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Description
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When you re part of the team at XXX Scientific, you ll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and you ll be supported in achieving your career goals.
Location/Division Specific Information
Life Sciences Group (LSG) - BioProduction Group. Detroit, MI Peptone Manufacturing Site.
How will you make an impact?
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.
What will you do?
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.
How will you get here?
Minimum: Bachelor of Science (BS) Degree in Business or a scientific discipline is. Other relevant credentials or experience may be acceptable.
- 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.
Knowledge, Skills, Abilities
- 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 and carrying heavy items.
At XXX Scientific, each one of our 70,000 plus extraordinary minds has a unique story to tell. Join us and contribute to our singular mission enabling our customers to make the world healthier, cleaner and safer.
- wapay rate to the resource? XXX / hr.
- Is this role temp to perm? Not approved for temp to perm conversion at this point.
- What is the assignment duration? 6 month with the possibility of extending to 12 months.
- Is there a possiblity the assignment could be extended? Yes.
- Position hours and days? 7:30 AM 4:30 PM
- Interview process: Phone or Webex? Number of interviews? One interview with Webex or Teams. It is possible to have more than one interviewer.
- What is the required experience that a candidate must have for consideration? Outlined in the job description submitted in Workday. Strong focus on Document Control, batch record reviews and product releases, Quality System knowledge.
- What are the intangible skills you d like to see? Strong attention to details.
Skill/Experience/EducationQuality Specialist II
Contingent Hourly (CWHR)-TEM.CWHR.A00
Special Needs
Varite Inc
