- 193353 - Qc Associate Iii
- Ward Hill
- Up to $30.00 DOE
- Chipton-Ross is seeking a Quality Specialist III for an opening in Ward Hill, MA.
•Serve as Quality lead/co-lead on several concurrent process improvement projects to ensure identified compliance gaps are closed in a timely manner
•Aid the site QA/RA leadership team with the tracking and progress of improvement activities, hosting routine forum(s) to report out on progress
•Design and develop procedures and supporting documentation coordinating feedback and process review to expeditiously implement these modified systems
•Facilitate review for completed documents supporting the regulatory and quality systems providing insight to GDP to ensure complete, defendable document packages
•Provide expertise and training with the implementation of the system/procedural improvements
•Conduct periodic effectiveness check activities and audits of the systems supporting controlled substance management as directed by the QA/RA leadership team to verify effective system implementation.
•Generate and monitor metrics for the projects in scope to report on system health and to proactively identify opportunities to drive improvements
•This position requires the ability to remain in a seated position using office equipment and computers. Individuals may also have to do some light lifting of supplies and materials from time to time.
•Experience and Confidence independently managing smaller scope site project teams and improvement initiatives, ensuring transparent communication, issue escalation, and issue/solution based approach
•Strong understanding of ISO 9001 or GMP quality standards
•Has strong understanding of QMS elements governing supplier management such as product technical specifications, change control, and quality agreements and inventory control practices
•Strong attention to detail and ability to focus and multi-task in a dynamic regulated environment
•Confident with QMS system ownership in support of manufacturing operations in a regulated environment
•Excellent written, oral communication skills, and quality technical writing skills a must
•Must be computer savvy and have a working knowledge of Microsoft Office and Teams software
•Ability to work independently in a fast-paced, dynamic environment while quickly developing a confidence with issue escalation and reporting
•Demonstrated ability to confidently interact with a variety of levels within the organization as well as with internal customers and suppliers.
•Solid understanding of controlled substance/DEA related regulations and expected controls
•LEAN/Six Sigma certification (i.e. Green or Black Belt)
•Experience with Oracle, SAP, AS/400 ERP systems desirable
•Experience with QMS software
•Process Mapping Software and skills (Visio or equivalent)
•Bachelor’s Degree in Chemistry or Life Science and 7+ years of Quality experience in a GMP Quality function.
Employment will be contingent on clearing a drug screen and background check. Both must clear prior to start date.
11832 Fishing Point Drive, Suite 100
Newport News, VA 23606
Phone: (757) 595-0005 x261 or (877) 244-5418 x261
Candidates responding to this posting must currently possess the eligibility to work in the United States. No third parties please.
Employment will be contingent on candidate clearing pre-employment drug screen and background check.
Chipton-Ross provides equal employment opportunities to all employees and applicants for employment without regard to race, color, creed, religion, national origin, sex (including pregnancy), age, disability, sexual orientation, gender identity and/or expression, protected veteran status, genetic information, or any other characteristic protected by Federal, State or local law. This policy governs all areas of employment at Chipton-Ross, including recruiting, hiring, training, assignment, promotions, compensation, benefits, discipline, and terminations.