Job Listing Description

Quality Specialist II

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

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 document control processing and management, releasing raw material and finished good product, conducting batch record reviews and final product verifications, support quality improvement initiatives, maintain quality presence on the production floor and overall responsibility towards maintenance of the quality system in controlled manufacturing environment.

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. Responsible for management of documentation life cycle including storage, archival, removal, destruction of documentation as required per standard procedure: Destruction and archival of records. Creating a plan/process for storing records off-site. Create a process for logging records in and out of Document Control. Create a process for labeling stored records. Categorize records to enhance organization and prevent mixing. Create a map of file locations. Maintains and coordinates documentation as required by the manufacturing facility such as Batch Records, Logbooks, Calibration Records…etc, and other documentation activities as required. 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. 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. 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.

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. Excellent verbal and written communication skills and ability to collaborate across different levels of the organization. Knowledge of cGMP regulations and ISO standards. xcellent 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 and carrying heavy items.

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

7:30 AM – 4:30 PM

Job Number: 192634
Job Location: Detroit, MI
Rate: $DOE
Duration: 6 mos
Input Date: 07/16/2021
Attention: Tyler Harrell
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

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