Quality Assurance ( QA ) Manager
TxMQ is currently assisting their client in the search for a qualified QA Manager for their FDA regulated manufacturing facility in Western NY due to the promotion of the current Manager.
REPORTING TO: Senior Director of QA
• QA Manager will independently perform duties related to various projects and/ or investigation processes. Typical projects include: new products/technologies, facility construction/renovation, product-line segregation (i.e., hormones and antineoplastic products), and other projects. The incumbent will provide quality & compliance guidance, direction, and focus to the team/investigation and will work within time-lines & budgets to ensure desired outcomes are achieved.
PRINCIPLE ACTIVITIES PERFORMED BY THE SUCCESSFUL CANDIDATE:
• Ensure projects’ time-lines and budgets are met and any deviations are timely communicated to senior site management.
• Thorough review and analysis of deviations which may include both quality and manufacturing deficiencies.
• Reviews and approves product development reports. i.e.: filter retention studies, product hold times, paraben concentration studies and product stability.
• Approval and analysis for evaluation of defect levels.
• Reviews cleaning validation studies to support the effectiveness of current cleaning programs.
• Provide assistance in troubleshooting in both manufacturing and quality related issues.
• Approval of validation qualifications/ re-qualifications.
• Support new product development and manufacturing initiatives
• Reviews and approves standard operating procedures.
• Approval of environment excursions and anomalies.
• Analyze and approve new manufacturing processes and innovations.
• Performs first of code batch record review.
• Review and approve work orders and critical change request.
• Follow up and monitor action plan effectiveness evaluation and review.
• Approve document change control request.
• Assess, evaluate, and determine compliant course of action for any of the following areas as they relate to project, investigation or process improvement: Engineering, Chemistry, Microbiology, Computer part 11, Solid and Liquid Manufacturing, Sterilization Assurance and Aseptic Manufacturing.
• Responsible for internal documentation meeting minimum cGMP requirements.
• Coordinate with FDA during inspection processes.
• Approve, create and/or revise validation, engineering, laboratory, and database documents to ensure the documentation is accurate, complete, thorough, cGMP compliant, and meets various external requirements (i.e., ISO, GAMP, ISPE, etc.).
• Research, investigate, and provide guidance to the team concerning technology, compliance, quality, and creative solutions to ensure the project or investigation are successful.
• Review and advise on risk assessment for all areas of the facility management, from construction & remodeling to product & cross-contamination impacts.
• Ensure validation activities are performed in accordance with SOPs and regulatory requirements.
• Ensure facility engineering, PM & calibration programs are performed in appropriate & timely manner.
• Ensure investigations are completed in a timely manner and are cGMP compliant.
• Ensure regulatory guidance updates are transitioned into appropriate procedures, practices, policies and activities in a timely manner.
• Ensure validation programs/methods for computer/ laboratory equipment are performed in accordance with SOP’s and other regulatory requirements.
• Review and approve quality documents such as: Batch Records, Product Specifications & Test Methods, Masterplans, IQ/OQ/PQ’s, PV, CV, CSV’s, DQ, URS, FAT/SAT’s, Drawings/P&IDs, and Policies/SOP’s.
• Make Quality Assurance related decisions at a leadership level within the plant from the technical review for various quality areas.
• BS/BA degree is required. 10-15 years of related work experience in a pharmaceutical industry with an emphasis on cGMP are required if no BS/BA degree is attained. At least 7-10 years of industry experience with BS/BA.
• Must possess strong interpersonal and written/verbal communication skills.
• Must be able to interface with Regulatory Agencies, Vendors and other departments across the Company
• The compensation package is competitive and will include an excellent benefits package, bonus and relocation assistance for the right candidate.
HOW TO APPLY:
• Interested and qualified candidates should submit a Word formatted resume, employment references, and salary history for immediate consideration.
• TxMQ would like to extend thanks to all applicants, however, only those that may qualify for the position will be contacted for a preliminary interview screening.
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