Sampling Dispensing Supervisor

Life Science Logistics•Brownsburg, IN

About The Position

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

Requirements

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
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

Nice To Haves

Bachelor of Science (BS) degree in Microbiology or related scientific field (preferred)

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