|Date Posted||November 13, 2020|
|Address||645 Science Drive|
A career with MilliporeSigma is an ongoing journey of discovery: our 57,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance materials. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others. MilliporeSigma is a business of Merck KGaA, Darmstadt, Germany.
Your role: The primary responsibility of the Quality Control cleaning validation and stability supervisor is to manage QC validation (Cleaning) and stability team.
Reporting to the Site Head of Quality and in partnership with the Material Science & Technology (MSAT) team, the QC supervisor will develop and manage the Sites cleaning validation program for a Contract Manufacturing Organization (CMO) of Active Pharmaceutical ingredients (API).
In addition, this QC supervisor will be responsibility for the management of the stability program to ensure that processes and procedures are in compliance with cGMP and other appropriate regulations and standards as appropriate for Active Pharmaceutical ingredient (API) manufacture.
The QC Cleaning validation and stability supervisor possess detailed knowledge of cGMP. Highly developed interpersonal, written and verbal skills, including the ability to design and develop the cleaning validation strategy and stability program. They must be able to establish stong collaborative relationships with all departments within the organization to deliver on quality and regulatory commitments and have the ability to work autonomously, effectively manage time and deliver results on time.
The responsibilities of the role include:
- Leading and developing a team of qualified professionals to manage all Quality control aspects of the cleaning validation and stability program to ensure that process and procedures are in compliance with cGMP for API manufacture in a Contract manufacture organization.
- Collaborating with customers and the Material Science and Technology group (MSAT) to determine the appropriate cleaning validation strategy for the site and customer specific projects.
- Developing and validating analytical methods to detect the specified level of contamination that are to be used to verify the success of the cleaning process.
- Selection of analytical and sampling methods appropriate to the product life cycle and determination of appropriate limits.
- Setting health-based exposure limits for determining safe threshold values for the cleaning of API’s in shared facilities.
- Application of Acceptable Daily Exposure (ADE) or Permitted Daily Exposure (PDE) as necessary to decide if Dedicated Facilities/equipment are required and to define the Maximum Acceptable Carry Over (MACO) of API’s in particular, in multi-purpose equipment.
- Compilation, development and execution of associated validation documentation in line with GMP standards.
- Demonstrating the ability to provide leadership and organize departmental staff to meet deadlines without compromising quality.
- Managing the stability testing program, including the coordination of QC stability sample handling including receipt, dispensing, and placement into stability chambers and the sample testing to stability schedule.
- Support compilation of data packages for reference standard qualifications, trend reports, as well as stability study protocols.
- Demonstrating an understanding of analytical chemistry and laboratory procedures and represent the site in regulatory and customer audits.
- Ensuring appropriate technical training is provided for QC personnel.
- Operation of analytical instrumentation including those items specified above, with working knowledge of spectral and chromatographic interpretation and troubleshooting.
- Oversight of analytical method transfers/qualification/validation into the QC laboratory, conducting analytical investigations, and testing using HPLC, GC, IC, GCMS, LCMSMS, KF, DSC, TGA, IR, NMR, Polarimetry, XRPD, UV-Vis, titration and other wet lab procedures.
- Oversight and participation in change control, instrument calibration including IQ/OQ/PQ/PM and troubleshooting, and other projects as assigned.
- Review of analytical results produced by analysis from cGMP testing is required.
- Scheduling and coordinating daily workload for laboratory analysts ensuring efficient use of resources with minimum product turnaround times.
- Working in accordance with current GMPs and regulatory requirements and demonstrates proper laboratory safety and housekeeping practices.
- Use department resources efficiently and work within departmental budget.
Who you are:
- Bachelor’s Degree in Chemistry, Biochemistry orlife science.
- 4+ years of applicable experience (GMP pharmaceutical quality control laboratory experience is preferred)
- Ability to act in a position of leadership.
- Knowledge of Good Manufacturing Practices for pharmaceutical manufacturing (21 CFR 210 & 211) and/or Q7A Good Manufacturing Practice Guidance for API’s.
- Competent knowledge of and ability to use Microsoft Word, Excel and Access.
- Excellent organizational, written and verbal communication and interpersonal skills
- Ability to stand, sit, walk, bend, reach, lift, pull, push, speak, hear, and use hands to operate lab-testing equipment on a regular basis. Specific vision requirements of this job include close vision, color vision, and the ability to adjust focus.
- Using safety glasses/goggles/face shield, latex gloves, lab coat, safety shoes and other required personal protective equipment.
- While performing the duties of this job, this position may be exposed to toxic or caustic chemicals and fumes or airborne particles.
- The noise level in the work environment is moderate.