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QC Stability Specialist

Rockville, MD

Posted: 12/11/2020 Industry: Manufacturing Technician Job Number: JN -122020-12294

Job Description

QC Stability Coordinator

SRG offers flexible staffing solutions with a national presence. We provide contract, contract-to-hire, direct hire and executive search services. SRG utilizes an innovative approach to identify and qualify talent that is unique to the Staffing industry, featuring a cutting-edge platform that allows us to rapidly and precisely match professionals to client requirements. We have a proprietary database of over one million candidates and maintain continuous contact with our qualified talent.
  • Title: QC Stability Coordinator
  • Location: Rockville, MD
  • Industry: Pharmaceutical
  • Hours: 1st shift 8-5pm-remote positions with travel to site as needed
  • Salary: $40.86hr (Paid Weekly - Benefits Available)
  • Employment Type: 6 month Contract (Contract To Hire)
Environment: This client manufactures thousands of pharmaceutical, biologic, consumer health and beauty products utilizing superior and innovative drug delivery technologies to improve their value to patients and consumers. Our customer believes in a Patient First culture putting patients at the center of their work to ensure the safety, reliable supply and optimal performance of our products.

Position Role:
The Quality Control (QC) Stability Specialist is responsible for executing duties to support the stability program for the BWI/Harmans site 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 Specialist must demonstrate technical knowledge, be familiar with basic scientific/regulatory principles, possess initiative, and maintain a strong commitment to quality, compliance and scientific excellence.

Knowledge/Skills Requirements:
  • 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 and ensure timely completion of stability timepoint pulls as per relevant protocols and stability program SOPs.
  • Maintain stability sample inventory and perform stability sample shipments to contract laboratories and/or sample storage vendors.
  • Support and assist with metrics for BWI QC Stability in support of Management Review and investigations.
  • Ensure stability chamber organization, maintenance and support troubleshooting and temperature chart data interpretation.
  • 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.
  • Collaborate with internal departments and teams to resolve quality issues regarding facility, products manufactured and released.
  • Ensure proper documentation (laboratory investigations, out of specifications, deviations, CAPAs), data interpretation/presentation, statistical analysis, and trending.
  • Ensures compliance with cGMP and safety requirements. Participates and leads continuous quality improvements. Participates in quality audits as needed.

Qualifications:
  • BS/BA in a Life Sciences discipline or equivalent experience required.
  • 2 or more years of relevant life science industry experience performing hands on work in a Quality Assurance/Quality Control setting. 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, and related assays.
  • Experience in writing SOPs, handling QC samples and generating or supporting stability protocols and reports.
  • Produce results in a fast-paced and team-oriented environment in-order to meet client deadlines, and under minimal supervision. Ability to learn quickly with a desire for continual development and improvement.
  • Experience with LIMS, Trackwise, and statistical software (.JMP) is preferred.



EOE/ADA


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