Job description
Quality Analyst I - 6012
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Job Description
POSITION SUMMARY
Under minimum supervision, ensures compliance to cGMP regulations in manufacturing area including all documentation complying with the company’s Standard Operating Procedures (SOPs), governmental regulations and other requirements where applicable. Facilitates communication between departments to ensure a smooth flow of materials and release. Reviews and release raw, intermediate and finished materials. Leads quality assurance initiatives and implementations.
ESSENTIAL AREAS OF RESPONSIBILITY
- Carries out responsibilities in accordance with the organization’s policies, procedures, and state, Federal and local laws.
- Perform daily walkthroughs of all production areas in accordance with site procedures
- Reviews executed Batch Records, Raw materials, Logbooks, Work Orders
- Update SOPs for the review and release of finish goods and raw materials.
- Confirm products to be released in SAP.
- Assist in the training of new analysts in job duties according to Standard Operating Procedures (SOP), current Good Manufacturing Practices, (cGMP) and Company training procedures.
- Review and release raw, intermediate and finished materials and products, as well as their corresponding batch records.
- Interfaces with manufacturing, warehouse, QC, and materials management to ensure timely and accurate manufacturing and shipment of materials and products.
- Verifies and revise QA SOPs as required
- Maintains QA documentation files, database and logs.
- Responsible for performing AQLs and determining acceptance/reject results.
- Responsible for performing additional related duties as assigned.
- Responsible for initiating, writing and /or approving deviation records.
- Responsible for Quality oversight of shopfloor.
Qualifications
POSITION REQUIREMENTS
Any equivalent combination of education, training and/or experience that fulfills the requirements of the position will be considered.
Education/Certification/Experience:
Minimum Qualifications: High School Diploma or equivalent and five (5) years manufacturing and/or Quality Assurance environment experience.
Skills/Knowledge/Abilities:
- Establishing and maintaining cooperative working relationships with others.
- Reading, reviewing, sampling, and maintaining inventories and logs for materials in assigned area.
- Reading, understanding, interpreting and complying with current Company policies and procedures including safety rules and regulations.
- Communicating clearly and concisely, both orally and in writing.
- Operating personal computer and database software.
Function
Sub Function
Reports To
Already Working @TEVA?
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