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Supervisor, Quality Control

Your Role:

 

This position is for a first shift Supervisor role at the Verona facility. The primary responsibilities of the Supervisor, Quality Control position are to provide management of the Quality Control department which is responsible for method validation/qualification, testing and timely release of raw material, in-process, intermediate, final product, and stability samples associated with cGMP manufacturing. This position is responsible for supporting efforts to ensure the laboratory is compliant with regulatory requirements including oversight of the training program for QC personnel, maintenance and calibration of instrumentation, reference standard inventory program, and all supportive efforts undertaken in the testing of cGMP materials. Direct management, engagement, and development of Quality Control personnel are also primary responsibilities.

 

This position includes the 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. Experience with writing technical reports is required. Additional responsibilities may include oversight and participation in change control, instrument calibration including IQ/OQ/PQ/PM and troubleshooting, cleaning verification/validation program, stability program, environmental monitoring program, supplier qualification program, and other projects as assigned. Review of analytical results produced by analysis from cGMP testing is required. The Quality Control Supervisor position, like all positions at SAFC, will require a willingness to contribute to the overall success of the company by assisting in many areas beyond specific job duties. 

  • Demonstrates the ability to provide leadership and organize departmental staff to meet deadlines without compromising quality.
  • Demonstrates an understanding of analytical chemistry and laboratory procedures.
  • Ensures appropriate technical training is provided for QC personnel. 
  • May perform routine and non-routine tests as required. Operation of analytical instrumentation including those items specified above, with working knowledge of spectral and chromatographic interpretation and troubleshooting.
  • Schedules and coordinates daily work load for laboratory analysts ensuring efficient use of resources with minimum product turnaround times.
  • Works in accordance with current GMPs and regulatory requirements, and demonstrates proper laboratory safety and housekeeping practices.
  • Uses department resources efficiently and works within departmental budget.
  • Identifies areas for improvement and takes action to undertake them through leadership and delegation to other members of the department.
  • Maintains accurate and concise records.  Technical report writing.
  • Environmental conditions:  Work near moving mechanical parts.  Occasionally required to wear appropriate protective gear (hard hats, lab coats, safety glasses/goggles, chemical resistant sleeves, gloves, safety shoes) and other personal protective equipment “PPE” to protect from toxic or corrosive chemicals in the forms of liquids, solids, vapors, or airborne particles.  Must be willing to work with highly potent/hazardous materials requiring the use of proper PPE, which could include half/full face respirators.
  • Physical requirements:  Regularly required to sit, stand, walk, reach above the shoulder, stoop, kneel, twist, crouch, or crawl for extended periods of time.  Must occasionally lift and/or move up to 25 pounds unassisted and be capable of pushing and pulling heavy materials to complete assignments.  May be required to lift more poundage with assistance.  Must be able to speak, hear, taste, and smell.  Specific vision requirements include close vision, distance vision, color vision, peripheral vision, depth vision, and the ability to adjust focus.  Regularly use phones, computers, computer monitors, and all office/laboratory equipment.  Required to type at a computer keyboard and can read CRTs/computer monitors.

 

Who You Are:

 

Basic Qualifications

  • BS/BA in Chemistry or related science

Preferred Qualifications:

  • At least 5 years of applicable experience (cGMP pharmaceutical quality control laboratory experience is preferred)
  • Ability to act in a position of leadership and work in analytical testing labs with hazardous/toxic chemicals.
  • Knowledge of Good Manufacturing Practices for pharmaceutical manufacturing (21 CFR 210 & 211) and/or Q7A Good Manufacturing Practice Guidance for API’s preferred.
  • Excellent organizational, written and verbal communication and interpersonal skills.
  • Knowledge and understanding of organic analytical chemistry are preferred.

RSREMD

Job Requisition ID:  193796
Location:  Verona
Career Level:  D - Professional (4-9 years)
Working time model:  full-time

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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