Sampling and Dispensing Supervisor

RESPONSIBILITIES:
• 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

QUALIFICATIONS AND JOB SPECIFICATIONS:
• 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
TECHNICAL EXPERTISE:
• 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
ADDITIONAL EMPLOYMENT REQUIREMENTS
• 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
PHYSICAL/MENTAL/VISUAL DEMANDS
• 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
WORKING CONDITIONS
• Activities occur within a typical office environment
• 20% of time is spent in a cleanroom setting
EQUIPMENT OPERATED
• Equipment: Laptop computer, cell phone, fax machine, copier, and desk phone
• Systems: Outlook, Excel, Word and PowerPoint

LifeScience Logistics is an equal opportunity employer that takes affirmative action to employ and advance in employment individuals without regard to race, color, religion, sex, national origin, protected veteran status, disability, sexual orientation or gender identity.
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.