QC Stability Coordinator

Location: Buena, NJ

Job Summary:

The Quality Control Stability Coordinator is responsible for day to day operations related to stability program, as well as additional departmental duties as described below.

Reporting Relationships:  Individual Contributor

Essential Responsibilities:

  • Execute the day to day operations of the stability program for drug product, including stability sample set-down and pull requirements, ensuring a timely, effective and compliant operation to meet regulatory requirements.
  • Log in and delivering stability samples to the appropriate laboratories with the respective specification sheets.
  • Audit/maintain visibility of the cycle time requirements for the stability testing program to ensure that all testing is completed within the required time frame.
  • Ship samples to Outside Testing Laboratories (i.e. AET/Preservative effectiveness testing samples, raw materials, and other samples as needed).
  • Manage the data generated from stability studies.
  • Write and revise stability protocols and complete stability reports.
  • Liaise with the department members as needed to accomplish tasks in a timely manner.
  • Stability data trending and graphing.
  • Ensure that suitable written records and work undertaken are kept in accord with cGMP and company procedures.
  • Other duties as assigned.

Qualifications:

  • Minimum of a high school diploma, BA/BS preferred, with 2 years of experience in a cGMP/regulated environment or equivalent education and experience.
  • Good communications skills and be experienced in Microsoft programs; Word, Excel, and Access.
  • Excellent multi-tasking and organizational skills.
  • Excellent organizational skills.
  • Demonstrated ability to work on multiple projects and meet timelines and detail oriented.
  • Collaborative working style, demonstrates professionalism, cooperation and willingness to support team and company priorities.
  • Well-developed interpersonal skills.¬† Ability to get along with diverse personalities.
  • Good written and oral communication skills.

Physical Demands/Factors:

  • Physical Demands
    • Mobile/Ambulatory
    • Ability to lift, push and pull 25 pounds
    • Sight
  • Environmental
    • Temperature variations
    • Sit and stand for long periods

This job description is not all-inclusive. It acts as a guideline and is subject to change over time. Additional duties may be assigned based on business needs.

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