Quality Control Investigation Writer

About the role

The Quality Control Investigation Writer leads and authors complex laboratory investigations within a GMP-regulated pharmaceutical quality control environment. This role ensures that investigations are scientifically sound, fully compliant with regulatory expectations, and completed within established timelines. The position focuses on evaluating laboratory events, determining root cause and product impact, and documenting clear, defensible conclusions that support product quality, patient safety, and regulatory compliance.

Responsibilities

• Lead and manage laboratory investigations in a GMP-regulated pharmaceutical QC setting, ensuring all activities follow FDA and cGMP requirements.
• Conduct investigations for out-of-specification (OOS) and out-of-trend (OOT) results, environmental monitoring excursions, laboratory deviations, atypical events, invalid results, and data integrity issues.
• Analyze laboratory data, test methods, chromatograms, instrument records, worksheets, and environmental monitoring data to determine root cause and assess product impact.
• Facilitate cross-functional investigation meetings and discussions with Quality Control, Quality Assurance, Microbiology, Manufacturing, and laboratory leadership to gather information and align on investigation strategy and conclusions.
• Perform structured root cause analyses using tools such as fishbone diagrams and 5 Whys, and document scientifically justified conclusions supported by data.
• Write clear, detailed, and well-organized investigation reports that meet FDA expectations and cGMP standards, ensuring accuracy, completeness, and traceability.
• Develop and document product quality, patient safety, and compliance impact assessments based on investigation findings.
• Author and support deviations, corrective and preventive actions (CAPAs), and change controls, including defining effectiveness checks and tracking follow-up actions to completion.
• Support regulatory inspections, internal audits, and customer audits by providing investigation documentation, explaining investigation approaches, and answering questions related to laboratory events.
• Identify recurring laboratory issues, trends, and systemic gaps, and recommend process improvements to enhance data integrity, laboratory performance, and compliance.
• Collaborate closely with QC, QA, Microbiology, Manufacturing, and document control functions to ensure consistent investigation practices and robust documentation.
• Review analytical chemistry and/or microbiological testing data to support investigation conclusions and verify data integrity.
• Use electronic quality management systems, such as TrackWise or other eQMS platforms, to manage investigations, deviations, CAPAs, and change controls where applicable.

Requirements & Qualifications

• At least 2 years of experience working in a GMP-regulated pharmaceutical, biotech, or biologics environment, including hands-on involvement in investigations.
• Proven experience leading and writing QC laboratory investigations, preferably with at least 1 year directly focused on investigation authorship.
• Strong knowledge of FDA regulations and cGMP requirements related to laboratory operations and investigations.
• Demonstrated experience conducting root cause analysis using structured methods such as fishbone diagrams and 5 Whys.
• Technical writing expertise with a proven track record of authoring clear, comprehensive, and compliant investigation reports.
• Experience authoring OOS and OOT investigations, environmental monitoring investigations, laboratory deviations, CAPAs, and change controls.
• Ability to review and interpret analytical chemistry and/or microbiological testing data to support scientific evaluations and conclusions.
• Experience working in an aseptic environment, including investigations on isolator lines and within cleanroom-based quality control operations.
• Strong analytical and problem-solving skills with the ability to synthesize complex data and draw scientifically justified conclusions.
• Solid understanding of quality control, quality assurance, document control, and environmental monitoring principles in a GMP setting.
• Bachelor's degree in Chemistry, Microbiology, Biology, Biochemistry, Pharmaceutical Sciences, or a related scientific discipline.
• Hands-on experience conducting investigations in an aseptic manufacturing or QC environment, including work on isolator lines.
• Experience with electronic quality management systems, such as TrackWise or other eQMS platforms, is preferred.
• Familiarity with FDA guidance for OOS investigations and related regulatory expectations is preferred.
• Experience supporting FDA inspections, internal audits, and customer audits from a QC or QA perspective.
• Ability to collaborate effectively with cross-functional teams, including QC, QA, Microbiology, Manufacturing, and laboratory leadership.
• Strong attention to detail, organizational skills, and the ability to manage multiple investigations and deadlines simultaneously.
• Clear and concise communication skills, both written and verbal, with the ability to present investigation findings and rationale to diverse stakeholders.

Work Environment & Schedule

The role operates in a GMP-regulated pharmaceutical quality control environment with regular work in cleanroom and aseptic areas. The position follows a Monday through Friday schedule, typically from 8:00 a.m. to 5:00 p.m. Work involves close collaboration with QC, QA, Microbiology, Manufacturing, and document control teams, as well as interaction with electronic quality systems and laboratory data systems. The cleanroom setting requires adherence to strict gowning procedures, aseptic techniques, and environmental monitoring practices to maintain a controlled, compliant, and safety-focused workplace. This is a fully onsite position in High Point, NC.

Pay & Benefits

The pay range for this position is $20.00 - $36.00/hr. Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors.

• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan (Pre-tax and Roth post-tax contributions available)
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms.

Job Type & Location

This is a Contract position based out of High Point, NC. The position is anticipated to close on Nov 2, 2026.