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Quality Control Supervisor

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:

Basic Qualifications:

  • Bachelor’s Degree in Chemistry, Biochemistry orlife science.

Preferred Qualifications:

  •  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
  • Detail-oriented.
  • 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.

 

 

Job Requisition ID:  208794
Location:  Madison
Career Level:  D - Professional (4-9 years)
Working time model:  full-time

Careers during Covid-19
Thank you for visiting our careers website, we are always looking for curious minds to join our teams. We understand how much the world is being impacted by the Covid-19 crisis and we want to assure you that your safety is very important to us. To ensure that everyone’s health is protected, instead of a standard face-to-face interview, it is likely that you will be offered alternative digital interview options.

US Disclosure
The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law.  This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.

North America Disclosure
The Company is committed to accessibility in its workplaces, including during the job application process. Applicants who may require accommodation during the application process should speak with our HR Services team at 855 444 5678 from 8:00am to 5:30pm ET Monday through Friday.

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