Job description

Overview:

TekWissen group is a workforce management provider throughout the USA and many other countries in the world. Our client is a leading biotechnology company and combines technological insight with excellent manufacturing, scientific expertise and process excellence, that helps their customers to deliver new and innovative medicines that help treat a wide range of diseases. Our client specializes in pharmaceutical ingredients, Bioscience, Biopharmaceutical, Custom manufacturing, Biotechnology, Life science ingredients, Nutrition, Microbial Control, Agriculture, Materials Science, Personal Care, and cell and gene therapy.

Job Description:

• The Quality Control Analyst demonstrates understanding of executing QC test methods, generating associated data packages and auditing data generated by others and troubleshooting instrumentation.
• Responsible for identifying, alerting and proposing solutions to issues on instruments and or test executions.
• Knowledge of GMPs and their application to QC.
• Demonstrates attention to detail and appropriate safety consciousness.
• Summarizes and critically analyzes data for trending and reporting.
• Supports execution of internal and outsources analytical testing, analytical qualifications and stability studies of exosomes, biological molecules, oligonucleotides, small molecules and drug products. Aid in the development of QC strategy within the site and
• support external quality consultants as needed.
• Assist in building and maintaining strong working relationships with technical counterparts internally and externally.

Overview/Role Purpose:

• Main responsibilities include executing QC test methods for Wes, qPCR, DLS, NTA, UPLC and ELISA. Also assisting in review of GMP product characterization, release and stability data. This position will be performing routine QC testing in the laboratory.

Key Accountabilities and Duties:

• Performs routine and stability testing in the lab
• Performs method qualification, validation and verification under supervision
• Review of release, stability and characterization data.
• Assist in outsourcing of release and stability test methods, including test method transfer, assay qualification and troubleshooting
• Support all analytical activities for production of payloads, exosomes and drug product
• Generate complete, accurate and concise lab documentation
• At all times, comply with safety guidelines, GMPs and other regulatory requirements
• Performs other duties as assigned

Required Skills

• 0 to 4 years of previous experience in GMP environment.
• Background in analytical method development, analytical support of manufacturing campaigns, quality control, and method transfer.
• Knowledge of cGMP/ICH/FDA/EU regulations.
• Strong work ethic, strives to learn new things, and capable of working independently and in a collaborative environment.
• Excellent communication, project management, and presentation skills (oral and written).
• Proven record of accomplishment of being personable, energetic, responsive, empowering, inclusive, action oriented, accountable, and an effective communicator.

TekWissen® Group is an equal opportunity/affirmative action Employer (m/f/d/v) supporting workforce diversity.

Job Types: Full-time, Contract

Pay: $21.00 - $23.00 per hour

Application Question(s):

• Do you have experience working in a cGMP environment?
• Did you complete your Bachelor's in Biology or any relevant discipline?

Work Location: One location

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