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LifeScience Logistics

Sampling Dispensing Supervisor

LifeScience Logistics, Brownsburg, Indiana, United States, 46112

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Sampling Dispensing Supervisor

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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

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

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

NO AGENCIES PLEASE *

Seniority Level

Mid‑Senior level

Employment Type

Full‑time

Job Function

Other

Industries

Transportation, Logistics, Supply Chain and Storage

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