Quality Control Investigation Writer

Category: Quality Assurance / Quality Control (QA/QC)
Industry: Pharmaceutical / Biotechnology
Location: High Point, NC
Pay Rate: $34- $36 Hourly

Position Summary

We are seeking an experienced Quality Control (QC) Investigation Writer to lead, author, and coordinate laboratory investigations in a GMP-regulated pharmaceutical manufacturing environment.

This role is responsible for developing scientifically sound, thorough, and compliant investigation reports addressing laboratory events, product quality concerns, and potential data integrity issues. The QC Investigation Writer will collaborate with Quality Control, Quality Assurance, Microbiology, Manufacturing, and other cross-functional teams to determine root causes, assess product impact, and establish effective corrective and preventive actions (CAPAs).

The ideal candidate will have hands-on experience authoring laboratory investigations, including Out-of-Specification (OOS), Out-of-Trend (OOT), Environmental Monitoring (EM) excursions, and laboratory deviations, along with strong technical writing skills and knowledge of FDA regulations and current Good Manufacturing Practices (cGMP).

Essential Duties and Responsibilities

• Lead and author laboratory investigations involving:

  • Out-of-Specification (OOS) results

  • Out-of-Trend (OOT) results

  • Environmental Monitoring (EM) excursions

  • Laboratory deviations and atypical laboratory events

  • Invalid assay and microbiological test results

  • Data integrity and documentation discrepancies

• Collect, review, and analyze laboratory data, analytical methods, chromatograms, worksheets, instrument records, environmental monitoring results, and supporting documentation.

• Determine probable root causes and assess potential impacts on product quality, patient safety, regulatory compliance, and laboratory operations.

• Facilitate investigation meetings with QC analysts, laboratory management, QA, Microbiology, Manufacturing, and other stakeholders.

• Conduct root cause analyses using established investigation tools and methodologies.

• Prepare clear, concise, scientifically justified investigation reports that meet internal procedures and applicable FDA and cGMP requirements.

• Develop comprehensive product and process impact assessments supported by documented evidence.

• Author and support quality records, including deviations, CAPAs, and change controls.

• Recommend appropriate corrective and preventive actions, effectiveness checks, and follow-up activities.

• Review investigation records for completeness, technical accuracy, regulatory compliance, and timely completion.

• Partner with Quality Assurance during investigation reviews, revisions, and approval processes.

• Support regulatory inspections, internal audits, and customer audits by providing investigation records and assisting with responses to inquiries.

• Identify recurring laboratory issues and recommend improvements to reduce repeat events and strengthen laboratory compliance.

Required Qualifications

Education

• Bachelor's degree in Chemistry, Microbiology, Biology, Biochemistry, Pharmaceutical Sciences, or a related scientific discipline.

Experience

• Minimum of 2 years of experience in a GMP-regulated pharmaceutical, biotechnology, or biologics environment.

• Experience authoring and supporting laboratory investigations, including OOS, OOT, Environmental Monitoring, and laboratory deviation investigations.

• Demonstrated experience preparing technical investigation reports and documenting scientifically justified conclusions.

• Experience with CAPAs and change controls.

• Experience reviewing analytical chemistry and/or microbiological testing data.

Technical Knowledge

• Working knowledge of FDA regulations, current Good Manufacturing Practices (cGMP), and laboratory investigation requirements.

• Understanding of laboratory operations, analytical testing, microbiological testing, and GMP documentation practices.

• Experience with root cause analysis and scientific evaluation of laboratory events.

• Knowledge of data integrity, product impact assessments, and quality risk management principles.

Preferred Qualifications

• At least 1 year of direct experience leading and authoring laboratory investigations within a Quality Control department.

• Experience using electronic Quality Management Systems (eQMS), such as TrackWise.

• Familiarity with FDA guidance on investigating Out-of-Specification test results for pharmaceutical production.

• Experience supporting regulatory inspections, audits, and investigation response activities.

Knowledge, Skills, and Abilities

• Advanced technical writing, investigation documentation, and report preparation skills.

• Ability to critically evaluate complex laboratory data and reach scientifically defensible conclusions.

• Strong understanding of root cause analysis tools and investigation methodologies.

• Excellent attention to detail and commitment to data integrity and regulatory compliance.

• Strong verbal and written communication skills.

• Ability to collaborate effectively with QC, QA, Microbiology, Manufacturing, and senior leadership.

• Excellent organizational and time-management skills, with the ability to manage multiple investigations and deadlines simultaneously.

• Commitment to continuous improvement and effective quality systems.

Key Competencies

• Technical Writing and Investigation Report Authoring

• Laboratory Investigation Expertise

• Root Cause Analysis

• GMP and FDA Regulatory Compliance

• Quality Management Systems

• Analytical and Scientific Problem Solving

• Product Impact and Risk Assessment

• Cross-Functional Collaboration

• CAPA and Change Control Documentation

• Continuous Improvement

Additional Information

• Shift: Not specified

• Training schedule: Not specified

• Assessment requirements: Not specified

• Personal protective equipment (PPE): As required by the work environment

How to Apply

Interested candidates should submit an updated resume highlighting their GMP-regulated laboratory experience, investigation writing expertise, OOS/OOT investigations, root cause analysis, and CAPA documentation experience.

Pay Details: $34.00 to $36.00 per hour

Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits and a 401K plan. Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs. In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable.

Equal Opportunity Employer/Veterans/Disabled

Military connected talent encouraged to apply

To read our Candidate Privacy Information Statement, which explains how we will use your information, please navigate to https://www.adecco.com/en-us/candidate-privacy

The Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements, including, as applicable:

• The California Fair Chance Act
• Los Angeles City Fair Chance Ordinance
• Los Angeles County Fair Chance Ordinance for Employers
• San Francisco Fair Chance Ordinance

Massachusetts Candidates Only: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.