QC Stability Coordinator
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- Title: QC Stability Coordinator
- Location: Harmans, MD
- Industry: Pharmaceutical
- Hours: 1st shift 8-5pm-remote positions with travel to site as needed
- Salary: $28.84hr (Paid Weekly - Benefits Available)
- Employment Type: 6 month Contract
This individual is responsible for executing duties to support the stability program for the 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
SKILLS & TECHNICAL EXPERTISE:
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
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
Ability to succeed in a team-oriented environment under very dynamic conditions