QC Analyst job in Gaithersburg, USA

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Last Name*

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Job type: Permanent

Discipline: Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), Good Pharmacovigilance Practice (GVP)

Location: United States

This vacancy has now expired. Please see similar roles below...

Proclinical is currently recruiting for an Assay Validation QC Analyst with a pharmaceutical company located in Gaithersburg, MD. We are seeking an Experienced Quality Control Analyst to join our Quality Control team. Qualified individuals will be responsible for performing assay qualification and validation as well as analytical testing on in-process samples, drug substance and drug product for release and in support of stability studies.

Job Responsibilities:

Under limited supervision, individually performs routine laboratory techniques and procedures.
Performs GMP release and stability testing in Quality Control
Analytical methods include: UV Spectroscopy, RP-HPLC, BCA, qRT-PCR, ELISA, SDS-PAGE, Capillary Electropheresis
Ensure that written records and work undertaken are performed in accordance with cGMP and company procedures
Participates actively in technology transfer, method qualification and validation
Keeps accurate testing records and assures that laboratory equipment has been calibrated, standardized, and monitored as appropriate
Assists in the writing, reviewing and editing of standard operating procedures
Write technical reports and supporting documentation such as deviation, CAPAs, reports, testing protocols, and trend analyses
Performs root cause investigation and analysis
Participates in continuous improvement projects
Assist in the maintenance of the lab including routine housekeeping activities
Maintain effective communication with other relevant groups, including but not limited to Quality Assurance, Manufacturing and Analytical Development
Other duties as assigned

Skills and Requirements:

Bachelor's degree in Biology, Molecular Biology, Biochemistry, Chemistry, Life Sciences, or other related discipline
Minimum of 1-2 years years of related experience working in a quality control laboratory environment
Knowledge and expertise in principles and practices of current Good Manufacturing Practices (GMPs)
Excellent analytical skills and knowledge
Strong troubleshooting skills for equipment and software
Excellent communication/interpersonal and presentation skills
Experienced with EHS guidelines in a laboratory environment

If you are having difficulty in applying or if you have any questions, please contact Mike Raletz at 267-428-7770.

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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