Sampling Dispensing Supervisor

• Direct, mentor, train, and coach responsible associates and maintain an optimized organizational structure
• Supervise all activities of the department to meet client expected timelines for service
• Coordinate, train and/or perform all EM testing (viable/nonviable air sampling, contact surfaces) and ship applicable samples to 3rd party lab for analysis at determined intervals
• Collects, prepares and presents all EM data reports and metrics on a monthly basis
• Establishes and maintains department procedures and specifications ensuring processes are accurate and meet current regulatory requirements
• Ensure quality, validation and applicable regulatory procedures are current, relevant, and properly followed
• Key point of contact with QA and Clients in determining root cause of discrepancies, EM actions and help develop corrective actions and verification activities
• Utilize Quality tools such as Six Sigma, FMEAs, Risk Assessments and /or statistical software to facilitate tracking/trending activities, identify potential issues/risks, and data driven decisions
• Support Manager in developing the monthly and annual balancing of departmental budget through which all department activities and initiatives are funded
• Assure calibrated systems and equipment are current and maintained
• Conduct gap analyses, benchmarking, and process improvement initiatives
• Other duties as assigned

• Bachelor of Science (BS) degree in Microbiology or related scientific field (preferred)
• 1-3 years’ experience working in a regulated microbiology lab
• Minimum of 2 years supervision experience within a pharmaceutical laboratory or equivalent
• Successfully engage in highly complex problem-solving for which there may be little precedent

• Deftly navigate through Quality and Warehouse Management Systems with training – CQ, Tecsys Elite, WEBCTRL, SOMs
• Microsoft Office skills:
  Outlook, Excel, PowerPoint and Word
• Expert with FDA cGMPs per 21 CFR 210/211
• Expert with EM standards per USP, ISO 14644-1, EU GMP Annex 1
• Ability to track, trend and present EM data
• Excellent verbal and written communication skills

• Demonstrated skills and practice of Six Sigma/statistics and process capability/FMEA
• Must be able to successfully pass all preliminary employment requirements (i.e., background check and drug screen)
• Must have a valid driver’s license
• Ability to manage multiple projects and work effectively in cross-functional teams with internal and external customers
• Ability to work effectively and manage risk in a fast-paced environment with ambiguity and change
• Interpersonal skills to include listening, coaching, and communicating with integrity
• Managing conflict and using data to drive decisions, even when unpopular

• Work is light to medium in nature with frequent walking to perform assigned tasks
• Must be able to safely lift 25-50 lbs.
• Must be able to communicate clearly with clients and employees
• Must be able to read at a distance, close to the eyes, and at arm’s length, with or without correction

• Activities occur within a typical office environment
• 20% of time is spent in a cleanroom setting

• Equipment:
  Laptop computer, cell phone, fax machine, copier, and desk phone
• Systems:
  Outlook, Excel, Word and Power Point

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
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