What are the responsibilities and job description for the Sampling Dispensing Supervisor position at LifeScience Logistics?
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
- 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 PowerPoint
- NO AGENCIES PLEASE *