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PCI Pharma Services

Laboratory Supervisor, Microbiology

Post Date:Dec 28, 2017Type:Full-Time
Start Date:12/28/2017Salary:
Location:US-IL-Rockford Job Reference:ASSM2064
Skills:


QUALIFICATIONS:


  • Bachelor's Degree in a related field and/or 4-6 years related experience and/or training.

  • Statistical and Advanced Mathematical Skills

  • Advanced Computer Skills: Ability to perform the most complex computer tasks and operate various computer programs.

  • Full Professional Proficiency: Ability to speak, read, and write fluently and accurately on all levels pertinent to professional needs.

  • Very High Reasoning: Ability to define problems, collect data, establish facts, and draw valid conclusions. Be able to interpret an extensive variety of technical instructions in math or diagram form and deal with several abstract/concrete variables.

  • High standard of report writing.


Job Description:

Primary function is to perform microbiological testing of environmental samples, pharmaceutical starting materials, components and finished products to client supplied and Pharmacopoeial methodology, such as USP , , in accordance with regulatory standards with a high level of accuracy and minimal personal error. The ability to successfully interpret and execute technically challenging methodology. Calibration, maintenance and troubleshooting of equipment. Perform method development, validation and method transfers including authoring protocols and final reports. Training of analysts in techniques for which competency has been demonstrated. Authoring on-time investigations, OOS investigations and determination of root cause, including working with internal and external customers to resolve issues. Development and implementation of corrective and preventative actions. Review and approval of technical data. Introduction of new equipment, including authoring and executing URS/IQ/OQ/PQ documentation. Write, review, and revise work practices, and test methods. Project management. Generation of quotations for projects in area of technical expertise. Assist/lead customer audits. Maintain metrics with respect to area of responsibility. Drive on time completion of testing and data correction activities of all personnel performing testing in area of responsibility Allocation of testing to subordinates including collaboration with other department supervisors to ensure on time testing for other services. This role has supervisory responsibilities.


 PRIMARY DUTIES:


  • Receipt and logging of samples into LIMS including setting up new product/test and specifications

  • Works in an efficient manner to a high level of accuracy with minimal personal error in:

  • Daily Monitoring of Temperature Recorder Charts, Collection of environmental samples using aseptic technique, Processing of Microbiological Samples, Spore Strip Testing, Assist with Chemistry Testing as business needs demand i.e. CWS Testing, Incoming Component Testing. Microbial Limits Stability and Release Testing, Cleaning Validations, Method transfer and Method development and validation

  • Preparation and Quality Control Testing of Micro Media

  • Generation and documentation of raw data in accordance with ALCOA principles

  • Ability to interpret different customer method requirements without supervision

  • High level of competency in technically challenging methodology

  • Knowledge of ICH Guidelines which pertain to services trained in

  • Knowledge of USP general chapters which pertain to techniques trained in

  • Training of other analysts in techniques for which expertise has been demonstrated

  • Participate in Product OOS investigations and assist in the determination of root cause

  • Write calibration OOS investigations including RIT's and potential product impact assessments

  • Develop and implementation of corrective and preventative actions

  • Write and investigate deviations from defined procedures

  • Work with internal and external customers to resolve issues associated with deviations and out of specification results.

  • On time investigations including raising extensions prior to the due date if required

  • Attendance at huddles including leading on a rotating basis

  • On time completion of assigned training in ComplianceWire

  • Participate in internal Health and Safety audits including developing actions and follow up

  • Participates in internal and regulatory audits

  • Participate in customer audits by assisting/leading the tour and answering questions

  • Prepares, discuss and present analytical data to internal and external customers and auditors

  • Orders inventory where needed by utilizing the Kanban system/ordering sheet

  • Receives new inventory and puts away in correct location in a timely manner

  • Participates in weekly cleaning of the microbiology laboratory

  • Retains product on completion of testing and raw data upon issuance of analytical report/certificate of analysis

  • Maintains a high level of good housekeeping including ensuring that all dishes are cleaned in a timely manner once analysis is complete. Regularly packs up equipment to be sterilized and puts away in an organized fashion.

  • Maintains a high level of safety and highlights any potential unsafe act immediately to all and works with relevant personnel to prevent further occurrence

  • Ensure that all waste materials/solvents are disposed of in a safe and timely manner.

  • Equipment calibration, troubleshooting and maintenance

  • Training of other analysts in techniques for which expertise has been demonstrated

  • Data review

  • Authors method transfer and validation protocols and reports

  • Mentoring/coaching

  • Initiate change controls

  • Participate in the introduction of new equipment, including authoring and executing URS/IQ/OQ/PQ documentation

  • Project management

  • Provide technical advice to internal and external customers

  • Submit change request in Pilgrim and route in Pilgrim.

  • Review of customer updated methods and the initiation of any transfer/validation activities in accordance with defined procedures

  • Generate quotations for projects in area of technical expertise

  • Drive on time completion of testing and data correction activities of all personnel performing activities

  • Maintain metrics with respect to on time testing for area of responsibility

  • Collaborate with other department supervisors to ensure on time testing for other services

  • Recruitment and selection of personnel

  • Approval of time off requests in line with company policy ensuring that adequate cover is available to maintain service levels

  • Development and recognition of direct reports

  • Holds direct reports accountable for performance and behavior, administering disciplinary action per company policies where required

  • Assess change controls for lab impact and sign in the absence of the Lab Director

  • Monthly invoicing in the absence of the Lab Director.

  • Attendance to work is an essential function of this position

  • Performs other duties as assigned by Manager/Supervisor.




Contact Information
PCI Pharma Services



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