QC Stability Specialist (Temp-to-hire)
Company: Abacus Service Corporation
Location: Rockville
Posted on: June 6, 2021
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Job Description:
Description/Comment:
Duration: 6 months
Please use the QC Phone Screen template, found in the "help "
section of IQN. This is required for all submittals.
- 1st shift 8-5pm
-remote positions with travel to site as needed
Job Description
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.
Paragon Gene Therapy, now a part of Catalent, hires people with a
passion to make a difference. Your expertise, coupled with our
advanced technologies and collaboration with innovative
pharmaceutical, biotech and healthcare companies, will help bring
life-enhancing products to the people you know and love. Your
talents, ideas and passion are essential to our mission; to
develop, manufacture and supply products that help people live
better, healthier lives.
The Role:
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.
The Candidate:
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.
We will identify candidates based on the following:
Leads with Integrity and Respect
Delivers Results
Demonstrates Business Acumen
Fosters Collaboration and Teamwork
Champions Change
Engages and Inspires
Coaches and Develops
Position Benefits:
Join a high growth and fast paced organization with a people
focused culture
Global exposure, defined career path and annual performance review
and feedback process Medical, Dental, Vision and 401KStart Time:
12:00 AM
Hours:
Location:
128 9920 Belward Campus Drive. Rockville 52-1667981 Rockville
MD 20850 United States
Education:
Additional Job Details:
Keywords: Abacus Service Corporation, Rockville , QC Stability Specialist (Temp-to-hire), Other , Rockville, Maryland
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