Required to be on the floor and present to provide quality oversight for all critical manufacturing processes. Ability to make independent decision regarding quality related concerns or issues.
Demonstrates a proficient knowledge of the manufacturing process and site procedures.
Addresses daily quality concerns and questions related to operating and environmental issues. Implements and follows up on corrective actions.
Clearly communicates complex issues to Management personnel.
The primary focus of the Quality Engineer covers the following areas: On Floor oversight in Manufacturing and Packaging areas, Incoming Material Inspection/approval, Validation, Deviations, Commissioning and Qualifications of Facilities, Equipment and Processes, Review and disposition of batch records and packaging records.
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.
Initiate or execute Action Plan requirements as needed to address investigation or compliance related activities.
In coordination with Engineering Personnel, Evaluates the manufacturing areas, equipment, and processes for recommended improvements that will eliminate the potential for deviations.
Identify deviations and ensure the deviations are initiated according to procedure.
Manage metrics on a regular basis, as applicable Work closely with Production personnel to complete in process batch record review, resolved batch related issues, and complete timely final batch record approvals in order to meet release scheduling.
Ensure that current procedures are followed in connection with handling of complaints and recalls, returned goods, reprocessing and environmental monitoring.
Completion of gowning qualification and maintaining status for entry into Aseptic processing area. Must be able to demonstrate a sound knowledge of aseptic gowning practices.
Assist in analysis of inspection rejects; assist in root cause analysis and implementation of CAPAs.
Performs AQL checks on product when necessary and maintain AQL qualification status.
Complete monthly inspections of the physical conditions of the manufacturing support areas and report issues to MQA supervision.
Perform and document assessments of aseptic behavior inside the aseptic manufacturing area during filling, capping, and lyophilizer loading/unloading activities. Provide real time aseptic technique coaching and risk mitigation in the event of an aseptic technique violation.
Provide regular updates about aseptic behaviors to the production department, support groups and site leadership.
Participation in gathering of data needed for the Annual Product.
Collecting of data for Quality Monthly Report.
Perform additional tasks in relation to quality issues as agreed with the Quality Assurance Manager.
Manage and escalate Quality issues to the Quality Assurance Manager as needed.
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 part 210 and 211, cGMP’s, FDA, OSHA and other regulatory agencies.
Is cross-trained in all MQA & CQA functions and may provide backup support to CQA Specialists.
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.
B.S. in Life or Physical Science with one (1) to five (5) years equivalent education/professional experience
Experience Drafting and Authoring SOPs, not managing SOP document process or reviewing documentation. Proven ability to write clear, concise instructions that do not need to be rewritten or questioned. Work sample will be requested.
Knowledge of a GMP production facility and/or inspection processes required
Validation experience in Sterile Manufacturing Equipment and Processes, not primarily Lab experience. EXAMPLE: Autoclave, Clean Steam, Water for Injection, Compounding, HEPA Carts, Vial Washer, Lyophilizer.
Ability to critically evaluate and troubleshoot complex problems and articulate clearly to management is essential
Well-organized and detailed oriented professional, with strong verbal and written communication skills
Quality or Pharmaceutical certifications is a plus
Sterile Manufacturing experience with a commercial production site is strongly preferred
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. Work regularly under desirable conditions of the office setting but has occasional exposure to moderately disagreeable features of noise, heat or production conditions.
Any person shown at any time (either by medical examination or supervisory observation) to have an apparent illness or open lesions that may adversely affect the safety or quality of drug products shall be excluded from direct contact with components, drug product containers, closures, in-process materials, and drug products until the condition is corrected or determined by competent medical personnel not to jeopardize the safety or quality of drug products. All personnel shall be instructed to report to supervisory personnel any health conditions that may have an adverse effect on drug products.
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