Experis, a ManpowerGroup company has an exciting contract opportunity for an QC Stability Coordinator. This position is for one of our key clients, a global biopharmaceutical company that is engaged in the discovery, development and manufacturer of healthcare products.
Please find below Job Description:
Job Role: QC Stability Coordinator
Location: Harmans, MD 21077
Duration: 6+ months (High Possibility of Extension).
Top Skills: QC, GMP, Manufacturing
Description: This individual is responsible for executing duties to support the stability program for the Company's 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
- Minimum supervision required on day-to-day activities and accomplished tasks
- Exhibits commitment to timelines and good time management in the execution of duties.
- Positive and professional attitude toward work along with a willingness to cooperate with co-workers and supervisors in order to contribute to a project team.
- Timeliness and accuracy in completion of projects and paperwork.
- Offers suggestions for correcting problems and for improving QC operations.
- Exercises good judgment in dealing with operational/technical problems.
- Understands the theory and rationale behind tasks being performed.
- 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.
Primary Recruiter: Saira Hasan
Recruiter Phone Number:
414-666-8462 Ext - 7168
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