Job Listing Description

Quality Specialist II

Description:
Chipton-Ross is seeking a Quality Specialist II for an opening in Detroit, MI.

OBJECTIVE:
As a Quality Specialist II, you will have the opportunity to support a life science manufacturing facility in Detroit with specialized Quality Assurance services. You will make an impact by supporting various quality assurance activities including releasing raw material and finished good product, conducting batch record reviews and final product verifications, document control processing, support quality improvement initiatives, maintain quality presence on the production floor and overall responsibility towards maintenance of the quality system in controlled manufacturing environment.

RESPONSIBILITIES:
Responsible for the release and disposition of material, batch record review, and QC data review and disposition. Conduct final product labeling reviews and verifications at times of release. Responsible for management of documentation life cycle including storage, archival, removal, destruction of documentation as required per standard procedure. Maintains and coordinates documentation as required by the manufacturing facility such as Batch Records, Logbooks, Calibration Records…etc, and other documentation activities as required. Support initiation of Standard Operating Procedures (SOPs) and other related site’s-controlled records. Ensure compliance of the Quality systems at the Detroit site to cGMP and ISO 13485:2016 requirements. Maintain responsibility and ownership of the documentation management system facilitating revisions and creation of documents. Perform administration duties of the Document Control and Change Order activities. Ensure compliance of the Learning Management System to site’s procedures and standards. Tracking of training records within the site. Support all internal and external audits and ensure compliance of the audit program with site and standards. Lead/Support Quality (Gemba) walk-throughs to enhance compliance. Manage Stability Program and performs review of stability test data. Enhance traceability of the Deviation (planned) with product releases.

REQUIREMENTS:
A minimum of 2-3 years prior experience in a Quality Assurance role. Preferably, in a cGMP Pharmaceutical/Biotech/or Life Science site. Strong knowledge of ISO 13485 standards and FDA cGMP regulations (i.e 21 CFR 820). Prior experience with batch records reviews and releases of raw material and finished good products. Prior experience with an electronic Quality Management system software utilized for processing of documentation creation. Lean Sigma Green Belt certified a plus. ASQ certification is a plus. Excellent verbal and written communication skills and ability to collaborate across different levels of the organization. Knowledge of cGMP regulations and ISO standards. Excellent organization skills with strong attention to details. Ability to multitask efficiently to support production demand. Computer skills: knowledge of Microsoft Office applications (Work, Excel and PowerPoint) is a must. The job may require standing for long periods of time.

EDUATION:
Accredited Bachelor of Science (BS) Degree in Business or a scientific discipline is. Other relevant credentials or experience may be acceptable.

WORK HOURS:
Full-Time

Day shift - 8 hours - Starting no later than 7:30am
 
Job Number: 191012
Job Location: Detroit, MI
Rate: Up to $30.00 DOE
Duration: 6 mos
Input Date: 06/02/2021
Firm Name: CHIPTON ROSS
Attention: Billy James
Address: 420 CULVER BLVD
City, State: PLAYA DEL REY, CA 90293
Phone: 310/414-7800 X286
800 Phone: 800/927-9318
Fax Phone: 310/414-7808
Email: bjames@chiptonross.com
Website: www.chiptonross.com

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