QA Specialist

Proclinical is seeking a QA Specialist for a leading biopharmaceutical company located in Frederick, MD. In this position, you will provide Quality Assurance oversight of Commercial Manufacturing, Materials Management, and Quality Control areas. Other responsibilities include:

Job Responsibility:

• Work with the Commercial Manufacturing, Quality Control, Materials Management and Facilities/Engineering departments as a Quality Assurance representative.
• Coordinate and facilitate Quality Assurance related production and production related activities, including on-the-floor Quality support to manufacturing, QC and Warehouse.
• Provides clerical and administrative support related to documentation processes and systems.
• Scans, verifies, and archives documentation and records as needed
• Ensure that tests are performed, and products are manufactured in compliance with Kite specifications, regulatory and GMP guidelines.
• Support development of SOPs and review/approve SOPs to ensure quality objectives are met
• Compile and verify all batch related documents into a final product lot disposition package
• Review and approve executed Manufacturing Production Records for regulatory and Kite compliance
• Provides support to clients on the process of documents in the DMS. and word processing tasks as needed.
• Participates in function meetings.
• Notifies manager of compliance questions and issues.
• Provides additional support and assistance on tasks and projects as directed by management.
• Willing to work on a weekend shift as needed.
• Additional duties as assigned.
• These duties can be delegated to designated deputies of a satisfactory qualification level as needed.

Skills and Requirements:

• Bachelor's degree in technical discipline (Biology/Chemistry/Microbiology/Engineering or related field)
• 1-3 years of experience in Quality Assurance or a GMP related field within a biotechnology, biologics, or pharmaceutical manufacturing facility.
• Knowledge of GMP, SOPs and quality systems.
• Ability to effectively negotiate and build collaboration amongst individuals. Strong interpersonal, verbal and written communication skills.
• Experience with change control practices and strategies. General knowledge of aseptic manufacturing processes.
• Proficient in MS Word, Excel, Powerpoint and other applications. Ability to communicate and work independently with scientific/technical personnel.
• Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based on changing priorities.

If you are having difficulty in applying or if you have any questions, please contact Miranda Gilmer at (+1) 570-277-7065 or m.gilmer@proclinical.com.

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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