QA Specialist job in El Segundo, USA

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First Name*

Last Name*

Email*

Phone Number*

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First Name*

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Phone Number*

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Are you an employer or a jobseeker?*

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Job type: Permanent

Discipline: Good Manufacturing Practice (GMP)

Location: United States

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

Proclinical is currently recruiting for a QA Specialist with a pharmaceutical company located in El Segundo, CA.

Job Responsibilities:

Coordinate the development and scientific material review process in the US to ensure the high volume of content
Provide on-the-floor QA oversight and support to ensure compliance to GMP throughout the area
Provide Quality Assurance support involving manufacturing production issues
Ensure that company products are manufactured in compliance with site, regulatory and GMP guidelines
Ensure timely issuance of production records and labels
Elevate issues affecting lot production or release to Management in a timely manner
Ensure approval and timely delivery of Final Product
Review and approve executed Manufacturing Production Records for regulatory and company compliance
Compile and verify all batch-related documents into a Final Product lot disposition package
Perform quality review and/or investigations of manufacturing deviations, GMP and Quality
System issues, non-conforming materials, and CAPA, as needed
Gather metric information for use in continuous improvement of areas of responsibility, as needed
Perform other duties as required to fulfill department and business needs

Skills and Requirements:

Bachelor's degree in technical discipline (Biology/Chemistry/Microbiology/Engineering or related field) with a minimum of 2-4 years of experience in Quality Assurance, Quality Control, or a GMP related field within a biotechnology, biologics, or pharmaceutical manufacturing facility
Working knowledge of GMP, practices/principles
Knowledge of relevant ICH and FDA guidance documents
Experience in identifying deviations and CAPA
General knowledge of aseptic manufacturing processes
Proficient in MS Word, Excel, Power Point and other applications
Strong written and verbal communication skills

If you are having difficulty in applying or if you have any questions, please contact Catherine Nguyen at 215-531-5643.

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.

#LI-CN1

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