Manager, QC Release

Merck KGaA Darmstadt Germany-posted 9 months ago
Full-time • Manager
Madison, WI
Chemical Manufacturing
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As the QC Release Manager, you will be accountable for management of a GMP Quality Control Department supporting custom starting materials, excipients, and API manufacturing testing according to IPEC, ICH guidelines and applicable FDA 21 CFRs. The 24/7 QC Release group consists of 5 QC supervisors and approximately 35 employees. You will lead all aspects of QC release activities associated with environmental monitoring, GMP in-process testing, GMP release testing and retest, stability, and reference standards. You will be responsible for the QC staff which conduct these activities within a Contract Development and Manufacturing (CDMO) site. All employees are responsible to adhere to the GMP requirements defined within 21 CFR parts 210 & 210, 820 and ICH Q7; and the safety standards set under ISO 14001 & 45001. The position, like all positions at MilliporeSigma, will require a willingness to contribute to the overall success of the company by assisting in many areas beyond specific job duties.

  • Assist the Quality Director in overseeing and managing the QC release systems.
  • Ensure that all materials and products that require testing and release in the laboratory are done so according to agreed specifications and procedures in a cGMP environment.
  • Demonstrate working knowledge of analytical instrumentation such as HPLC, IC, FTIR, GC, DSC, TGA, LC-MSMS, GC-MS, ICP-MS, NMR, KF, Polarimetry, UVVIS, and other wet lab equipment.
  • Demonstrate subject matter expertise in software programs such as Chromeleon, SAP, FileMakerPro, and scheduling tools.
  • Identify areas for improvement or use new technologies/equipment to gain efficiencies in the lab.
  • Manage direct reports, select new employees, act on employee issues, conduct performance and development reviews, provide disciplinary action, coordinate training and daily workload for direct reports, ensure efficient use of resources with the department budget and minimum turnaround times without compromising proper laboratory safety, quality or housekeeping practices.
  • Liaise with planning and project teams (internal and external) to build, maintain, and communicate the QC schedule.
  • Responsible for the safety of the QC areas and operations performed within.
  • Ensure laboratory documentation and computerized systems comply with data integrity policies and regulatory requirements.
  • Lead all aspects of the QC activities associated with material testing (finished product, intermediates, in-process sample) to support GMP product release.
  • Write, review, and approve GMP documents as required by local procedures.
  • Run a structured business process to ensure all QC tasks are captured and reported.
  • Represent QC Release matters during regulatory agency or customer inspections.
  • Manage laboratory resources (instruments and personnel) to provide a comprehensive analytical service for testing all QC samples.
  • Manage the investigation into any non-conformance, instrument malfunction, accident, or other abnormal occurrence. Ensure that any Out of Specification (OOS) or Out of Trend (OOT) analytical results are captured as per standard operating procedures (SOP).
  • Responsible for monitoring, statistically analyzing, trending, and reporting of QC data and metrics to evaluate performance and risks.
  • Effectively engage with the tools available to maintain a system for capacity planning and demand forecasts.
  • Lead and coach team members in continuous improvement across planning, metrics, and scheduling activities.
  • Minimum of a BS degree in a scientific field (chemistry, chemistry engineering, pharmacy, biochemistry, biology, or other related science)
  • Minimum of 8 years' experience in cGMP pharmaceutical quality control operation
  • Experience leading a team of direct reports.
  • Knowledge of Good Manufacturing Practices for pharmaceutical manufacturing (21 CFR 210, 211 and 820) and ICHQ7 Good Manufacturing Practices Guidance for APIs.
  • Knowledge in 21 CFR Part 11 and Data Integrity Guidelines for pharmaceutical manufacturing.
  • Pharmaceutical quality control operations experience in CDMO business
  • Proficient knowledge of and ability to use Microsoft Word, Excel, and Access.
  • Excellent interpersonal, written, and verbal communication skills
  • Results driven, team player, able to balance multiple projects/tasks.
  • Diversity and inclusion initiatives
  • Opportunities for professional development and growth
  • Collaborative work environment
  • Commitment to employee well-being and work-life balance
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