My client, is a well-established and growing, GMP product developer and manufacturer of consumer products (pharmaceutical and healthcare industry related).
The QA Manager is responsible for managing the site Investigation/CAPA system and will provide guidance and leadership to investigators and investigation teams through the process of root cause determination and corrective and preventative action planning, and verifying the effectiveness of corrective and preventative actions.
The incumbent will be expected to maintain an appropriate QA management presence not only on first shift, but as needed on 2nd and 3rd shifts, to efficiently and effectively manage proactively. The incumbent will also monitor and assess the effectiveness of the quality system by measuring, analyzing, interpreting and reporting on quality system performance to upper management.
As the main site investigations and CAPA coordinator, this role is responsible to train all site resources on system tools, investigative techniques, Root Cause Analysis (RCA) and CAPAs.
• Will work closely on cross-functional teams and closely with upper management to ensure and maintain a high level of quality system audit readiness
• Responsible for quality tracking system improvements with focus on CAPAs (closeouts, trending, etc.).
• Actively participate and provide guidance to investigators and investigation teams in complex investigations to ensure high quality and timely reports closure.
• Actively participates in internal audits of this quality system including response generation and execution of corrective and preventative actions resulting from internal audits.
• Participates on multi-functional continuous improvement (lean, six sigma, issue resolution, etc.) teams.
• Prepare and/or revise and assist with implementation of relevant SOPs related to this quality system.
• Bachelor’s degree in Chemistry, Engineering or other science related field of study.
Minimum of 7 years in Quality Assurance in a GMP regulated environment within the pharmaceutical or medical devices industry (manufacturing/production environment).
• Experience in conducting and handling investigations required.
• Proficient in the use of TrackWise or similar system is highly desirable.
• Excellent interpersonal effectiveness, written, and verbal communication skills
• Knowledge in Lean and Six Sigma principles highly desirable.
• Previous track record of utilizing lean/six sigma to improve quality systems
ASQ related certifications highly desirable.
• Must have previous direct supervisory experience, the ability to manage/mentor more than 5 direct reports, and the ability to manage others on multiple shifts.
• Excellent communication and analytical skills.
• Ability to think outside the box to provide compliant solutions and be able to work in a rapidly expanding organization.
• Must have a thorough understanding of the various productions needs, with emphasis in process investigations, and corrective and preventive actions.
NOTE: My client will only consider those candidates who do not require sponsorship to work in the US
Please additionally note: Only local candidates will be considered who are currently based within driveable distance Rockland County, NY (just North of the NJ/NY border) or candidates who will relocate themselves.
FPC - 17 months ago