QC Laboratory Investigation Specialist

Job Description

Position: QC Laboratory Investigation Specialist

Location: High Point NC 27265

Duration: 12 Months

Job Type: Temporary Assignment

Work Type: Onsite

Shift: Day shift

Pay: $25 to $34 per hour

Overview:

TekWissen is a global workforce management provider headquartered in Ann Arbor, Michigan that offers strategic talent solutions to clients worldwide. The job opportunity below is with one of our clients specializing in biotechnology product development services. The client is dedicated to supplying laboratory equipment, chemicals, supplies, and services essential in healthcare, scientific research, safety, and education. As a global leader in serving the scientific community, the organization generates approximately $40 billion in annual revenue and is committed to making the world healthier, cleaner, and safer. Their global team delivers innovative technologies, convenient procurement solutions, and pharmaceutical services through industry-leading brands.

Position Summary

The Quality Control (QC) Investigation Writer / QC Laboratory Investigation Specialist is responsible for leading, authoring, and coordinating laboratory investigations within a GMP-regulated pharmaceutical, biotechnology, or biologics environment. This role ensures investigations are scientifically sound, thoroughly documented, compliant with applicable regulatory requirements, and completed within established timelines. The position collaborates with QC, Quality Assurance, Microbiology, Manufacturing, and other cross-functional teams to identify root causes, assess product impact, and develop effective corrective and preventive actions (CAPAs).

Responsibilities

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• Lead and author laboratory investigations related to Out-of-Specification (OOS) results, Out-of-Trend (OOT) results, Environmental Monitoring (EM) excursions, laboratory deviations, atypical laboratory events, invalid assay results, and microbiological testing issues.
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• Review and analyze laboratory data, test methods, chromatograms, worksheets, instrument records, environmental monitoring data, and supporting documentation to determine probable root causes and assess product impact.
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• Facilitate investigation meetings with laboratory personnel and cross-functional stakeholders to gather facts, evaluate evidence, and establish scientifically justified conclusions.
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• Perform and document root cause analyses using established investigation tools and methodologies.
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• Prepare clear, concise, and comprehensive investigation reports in accordance with internal procedures, regulatory expectations, and current Good Manufacturing Practices (cGMP).
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• Conduct scientific impact assessments to evaluate potential effects on product quality, patient safety, regulatory compliance, and laboratory operations.
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• Author and support quality records, including deviations, Corrective and Preventive Actions (CAPAs), and Change Controls.
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• Ensure investigations include appropriate corrective and preventive actions, effectiveness checks, and follow-up activities.
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• Review investigation records for completeness, technical accuracy, regulatory compliance, and timely closure.
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• Support Quality Assurance during investigation reviews, approvals, and resolution of documentation gaps.
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• Participate in regulatory inspections, internal audits, and customer audits by providing investigation documentation and supporting responses to inquiries.
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• Identify recurring laboratory issues and recommend process improvements to prevent repeat events and strengthen laboratory compliance.
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Required Skills and Qualifications

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• Bachelor's degree in Chemistry, Microbiology, Biology, Biochemistry, Pharmaceutical Sciences, or a related scientific discipline.
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• Minimum 2 years of experience in a GMP-regulated pharmaceutical, biotechnology, or biologics environment is required.
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• Direct experience authoring and leading QC laboratory investigations is required.
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• Hands on experience writing OOS investigations, OOT investigations, Environmental Monitoring investigations, laboratory deviations, CAPAs, and Change Controls is required.
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• Strong knowledge of FDA regulations, cGMP requirements, and regulatory expectations related to laboratory investigations.
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• Experience conducting scientific evaluations and root cause analyses for laboratory events.
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• Experience reviewing analytical chemistry and/or microbiological testing data.
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• Advanced technical writing, scientific documentation, and investigation report preparation skills.
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• Strong understanding of laboratory operations, analytical testing, microbiological testing, and GMP documentation practices.
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• Ability to critically evaluate complex laboratory data, identify discrepancies, and develop scientifically defensible conclusions.
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• Knowledge of investigation methodologies, root cause analysis tools, and quality risk management principles.
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• Experience with electronic Quality Management Systems (eQMS), such as TrackWise, preferred.
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• Familiarity with FDA guidance on investigating OOS test results for pharmaceutical production and applicable cGMP regulations.
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• Strong communication and cross-functional collaboration skills when working with QC, Quality Assurance, Manufacturing, and senior leadership.
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• Excellent organizational skills and the ability to manage multiple investigations simultaneously.
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• Strong attention to detail and commitment to data integrity, regulatory compliance, and continuous improvement.
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TekWissen® Group is an equal opportunity employer supporting workforce diversity.