What are the responsibilities and job description for the QC Manager position at Synerfac Technical Staffing?
Our client is seeking an experienced QC Manager to join their extensive team. In this role, you will be responsible for managing Quality Control staff and direct day-to-day operation of stability and reference programs in their Devens and North Andover, MA facilities. Is also responsible for analytical activities associated with stability testing, qualification of reference standards, laboratory equipment qualification, oversite of QC site of clinical and commercial GMP operations to ensure products are tested to comply with requirements ensuring safety and quality, analytics to support manufacturing from cleaning validation/verification to environmental monitoring.
Daily Responsibilities:
Daily Responsibilities:
- Manages day-to-day operations within the QC group in a fast-paced, dynamic work environment in compliance with current regulations and policies (FDA, OSHA, DEA, etc.)
- Schedules and manages day-to-day operations within the QC stability and reference standard group in a fast-paced, dynamic work environment in compliance with current regulations and policies (FDA, OSHA, DEA, etc.)
- Formulates and meets quality control objectives. Sets priorities with Operations and other managers to ensure quality and timelines are met to ensure material and products are tested, reviewed and approved within the accepted time frames. Interprets data and resolves technical issues.
- Reviews, authors, and edits documents, including stability protocols/reports, reference standard characterization reports, deviations, change control requests, SOPs, test methods and related technical reports necessary for laboratory operations.
- Actively participates with cross functional teams and shares information, as appropriate, with direct reports. Oversees QC-related compliance activates, including investigation closure of any OOS/OOT/Atypical Results/CAPA events.
- Actively directs/leads/performs investigations and implements corrective and preventative action plans.
- Implements procedures and optimal infrastructure to ensure compliance with all regulatory agencies. Serves as the department representative on regulatory audits.
- Provides accurate and timely delivery of data and support regulatory filings.
- Performs assessments of current systems, to provide guidance for impartments to or development of streamlined GMP systems.
- Champions the continuous improvement process, defining process improvement projects.
- Coaches, mentors, leads, and manages employees. Ensures that training and other personal development programs are in place for succession planning and the development of subordinates. Ensures that performance opportunities are managed through the performance management system.
- Provides leadership for supervisors, analysts, and technicians to optimize productivity and quality of work. Provides effective planning for department operations to include required resources, and the maintenance and communication of cycle times.
- BS in Chemistry or closely related discipline with extensive experience in Analytical and Quality Control support of Active Pharmaceutical Ingredient (API).
- 10 yeas in laboratory environment, preferably in API in GMP environment including 5 years managing a team.
- Extensive technical experience in analysis of small molecules, demonstrated knowledge of modern analytical techniques (HPLC, GC, KF, IR, NMR, DSC) and wet chemistry.
- Expertise and know-how with laboratory equipment in order to train staff and troubleshoot issues when needed.
- Knowledge of SAP, LIMS and project managements" experience desired.
- Ability to change priorities in response to company demands while continuing to deliver exceptional work quality.
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