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14 days old

QC Stability Coordinator

Kelly Services
Harmans, MD 21077
Kelly Services has been providing outstanding employment opportunities to the most talented individuals in the marketplace. We are proud to offer a long-term temporary opportunity to work as a **QC Stability Coordinator** at a prestigious Fortune 500 company working in **Harmans, MD.**





**Important information:** This position is recruited for by a remote Kelly office, not your local Kelly branch. To be considered for this position, you must use the Submit Resume button to submit your resumes. If you have questions about the position, you may contact the recruiter for this position ( Brooke.Schoen@kellyservices.com ) however your resume must be received via the Submit Resume button included within.





**Job Title: QC Stability Coordinator**





**Pay: $28.84 per hour**





Remote positions with travel to site as needed





Initial 12-month contract




**Description**



This individual is responsible for executing duties to support the stability program for the 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



Ability to succeed in a team-oriented environment under very dynamic conditions







**We invite you to bookmark our Web site and encourage you to review it regularly for new opportunities worldwide:** www.kellyservices.com at http://www.kellyservices.com/ **.**





**_Kelly Services is a U.S.-based Fortune 500 company. With our global network of branch locations, we are uniquely positioned to provide our customers with international staffing support and our employees with diverse assignments around the world._**





**Kelly Services is an Equal Opportunity Employer**








**Why Kelly** **** **?**



Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.


**About Kelly** ****



At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. at https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm

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Posted: 2021-01-08 Expires: 2021-02-08

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QC Stability Coordinator

Kelly Services
Harmans, MD 21077

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