- 188588 - Quality Specialist II
- Up to $104.98 DOE
- 3 mos
- Chipton-Ross is seeking a Quality Specialist II for an opening in Cambridge, MA.
The Quality Assurance Specialist II will support the quality systems team in Cambridge, MA. The Specialist will be responsible for evaluating, reviewing, and approving CAPAs or Change Controls. In this role, they will support Compliance and Quality Assurance management in maintaining and improving cGMP quality Systems.
Conduct QA assessments of product specific change controls, quality issues, CAPA, GMP documentation and contributing to multiple project teams as the quality decision maker. Reviews and approves change controls for appropriateness, completeness and alignment with quality, validation and regulatory expectations. Work with functional groups across the site to review and approve quality and technical documentation including: CAPAs, Action Notice (AN), Change Control Requests (CCR), Documentation Change Requests (DCR), effectiveness reviews as well as associated documentation in support of Preventive/Corrective Maintenance, Metrology, Automation Engineering and Validation. Support third party audits, external customers, and Agency inspections as needed and support internal activities concerning any identified nonconformities. May perform archiving duties in support of QA Document Control. Will perform data migration from paper systems to new electronic data systems.
Preferred experience working in 2 or more functional areas. Minimum of 2 years in cGMP Quality Control operations in a fast-paced production environment. Demonstrated ability collaborate across the business. Strong analytical and problem-solving skills; great attention to detail and excellent decision-making process. Demonstrated ability to present ideas persuasively and negotiate effectively. Excellent written and oral communication skills both internal and external.
Accredited Bachelor's degree and 3 years of related work experience or Master’s degree and 1 year of work experience.
Employment will be contingent on clearing a drug screen and background check. Both must clear prior to start date.
420 Culver Boulevard
Playa Del Rey, CA 90293
Phone: (310) 414-7800 x307 or (800) 927-9318 x307
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.