Quality Control Scientist I
About The Position
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. The Data Review Scientist / Quality Control Scientist I will review analytical testing data associated with raw materials, in-process samples, finished products, and stability samples. The ideal candidate will have strong attention to detail, scientific judgment, and the ability to identify and resolve data or documentation discrepancies. The position requires experience in a chemistry, biology, microbiology, or biochemistry laboratory, preferably within a pharmaceutical, biotechnology, or other regulated environment.
Requirements
- Bachelor's degree in Chemistry, Biology, Biochemistry, Microbiology, or a related scientific field.
- Knowledge of GMP regulations, Good Documentation Practices, pharmaceutical quality standards, and data integrity principles is required.
- Strong attention to detail and ability to critically evaluate scientific data and identify discrepancies.
- Strong analytical, problem-solving, organizational, written, and verbal communication skills.
- Proficiency with Microsoft Office and laboratory information/electronic data systems such as LIMS.
- Ability to work independently and collaboratively in a dynamic environment.
- Strong commitment to quality, safety, compliance, and data integrity.
Nice To Haves
- 2+ years of relevant laboratory experience preferred, ideally within a pharmaceutical, biotechnology, or other regulated environment.
- Experience with laboratory data review and/or analytical laboratory testing preferred.
- Working knowledge of analytical techniques such as HPLC, GC, spectroscopy, dissolution testing, and wet chemistry.
- Experience working in a QC laboratory or regulated testing environment is highly preferred.
Responsibilities
- Review analytical data, laboratory records, and supporting documentation generated by QC laboratories.
- Review data from analytical techniques including HPLC, GC, spectroscopy, dissolution testing, and wet chemistry.
- Verify calculations, results, specifications, instrument outputs, chromatograms, and associated documentation for accuracy and completeness.
- Ensure laboratory records comply with approved methods, specifications, SOPs, GMP requirements, and Good Documentation Practices.
- Identify errors, discrepancies, atypical results, and documentation deficiencies and work with laboratory personnel to facilitate resolution.
- Review data associated with raw materials, in-process samples, finished products, and stability studies.
- Utilize LIMS and other electronic laboratory systems to review and track analytical data and sample status.
- Support investigations, deviations, OOS/OOT events, and other quality activities as assigned.
- Maintain accurate and traceable records in accordance with applicable data integrity requirements.
- Collaborate with QC analysts, laboratory leadership, Quality Assurance, and other cross-functional teams to support testing and product-release timelines.
- Follow applicable safety, quality, regulatory, and site procedures.
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What This Job Offers
Career Level
Entry Level
