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Individual will train on first for a period of time and then transfer to the hybrid shift.

QA Specialist, Pharmaceutical Production Support

Job Summary The QA Specialist Production support performs his/her roles and responsibilities as part of the Quality Assurance department operating at the Wilson, NC facility. The primary responsibility is to assure compliance to cGMP's, client's policies, standard operating procedures, and FDA requirements. The incumbent will serve as a key resource for conducting product complaints, supports manufacturing and packaging oversite as QA oversite, and for IQA handles scheduling, planning, and collecting test/retain samples from incoming raw materials and components and assuring raw materials, packaging components, intermediates, and 3rd party contractor lots are received tested, and processed within approved procedures and regulatory requirements.

Primary Responsibilities

• Performs sampling and inspecting of samples from incoming commercial and experimental/clinical raw materials and packaging components, intermediates, and 3rd party contractor lots.
• Performs raw material and component review to ensure correct quantities, labeling and visual appearance.
• Effectively performs activities and applies knowledge in accordance with approved SOPs, company policies, cGxPs, regulatory requirements, schedules and provides technical expertise and direction to colleagues. Understands GxP regulations in other disciplines and impact on cross function areas.
• Understands and operates all necessary equipment and instrumentation to perform activities.
• Maintains documentation in accordance with internal procedures and regulatory requirements (i.e., GMP, SOPs etc.).
• Prepares and maintains tracking/testing systems, (i.e., LIMS, SAP Logbooks, OCR, Webscan, etc.) which are used for testing and to reflect the status of samples. Reports status to appropriate laboratory, manufacturing, and planning groups at pre-determined intervals. Applies technical principles, concepts and understanding of systems (SAP and TrackWise) as well as proficiency in Excel and Word.
• Interfaces with appropriate Warehousing, Planning, Pharmacy, Operations and Quality management to implement the procedural requirements as outlined and within internal operating procedures.
• Performs activities for MQA (i.e., Online batch record review, Packaging Line Clearances and Manufacturing Room Clearances, Deviation, AQL assistance/oversight).
• Notifies immediate supervision of any issues related to job function and recommends solutions in a timely manner.
• Comprehend and adhere to all pertinent Health and Safety regulations, policies and procedures and the required use of all approved and issued Personal Protective Equipment.
• Responsible for compliance with Controlled Substance documentation and accountability procedures and policies, maintaining high alert to diversion and theft possibilities.
• Demonstrates a level of consciousness to safety and health related activities as evident by the daily application of requirements specific to job function; recognize safety and health related issues and report to management.
• Independently searches, gathers, and presents information to support compliance with regulations and internal systems.
• Performs other related assignments and duties as required and assigned.

Education and Experience BS in a related Science preferred; and 5 years minimum experience, or equivalent level of experience in pharmaceutical or related industries.

Necessary Knowledge, Skills, and Abilities A thorough understanding and working knowledge of Quality systems and tools. Demonstrates working understanding, full knowledge, and ability in primary discipline. Applies technical principles, concepts and understanding of systems and procedures. Working knowledge of GxP regulations in other disciplines and impact on cross-functional areas.