QC Stability Coordinator

QC Stability Coordinator

18 Mar 2024
Maryland, Hanover, 21113 Hanover USA

QC Stability Coordinator

Vacancy expired!



Hello

,



This is

Shyam Chavan and I am

Talent Acquisition Specialist - Lead from Experis - The

Manpower Group. I am recruiting for an immediate job opportunity with one of our direct client. If Interested, Please share your updated resume at

Job Title: QC Stability Coordinator

Duration: 12 months

Location: Harman's, MD 21077

Description


  • This individual is responsible for executing duties to support the stability program for the Catalent CGT-Maryland sites in compliance with internal SOPs and ICH guidelines.

  • This includes writing stability protocol and reports (interim and final). The individual will perform stability timepoint pulls and sample testing as needed.

  • The Quality Control Stability Coordinator must demonstrate technical knowledge, be familiar with basic scientific/regulatory principles, possess initiative, and maintain a strong commitment to quality, compliance and scientific excellence. Execution of duties for the Maryland stability program and related stability studies

  • Support and assist with generation of stability SOPs, protocols and reports (interim / final). Assist with and support stability protocol, report and SOP revisions as needed

  • Perform timely completion of stability timepoint pulls as per relevant protocols and stability program SOPs

  • Maintain stability sample inventory and related metrics for current stability studies

  • Support and assist with metrics for QC Stability in support of Management Review and investigations

  • Perform stability sample shipments to contract laboratories and/or sample storage vendors

  • Maintain stability chamber care, maintenance and support troubleshooting and temperature chart data interpretation

  • Assist with and support stability data trending in accordance with stability program SOPs and ICH guidelines

  • Perform QC testing as needed to support product release and stability studies

  • Work closely with Manufacturing, Quality Control, Quality Assurance and Regulatory staff to resolve quality issues regarding the stability program.

  • Document writing (laboratory investigations, out of specifications, deviations, CAPAs), data interpretation/presentation, statistical analysis, and trending

  • Ensures compliance with cGMP and safety requirements within the QC laboratory Participates and carries out continuous quality improvements in the QC laboratory

  • Participates in project specific, system, client, and vendor audits Maintains QC analytical laboratories and facilities in an audit ready status at all times.

  • Support and participate in training on applicable SOPs, regulatory requirements and quality initiatives

  • Strong focus on responsiveness, ability to multi-task, attention to detail, effective problem-solving skills, consistent follow-up and ability to make timely and sound decisions (Quality and Business). Must be able to prioritize.

  • Must possess excellent communication and writing skills, patience, professionalism and ability to effectively interact with staff and management alike (transversely collaborative) across functional groups and levels Ability to work within a team setting as well as independently


Other duties as assigned


  • Execute activities associated with the Stability Program and related SOPs

  • Analyze data and complete reports with attention to detail

  • Experience with LIMS, Trackwise and statistical software (.JMP) is preferred

  • Apply scientific and regulatory principles in order to solve operations, as well as routine tasks, in the QC department

  • Produce results in a fast-paced environment in order to meet client deadlines, and under minimal supervision

  • Builds credibility within the group by performing high quality work

  • Familiarity with Good Manufacturing Practices (GMPs)

  • Effectively communicates results of own work through presentations, discussions, and documentation


Education/previous Experience:


  • Bachelor in a Life Sciences discipline or equivalent experience is a minimum requirement

  • 2 or more years of relevant experience and at least 1 year of stability program experience in GMP regulated laboratory preferred

  • Basic knowledge relevant to stability studies, ICH guidelines related to stability, QC methods used for protein chemistry, molecular biology and microbiological testing.

  • Experience within the biologic, pharmaceutical, or medical device industry performing direct hands-on work in a Quality Assurance/QC function with a basic familiarity of general GMP practices

  • Experience in writing SOPs, handling QC samples and generating or supporting stability protocols and reports

  • Broad experience with biochemistry, biological and microbiological assay support, as well as generating the documentation that supports such work.


Shyam Chavan

Talent Acquisition Specialist

Experis CORE

100 Manpower Place

| Milwaukee, WI 53212

Email ID:

Desk # - Ext - 7156


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Job Details

  • ID
    JC11173492
  • State
  • City
  • Job type
    Contract
  • Salary
    N/A
  • Hiring Company
    Experis
  • Date
    2021-03-18
  • Deadline
    2021-05-17
  • Category

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