Job description

Sagent Pharmaceuticals Raleigh, NC
MQA Specialist
This position will provide quality oversight to all manufacturing areas to ensure product quality and SOP/GMP compliance at the Raleigh Manufacturing Facility. Has extensive knowledge of the manufacturing process and routinely evaluates and resolves process issues in cooperation with Production and support personnel to ensure product safety. Works closely with Production personnel to complete on-the-floor, in-process batch record review, resolve all batch related issues, and ensure proper good documentation practices. Recommend corrective actions or process improvements that will eliminate the potential for manufacturing deviations.
Key Responsibilities

• Required to be on-the-floor and present to provide quality oversight for all critical manufacturing processes. Ability to make independent decisions regarding quality related concerns or issues.
• Works closely with Quality Management, as needed.
• Demonstrate a proficient knowledge of the manufacturing process and site procedures.
• Addresses daily quality concerns and questions related to operating and environmental issues.
• Clearly communicate complex issues to Management personnel.
• Evaluates the manufacturing areas for recommended improvements that will eliminate the potential for deviations.
• Work closely with Production personnel to complete in-process batch record review, resolve batch related issues, and complete timely final batch record approvals in order to meet release scheduling.
• Completes gown qualification and maintains status for entry into Aseptic processing area. Must be able to demonstrate a sound knowledge of aseptic gowning practices.
• Identify deviations and ensure the deviations are initiated by the appropriate personnel.
• Initiate or execute Action Plan requirements as needed to address investigation or compliance related activities.
• Assists in analysis of inspection rejects; assists in investigation of causes and implementation of corrective actions.
• Performs AQL checks on product when necessary and maintain AQL qualification status.
• Perform and document assessments of aseptic behavior inside the aseptic manufacturing area during filling, capping, and lyophilizer loading/unloading activities. Incumbent must be able to provide real-time aseptic technique coaching and risk mitigation in the event of an aseptic technique violation.
• Inspect the physical conditions of the aseptic manufacturing area on a routine basis.
• Provide good aseptic technique and gown re-training to individuals, as required per the RPN program.
• Provide backup support to the Environmental Monitor group as needed and as approved by management.
• Perform additional duties and responsibilities as assigned.
• Ensure processes and products are in compliance with all local, state, and federal rules and regulations. Oversee that processes are in CGMP compliance, and establish systems that identifies opportunities for improvement and makes constructive suggestions for change to improve process effectiveness to heighten quality. Develop knowledge of and understand regulatory requirements such as 21CFR Parts 210 and 211, cGMPs, FDA, OSHA and other regulatory agencies.
• Personnel engaged in the manufacture, processing, packing, or holding of a drug product shall wear clean clothing appropriate for the duties they perform. Protective apparel, such as head, face, hand, and arm coverings, shall be worn as necessary to protect drug products from contamination.

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Requirements*

• Bachelor of Science degree in Life or Physical Sciences with one (1) to five (5) years equivalent education/professional experience.
• Pharmaceutical industry experience desirable.
• Must have a strong work ethic and be highly motivated to resolve issues.
• Quality or Pharmaceutical certifications a plus.
• Visual acuity to detect defective vials during the evaluation of defects and AQL checks.
• Oral and written communication skills required between department, as well as levels of management.
• Computer experience required; must be proficient in Microsoft Word and Excel functions.

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Physical Requirements of the Role*
Position is exposed to a number of environments, office, lab, outside, plant floor, etc. This role is continuously sitting and typing. Frequently talking and using eye and hand coordination. Occasionally requiring lifting and carrying less than 10 lbs. Standing, walking, bending over, and repetitive use of legs are done occasionally.

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Sagent Pharmaceuticals is an EEO/AA employer and does not discriminate on the basis of race, color, religion, sex, age, creed, national origin, veteran status, physical or mental disability and sexual orientation_

Job Type: Full-time

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