About This Role
This QC Laboratory Analyst position supports quality control operations by performing sampling, testing, and documentation for raw materials, buffers, and process-related materials. The role focuses on safety and identity testing to ensure materials meet quality and regulatory standards before manufacturing use, following cGMP and data integrity standards. It is well-suited for an early-career scientist aiming to develop laboratory and quality system expertise.
Responsibilities
- Perform sampling of incoming raw materials, components, buffers, and process materials according to approved procedures and sampling plans
- Ensure proper handling, labeling, chain of custody, and storage of sampled materials
- Maintain sampling areas and equipment in a clean, organized, and compliant condition
- Support material disposition activities through timely collection and delivery of samples
- Conduct safety and identity testing of raw materials and buffers using approved analytical methods
- Prepare reagents, standards, and test solutions as required
- Accurately document testing activities and results in laboratory systems and controlled records
- Review test data for completeness and compliance with applicable procedures
- Escalate atypical results, deviations, and quality concerns to management
- Comply with cGMP, Good Documentation Practices (GDP), laboratory procedures, and site safety requirements
- Perform other duties as assigned
Requirements
’s degree in Chemistry, Biochemistry, Biology, Pharmaceutical Sciences, or a related life science field
- Laboratory experience with sample preparation, material handling, and analytical testing
- Knowledge of raw material sampling and identity testing
- Familiarity with cGMP, Good Documentation Practices (GDP), data integrity, and laboratory safety
- Ability to follow SOPs, sampling plans, and approved testing procedures
- Experience preparing reagents, standards, and test solutions
- Ability to accurately document and review laboratory data, test results, and observations
- Ability to identify and escalate atypical results, deviations, and quality concerns
- Strong attention to detail, organization, communication, and problem-solving skills
- Ability to work effectively in a fast-paced, regulated QC laboratory environment
Nice to have:
- Familiarity with LIMS or electronic laboratory systems
- Experience in a pharmaceutical, biotechnology, life sciences, or regulated manufacturing environment
- Experience with raw material or QC release testing
- Familiarity with basic analytical techniques such as pH, conductivity, and visual/physical inspection
Important Details
- Duration: 6 Months
- Contract: Temporary Assignment
About the Company
TekWissen is a global workforce management provider headquartered in Ann Arbor, Michigan that offers strategic talent solutions to clients worldwide. The client is a leading biotechnology company combining technological insight with world-class manufacturing, scientific expertise, and process excellence. They help customers deliver new and innovative medicines that treat a wide range of diseases, specializing in pharmaceutical ingredients, bioscience, biopharmaceuticals, custom manufacturing, biotechnology, life science ingredients, nutrition, microbial control, agriculture, materials science, personal care, and cell and gene therapy.
