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.
Summary
We are seeking a detail-oriented QC Scientist I / Quality Control Analyst to support laboratory testing, quality assurance, and regulatory compliance activities in a pharmaceutical or biotechnology environment. The ideal candidate will have hands‑on experience with analytical testing techniques, laboratory instrumentation, microbiological testing, and quality control procedures. This position involves performing laboratory analyses, maintaining accurate documentation, supporting equipment calibration and maintenance, and ensuring compliance with current Good Manufacturing Practices (cGMP), Good Laboratory Practices (GLP), Good Documentation Practices (GDP), and established Standard Operating Procedures (SOPs).
Responsibilities
- Perform routine quality control laboratory testing and analytical analyses in accordance with established SOPs and regulatory requirements.
- Utilize analytical techniques and instrumentation such as HPLC, ICP-MS, UV-Vis spectroscopy, flow cytometry, NMR, absorption spectroscopy, and dissolution testing, as applicable.
- Conduct chemical, biochemical, and microbiological testing to support product quality and compliance requirements.
- Apply aseptic techniques and appropriate laboratory practices when performing microbiological testing.
- Prepare, analyze, and document laboratory samples using established testing procedures.
- Maintain accurate and detailed laboratory records in accordance with Good Documentation Practices (GDP).
- Operate, maintain, troubleshoot, and calibrate laboratory equipment to ensure reliable analytical performance.
- Record, review, and manage analytical data using Laboratory Information Management Systems (LIMS), analytical software, and Microsoft Office applications.
- Follow current Good Manufacturing Practices (cGMP), Good Laboratory Practices (GLP), and applicable quality management system requirements.
- Support laboratory investigations, troubleshooting, and resolution of analytical or testing-related issues.
- Ensure laboratory activities comply with applicable pharmacopeial standards, regulatory guidelines, and internal quality procedures.
- Maintain a clean, organized, and safe laboratory environment while following established safety protocols and PPE requirements.
- Collaborate with laboratory personnel and cross-functional teams to support quality control operations.
- Manage multiple testing assignments and priorities while maintaining accuracy and meeting established timelines.
Required Skills
- Bachelor's degree required, preferably in Chemistry, Biochemistry, Biology, Molecular Biology, or a related scientific discipline.
- Minimum 2 years of experience in a quality control laboratory environment; pharmaceutical or biotechnology industry experience preferred.
- Strong knowledge of current Good Manufacturing Practices (cGMP), Good Laboratory Practices (GLP), Good Documentation Practices (GDP), and quality management systems.
- Proficiency in analytical techniques such as HPLC, ICP-MS, UV-Vis spectroscopy, flow cytometry, NMR, absorption spectroscopy, and dissolution testing.
- Knowledge of organic chemistry and analytical laboratory testing principles.
- Experience with microbiological testing methods and aseptic laboratory techniques.
- Ability to follow Standard Operating Procedures (SOPs) and maintain accurate laboratory documentation.
- Experience operating, maintaining, troubleshooting, and calibrating laboratory instrumentation.
- Proficiency with Laboratory Information Management Systems (LIMS), Microsoft Office, and analytical data management software.
- Familiarity with applicable pharmacopeial standards and pharmaceutical regulatory requirements.
- Strong analytical, troubleshooting, and problem-solving abilities.
- Excellent attention to detail, organizational skills, and commitment to data accuracy.
- Effective written and verbal communication skills.
- Ability to work independently and collaboratively in a team-oriented laboratory environment.
- Strong time management skills with the ability to handle multiple priorities effectively.
- Flexibility to accommodate changing schedules and laboratory operational requirements.
- Ability to perform laboratory activities safely while wearing required Personal Protective Equipment (PPE).
TekWissen® Group is an equal opportunity employer supporting workforce diversity.