Duties and Responsibilities:

• To perform QC test as required.
• Supervising the review of laboratory data (both internal and external) and the closeout of

  deviations.

• Scheduling of testing - coordinated with the other departments delivering samples to ensure timely delivery of results.
• Supervision of all testing techniques
• Responsible for ensuring that all personnel involved in testing are trained in basic cGMP

  training and are getting routine updates in cGMP information and training

• Author and review Change Controls, Deviations/Investigation as well as Test Methods,

  Specifications and SOPs

• Responsible for data and logbook review Customer and regulatory agency interaction as required
• Work interdepartmentally to enhance communications at all levels and ensure that work

  orders, preventative maintenance, compliance and documentation issues are resolved

• Evaluations of vendors via vendor audits, comprehensive testing and review of quality

  performance

• Perform report writing (Example: Deviations/Investigations/Trending) Involved in equipment qualification
• Perform annual performance evaluations of all direct reports
• Provide continued coaching and developing of subordinates to help them meet both their

  career and personal development goals and to ensure a cohesive, productive and highly motivated team

• Any other duties as assigned by your Manager

Specific Areas of Responsibility:

1. Microbiology/EM Area:

• Supervision of all microbiological and Environmental Monitoring techniques including

  QC testing of environmental, raw materials, in-process and final product samples. QC testing includes but is not limited to: Total particulates, Air viable, Surface viable, Bioburden, Endotoxin, Growth Promotion, Biological Indicator Check Testing and Microorganism Identifications.

• Responsible for tracking and review of virus and mycoplasma testing for all products (as required).
• Responsible for tracking and review of QC cell banking activities.

Advancement to next level based on evaluation of the following:

• Demonstrated leadership within and outside direct shift responsibility.
• Make companywide contributions, relating to expenditures, budget, efficiency, etc…
• Individual should demonstrate responsible attitude appropriate to a corporate environment.
• Demonstrate solid leadership skills as well as team building and strengthening skills.
• Demonstrate solid cGMP knowledge.
• Demonstrated ability to communicate effectively in professional manner with customers.
• Performing current duties and responsibilities for a minimum of 2-3 years

Education / Experience

• Degree/Diploma in a relevant Science field or Equivalent
• 6-8 years of relevant work experience preferably Lab experience in a biotech or medically related field
• Well verse in cGMP regulations
• Knowledge area specific responsibilities
• Good problem solving and analytical skills
• Good communication skills
• Strong leadership skills

Competencies

• Decision Making
• Planning/Organizing
• Effective Communication
• Personal Orientation
• Teamwork
  

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