Quality Control Supervisor

Salary depends on experience
Posted on 10/16/17
8 - 10 years experience
Biotech/Pharma
Salary depends on experience
Posted on 10/16/17

Job Description

Quality Control Supervisor

Position Summary

The QC Group Supervisor is responsible for supervising QC, Senior QC, and Principal QC Analysts and overseeing scheduling of all analytical functions to support manufacturing and quality agreement necessities for all scale up and commercial operations.  Analysts at this level have demonstrated significant scientific and technical breadth to support analytical test methods in a pharmaceutical manufacturing facility.  They also have demonstrated the ability and desire to supervise, train, coach and mentor other analysts.  Individuals in this roll are very independent, well organized, and self-motivated and are expected to communicate effectively.  Interaction with internal and external stakeholders and regulatory bodies will be commonplace

The Role

  • Supervise and provide day to day direction and support for (three to ten) analysts, potentially across multiple shifts and functions (raw materials, in-process, finished goods, cleaning validations, or “project”).  Will be responsible for annual performance reviews, performance feedback, coaching and any formal “personnel” related items.
  • Exhibit analytical mastery across all testing methodologies in the QC laboratory pertaining to pharmaceutical manufacturing and serve as mentors and coaches for individuals within the QC organization.   Analytical mastery will be exhibited in chromatographic techniques (HPLC, TLC and GC, etc.), in-process/finished product analysis (blend/content uniformity, dissolution, related substances, and potency, etc.) and raw material analysis (flame atomic absorption, polarimetry, loss on drying, heavy metal content and viscosity, etc.).  This is achieved by recognition both inside and outside of Quality as a “go to” individual in all areas of testing.  
  • Coordinate scheduling of laboratory work and procedures to support manufacturing needs, i.e., raw materials, in-process, finished goods, cleaning validation, in process and stability testing along with management directed work.  Effectively communicate work responsibilities and timelines to Associate, QC, and Senior QC Analysts.
  • Communicate effectively and in a timely manner any issues and concerns (timeline, personnel, and operational related) to a QC Manager.
  • Effectively motivate analysts and keep work flow on track to meet or exceed customer’s timelines.
  • Supervise multiple shifts of QC, Senior QC, and Principal QC Analysts.
  • Evaluate and implement new analytical technologies, i.e., computer systems, software, HPLC and GC data systems, instrumentation, and updated compendia methodologies, etc.
  • Able to seamlessly move into role of QC Manager on a periodic basis in the absence of formal management staff or as part of a special project. 
  • Develop and Supervisor training for QC, Senior, and Principal QC Analysts on test methods and SOPs.
  • Write test methods and specification sheets.
  • Assist QC Management Team with customer and FDA audits, and follow-up with responses to observations.
  • Oversee “out of specification” and aberrant lab investigations.
  • Assist with special administration projects and other tasks as needed.
  • Recommend and change SOPs as required.
  • Update and maintain SOP’s relating to the QC department.
  • Review and sign off on analytical data and Certificates of Analysis.
  • Responsible for ensuring that the laboratory operates in a clean, uncluttered, safe, and efficient manner.

The Candidate

  • Bachelors Degree in Chemistry, Biology, Chemical Engineering or Life Sciences (Preferred in Chemistry or Biology) AND 7 to 10 Years in a Quality, Laboratory, Clinical or Chemical Manufacturing role; Masters Degree in Chemistry, Biology, Chemical Engineering or Life Sciences (Preferred in Chemistry or Biology) AND 4 to 8Years in a Quality, Laboratory, Clinical or Chemical Manufacturing role; PhD in Chemistry (Preferred in Analytical Chemistry or Pharmaceutical Sciences) AND 0 to 3 Years in a Quality, Laboratory or Clinical role (including time as a post doc)
  • Prior supervisory experience is preferred, but not required.
  • Mastery with analytical techniques as pertaining to a pharmaceutical manufacturing setting. Analytical mastery will be exhibited in chromatographic techniques (HPLC, TLC and GC, etc.), in-process/finished product analysis (blend/content uniformity, dissolution, related substances, and potency, etc.) and raw material analysis (flame atomic absorption, polarimetry, loss on drying, heavy metal content and viscosity, etc.).  This is achieved by recognition both inside and outside of quality assurance as a “go to” individual in all areas of testing.
  • Ability to work well under pressure with no supervision or direction and maintain efficiency and meet or exceed customer’s deadlines.
  • In-depth understanding of cGMP regulations and FDA/USP/EP/BP/ICH/etc. guidelines.
  • Excellent working knowledge of all SOP’s related to the QC function as well as general safety procedures associated with QC laboratory and pharmaceutical industry.
  • Ability to read and understand MSDS requirements and restrictions.

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