QC Associate

Proclinical is currently recruiting for a Bioassay QC Associate with a biotechnology company located in Durham, NC.

Job Responsibilities:

• Release and stability testing.
• Technical leadership as a subject matter expert in one or more disciplines.
• Timely review/corrections for data and documentation.
• Execution of method transfer, method/reagent qualification, analytical improvement projects, and validation of analytical methods in collaboration with teams as appropriate.
• Supports maintenance of effective laboratory systems to ensure integrity of all laboratory results.

Skills and Requirements:

• Biological Science degree is preferred with 0-2 years of relevant experience (MS degree), 3-4 years of relevant experience (BS degree).
• Candidates should have experience with biological testing (bioassays, cell-based or not), ELISAs, potency and binding assays and extensive GMP experience, preferably in a commercial manufacturing environment.
• Excellent laboratory technique and experimental design.
• Experience with statistical experimental design and data analysis with JMP and Excel software, as well as relevant experience in reagent qualification, method validation and transfer is a plus.
• Excellent time management and prioritization skills.
• Excellent oral and written communication and presentation skills

If you are having difficulty in applying or if you have any questions, please contact Sarah Beshara at 267-477-3355.

ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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