Quality Control Analyst III
About The Position
TekWissen is a global workforce management provider headquartered in Ann Arbor, Michigan that offers strategic talent solutions to our clients world-wide. Our client is a leading biotechnology company that combines technological insight with world-class manufacturing, scientific expertise, and process excellence and helps their customers to deliver new and innovative medicines that help treat a wide range of diseases. Our client specializes in pharmaceutical ingredients, Bioscience, Biopharmaceuticals, Custom manufacturing, Biotechnology, Life science ingredients, Nutrition, Microbial Control, Agriculture, Materials Science, Personal Care, and cell and gene therapy.
Requirements
- 2+ years of experience in pharmaceutical Quality Control within a GMP-regulated environment.
- Hands-on experience with laboratory software and computerized systems, including SoftMax Pro, Empower, and/or SoloVPE.
- Experience supporting technical transfer, method validation, and/or software validation activities.
- Experience preparing, reviewing, or writing GMP procedures and validation documentation, including execution and documentation of validation test scripts.
- Experience serving as an SME for at least one laboratory or software system.
- Familiarity with GMP Quality Systems, including LIMS and/or TrackWise.
- Strong understanding and practical application of Data Integrity principles.
- Strong analytical, data interpretation, troubleshooting, and technical root-cause analysis skills, particularly for software-related issues.
- Proficiency with Microsoft Word, Excel, and PowerPoint.
- Strong written and verbal communication skills with the ability to collaborate effectively with cross-functional teams.
- Strong attention to detail and commitment to quality and compliance.
- Ability to work independently, manage multiple and complex assignments, and complete work accurately and on time.
Responsibilities
- Support QC activities associated with technical transfer and production.
- Utilize laboratory software systems such as SoftMax Pro, Empower, and SoloVPE.
- Support method and software validation activities.
- Write and contribute to GMP procedures and validation documentation.
- Execute validation test scripts and document results.
- Serve as an SME for at least one laboratory or software system.
- Perform technical root-cause analysis for software-related errors.
- Apply Data Integrity principles in all activities.
- Interpret and analyze laboratory and operational data.
- Collaborate with Quality Control, production, and other cross-functional teams.
- Follow GMP procedures, established instructions, and company quality requirements.
- Maintain required training and complete assignments accurately and on time.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Education Level
No Education Listed
