Quality Control Research Associate II

Proclinical is currently recruiting for a Level 2 Quality Control Research Associate position with an international biopharmaceutical company located in Oceanside, CA. Successful candidate will evaluate equipment for purchase and perform installations and qualifications of the new instruments.

*Local Candidates Only*

Specific Responsibilities:

• Review and/or test GMP In-process, Release, and Stability data such as: Osmolality, HPLC methods (e.g., Protein A Titer, Ion Exchange, SEC, and Peptide Map), ELISA plate based methods (such as Residual Host Cell Protein, Residual Protein A, Residual Host Cell DNA), pH, and Appearance
• Write, revise, and review procedures, protocols, and reports
• Investigate deviations and Out of Specification results from Gilead and/or Contract Testing Laboratories
• Identify Corrective and Preventative Actions
• Experience using laboratory and quality systems to document work (e.g., Labware LIMS, Empower, SoftMax Pro, and Trackwise)
• Independently plan and execute assignments through strong project and time management skills
• Transfer methods to Contract Testing Laboratories and review/audit data
• Drive improvements to existing Quality Systems and develop new Quality Systems when necessary Essential Functions:
• Conduct non-routine analysis of raw materials, intermediates, and finished product samples.
• Troubleshoot instrumentation and test methods.
• Assist in the training of QC staff as needed.
• Apply knowledge of current Good Manufacturing Practices (cGMPs) and Good Laboratory Working knowledge and proficiency with Microsoft Office software.
• Write and execute protocols and reports.
• Conduct routine analyses based on written procedures.
• Review data and results of testing to ensure compliance to appropriate specifications and protocols.

Skills and Requirements:

• 5+ years of experience with BS degree in a relevant scientific discipline.
• 3+ years of experience with MS degree in a relevant scientific discipline.
• Excellent communication and interpersonal skills are required.
• Strong working knowledge of cGMPs, pharmacopoeia, and regulatory requirements for testing and validation pertaining to the pharmaceutical industry.
• Working knowledge and proficiency with Microsoft Office software.
• Must be able to think critically and creatively and be able to work independently, determine appropriate resources for resolution of problems, and have strong organizational and planning skills.
• Experience with Microsoft Office software and LIMS

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please call Brendan Thalheimer at (+1) 215-531-5299 or upload your resume on our website - www.proclinical.com.

A full job description is available on request.

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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