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Parenteral Manufacturing Technical Services - Cook Pharmica

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Job Snapshot
Location:
Bloomington, IN 47403 (map it!Map it! )
Employee Type:
Full-Time
Industry:
Biotechnology
Pharmaceutical
Manages Others:
Not Specified
Job Type:
Biotech
Manufacturing
Pharmaceutical
Education:
4 Year Degree
Experience:
Not Specified
Travel:
None
Post Date:
11/7/2009
Contact Information
Ref ID:
KC10377
Description PURPOSE, OBJECTIVES, FUNCTIONS:

  • To support the technical transfer process, investigations, and batch record generation for CGMP manufacturing and to partner with internal and external clients to support and design manufacturing processes.

    PRINCIPAL DUTIES AND RESPONSIBILITIES:
  • Plan and participate in manufacturing site audits (Technical and/or CGMP) as required
  • Support technical transfer in conjunction with the development laboratory, manufacturing, and quality assurance
  • Provide support for generation of electronic records with support from recipe authors
  • Support investigations and recommend corrective/preventive actions for ongoing manufacturing processes

    Additional responsibilities:

  • Research new technologies and procedures to improve operations
  • Assist operations team with training and implementation of changes to manufacturing processes

    AUTHORITIES

  • Initiate deviations; work with Quality to investigate and resolve reports; implement corrective actions
  • Identify potential hazards either safety or ergonomic

    EMPLOYMENT REQUIREMENTS:

  • 4-6 years experience in manufacturing or a commensurate level of experience with related products
  • Bachelor’s degree in life sciences, engineering, or other applicable discipline or equivalent industry experiences
  • Requires signing a confidentiality and a non-compete agreement

    POSITION QUALIFICATIONS:

  • Must be able to manage multiple tasks and/or priorities and easily adapt to changing situations
  • Experience with Microsoft Project
  • Demonstrated ability to work cross functionally
  • Knowledge of bio-pharmaceutical regulatory and CGMP requirements
  • Excellent problem solving and investigational skills
  • Excellent organization skills, self-motivation, and ability to work independently
  • Knowledge of computer systems, electronic records, electronic data generation recording, trending and evaluation
  • Possess strong oral and communication skills, and presentation skills
  • Strong ability to multi-task

    ACCOUNTABILITY:

  • Responsible for ensuring the master production schedule is current and accurate on a daily basis
  • Responsible for compliance to federal CGMP requirements
  • Responsible for compliance of Corporate Code of Conduct
  • Responsible for compliance to company’s Quality Policy Manual
  • Responsible for compliance with company’s safety policies
  • Responsible for knowing and adhering to policies and procedures in the company’s Employee Handbook
  • Responsible for training compliance on all job related SOP’s

    PHYSICAL REQUIREMENTS AND ENVIRONMENTAL CONDITIONS:

  • Personal protective equipment including safety glasses, lab coat, gloves, specialized clothing including laboratory scrubs (pants and shirt) and appropriate shoes may be required in areas associated with this position
  • Potential limited exposure to hazardous chemicals while in manufacturing environment
  • Physically capable of standing for 6 hours, stooping, kneeling, climbing
  • Physically capable of pushing/pulling totes on floor jacks
  • Must be able to lift and move 50 lbs.

    We are proud to be an EEO/AA employer M/F/D/V. We maintain a drug-free workplace and perform pre-employment substance abuse testing.

    • Requirements Edu-4 year degree

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