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Calibration Specialists III-4 at Mallinckrodt Pharmaceuticals in St. Louis, Missouri

Posted in Other 30+ days ago.





Job Description:

Job Title

Calibration Specialists III-4

Requisition

JR000011675 Calibration Specialists III-4 (Open)

Location

Webster Groves (Pharma) - USA038

Additional Locations

St. Louis, MO

Job Description

SUMMARY OF POSITION:

Primarily responsible for maintaining calibration program which includes scheduling calibrations on a monthly basis, performing traceable certifications on in-house standards, obtaining appropriate standards for new instruments, writing and revising new and current SOPs , securely storing historical records of completed calibrations in an efficient manner, coordinating repairs/calibrations with outside vendors, and shipping/receiving of calibration standards sent out for factory certifications. Provide technical support with all R&D/QC laboratory equipment, and assist in laboratory investigations.

ESSENTIAL FUNCTIONS:


  • Maintain systems to assure calibrations are completed on time.

  • Coordinates activities of the calibration specialist

  • Provide backup support for sister sites and as deemed necessary by area supervision.

  • Performs Calibrations and preventive maintenance on a variety of instruments and maintains documentation for completed calibrations

  • Develop and write calibration and use instructions for instrumentation in the Quality laboratories

  • Make minor repairs to equipment and coordinate major repairs with equipment manufacturers and vendors

  • Review completed IQ/OQ/PQ performances as part of change control for services performed by outside vendors

  • Demonstrate ability to troubleshoot most R&D/QC laboratory equipment

  • Knowledge and experience in creation and ownership of Capital Expenditures (CER)

  • Assist in generating change control documents and Standard Operating Procedures.

  • Maintain current knowledge of federal and international regulations regarding analytical chemistry and cGMP's and proactively champion validation initiatives to meet same

  • Follow site HSE policies

  • Assist with establishing & maintaining safe work standards in Lab, and identifying & executing safety improvements and waste minimization opportunities

  • Provide support for customer, FDA or other regulatory agencies for on-site audits


    DEPARTMENT SPECIFIC/NON-ESSENTIAL FUNCTIONS:



  • Takes a lead role in training/mentoring Calibration Specialist II

  • Plans, schedules and arranges own and others activities in accomplishing objectives

  • Follows established procedures using own discretion and judgment as to the specific approach or technique

  • Works with Research and Development (R&D) to maintain calibration schedule and maintenance of assigned equipment within R&D.

  • Develops calibration methods and techniques based on principles of measurement science, technical analysis of measurement issues, accuracy and precision requirements.

  • Serve as designee during Supervisor's absence

MINIMUM REQUIREMENTS

Education:

BS in Chemistry, Chemical Engineering, related science or equivalent combination of education, experience, and competencies.

Experience:

  • Minimum of 5-8 years' experience in Quality Control/ Quality Assurance in a pharmaceutical manufacturing environment. 5+ years' experience and extensive knowledge of wet chemistry, GC/LC, and advanced knowledge of industry principles, practices, standards, theories, and concepts. Proven personnel and project management history. Complete knowledge of pharmaceutical regulations including current GXP, GLP, or GMP requirements.

Preferred Skills/Qualifications:

* ASQ Calibration Technician Certification.

* Detailed oriented with excellent organizational skill.

* Excellent communication and leadership skills.

* Ability to work independently under minimal supervision as well as in a team environment.

* Knowledge of Microsoft Word, Excel, and Access.

* Knowledge and use of measuring devices

* Working knowledge of Six Sigma and/or Lean manufacturing tools.

* Complete understanding and application of principles, concepts, practices, and standards within discipline.

* Ability to lead and influence people. Understanding of basic statistical principles, expert knowledge of validation principles, techniques, and regulatory expectations.

* Knowledge of US and International pharmaceutical manufacturing regulations.

COMPETENCIES:

Action Oriented, Drives for Results, Timely Decision Making, Problem Solving, Customer Focus, Dealing with Ambiguity and Approachability.

ORGANIZATIONAL RELATIONSHIPS/SCOPE:

Has contact with all internal quality and R & D. Has frequent interaction with colleagues at other sites involved with Quality Systems. Need to interact effectively with others throughout the organization in both project leader and/or team member roles. Interact with departmental technicians and investigators.

WORKING CONDITIONS:


  • Occasional travel to other sites to assist with calibration efforts.

  • 60% Laboratory exposure to plant products, solvents and reagents, some of which are hazardous or potent compounds

  • 40% Office environment which includes sitting for long periods of time and computer use

  • Ability to lift 20 kg.

  • Required to work 10-12 hour shifts, the potential for night, weekend, and holiday work depending on the lab


    DISCLAIMER:


    The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required of employees assigned to this position.




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