Quality Control Chemist

Proclinical is currently recruiting for a Quality Control Chemist with a pharmaceutical company located in Fredrick, MD.

Job Responsibilities:

• Provide Training on Analytical Assays
• Provide technical support for assay performance and troubleshooting of analytical issues in the context of a GMP laboratory.
• Represent Commercial QC as a primary point of contact for analytical methods in collaboration with Manufacturing and Analytical Development organizations.
• Author and revise processes and procedures for analytical method and associated work streams.
• Establish processes and procedures for purchasing, implementation, training and maintaining QC equipment in collaboration with method subject matter experts
• Coordinate with stakeholders for equipment validation and manage validation activities in alignment with established timelines
• Responsibility for ensuring electronic data meets Part 11 requirements in alignment with internal procedures
• Lead teams to support deviations, investigations, CAPAs and change control activities as needed
• Identify and lead teams for lean improvement activities
• Author and support regulatory filings and response to questions
• Support inspection readiness activities
• Participate in generating training module and instruction led training material

Skills and Requirements:

• Bachelors degree required, Masters preferred
• 1-2 years of experience working in a pharmaceutical or biotech environment
• cGMP experience
• Experience in analytical testing, such as PCR, Flow Cytometry, ELISA, or other cell based assays

If you are having difficulty in applying or if you have any questions, please contact Dardiyani Littlejohn at 267-297-3331.

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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