Quality Associate

Proclinical is currently recruiting for a Quality Associate with a biopharmaceutical company located in North Chicago, IL. The Quality Associate applies scientific knowledge to daily operations, data management, and problem solving. Understands and follows documentation. Analyzes basic/simple data, evaluates results, forms conclusions, and recommends process and/or document improvements. Recognizes deviation from normal operating procedures. Recognizes and troubleshoots instrumentation and/or work order problems and routine operational issues. Participates in change control activities at a basic level. Perform inspecting, sampling, and physical testing of work-in-process and final packaged products per appropriate product specification in both a production and laboratory environment.

Job Responsibilities:

• Disposition incoming material for use in manufacturing and/or manufactured material for product for sale.
• Obtains and maintains certification in assigned job responsibilities.
• Participates in activities such as product/process improvement, troubleshooting, complaint handling, failure investigations, stability testing, CAPA documentation, and customer support.
• Understands, implements, and maintains the quality policy and ensures compliance to site level policies and procedures.
• Develops knowledge of products and technologies. Interacts on a necessary basis with internal and external support groups to perform core skills.
• Participates in team activities and area metric tracking.
• Responsible for performing routine testing on in-process and finished product in accordance with approved specifications and procedures.
• Responsible for supporting Operations efforts in meeting established production schedule.
• Reports problems in a timely and accurate manner.
• Seeks additional guidance or advice when problem is beyond scope of training or knowledge.
• Disposition incoming material for use in manufacturing and/or manufactured material for product for sale.
• Obtains and maintains certification in assigned job responsibilities.
• Participates in activities such as product/process improvement, troubleshooting, complaint handling, failure investigations, stability testing, CAPA documentation, and customer support.
• Understands, implements, and maintains the quality policy and ensures compliance to site level policies and procedures.
• Develops knowledge of products and technologies. Interacts on a necessary basis with internal and external support groups to perform core skills.
• Participates in team activities and area metric tracking.
• Responsible for performing routine testing on in-process and finished product in accordance with approved specifications and procedures.
• Responsible for supporting Operations efforts in meeting established production schedule.
• Reports problems in a timely and accurate manner.
• Seeks additional guidance or advice when problem is beyond scope of training or knowledge.
• Disposition incoming material for use in manufacturing and/or manufactured material for product for sale.
• Obtains and maintains certification in assigned job responsibilities.
• Participates in activities such as product/process improvement, troubleshooting, complaint handling, failure investigations, stability testing, CAPA documentation, and customer support.

Skills and Requirements:

• High School Diploma required.
• Good understanding of basic math
• Good clerical skills is required.
• 4+ years of overall work experience
• Computer skills proficiency including word processing, spreadsheets, instrumentation related and network systems.
• Previous experience in Quality Assurance
• 2+ Experience in a manufacturing/finishing environment is desired.
• Previous knowledge of GMP regulations and standards affecting pharmaceutical products is desired.

If you are having difficulty in applying or if you have any questions, please contact Samantha Reader at 267-536-3075.

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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