemistry, Microbiology, Good Manufacturing Practices (GMP), Corrective and Preventive Actions (CAPA), Quality Control (QC) Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status. At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com. Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility). This posting is open for thirty (30) days. u9000030197