Quality Control Investigation Writer

job summary:
Advance your life sciences career in High Point, NC, with a top-tier global pharmaceutical leader. We are seeking a Quality Control Investigation Writer to lead, author, and coordinate laboratory investigations supporting GMP-regulated manufacturing operations and ensuring full regulatory compliance.

location: High Point, North Carolina
job type: Contract
salary: $25 - 35 per hour
work hours: 9 to 5
education: Bachelors

responsibilities:

• Lead and author QC laboratory investigations for OOS, OOT, Environmental Monitoring (EM) excursions, and laboratory deviations.
• Collect, review, and evaluate laboratory data, chromatograms, and testing records to identify root causes and evaluate product impact.
• Facilitate cross-functional investigation meetings with QA, Microbiology, and Manufacturing stakeholders.
• Author and manage quality records including Deviations, CAPAs, and Change Controls.
• Prepare comprehensive investigation reports that adhere to internal standards, cGMP, and FDA expectations.
• Support QA during audit reviews and regulatory inspections by providing investigation documentation.

 
qualifications:

Required:

• Bachelor's degree in Chemistry, Microbiology, Biology, Biochemistry, Pharmaceutical Sciences, or a related scientific discipline.
• Minimum 2 years of experience in a cGMP-regulated pharmaceutical or biotechnology environment.
• Demonstrated experience authoring OOS, OOT, EM investigations, CAPAs, and Change Controls.
• Strong knowledge of FDA regulations, root cause analysis tools, and analytical/microbiological testing data review.

Preferred:

• Experience using electronic Quality Management Systems (eQMS) such as TrackWise.
• Minimum 1 year of 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 View email address on 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.