- 189367 - Quality Specialist I
- CA-Central California
- 6 mos
- Chipton-Ross is seeking a Quality Specialist I for an opening in Fremont, CA.
Responsible for maintaining and updating Quality Systems (includes internal audits, customer complaints, corrective actions, non-conformances, product and process improvements) and Document Control (including, but not limited to standard operating procedures, specifications, quality manual, certificates, calibration reports, document change orders, product insert sheets) Participate in internal audit activities. Provide Quality support for new products. Check and verify that change orders are accurate, properly cross reference all affected documents, and meets requirements for compliance with external customers, internal documentation and cGMP documentation practices. Processes complaints and non-conformances and monitors for trends. Verify that corrective actions are on schedule and support completion, initiate and implement process improvements for the documentation system. Assist in preparation for Quality Management System reviews. Manages periodic review processes and supports the generation of monthly document control metrics. Provides additional support and assistance on tasks and projects with minimal direction from management.
Thorough knowledge of 21CFR820 and ISO 13485
Proficient in Microsoft Word and Excel; familiarity with Access, PowerPoint, and SmartSheets is a plus. Ability to maintain confidential information, to meet deadlines, manage priorities, accuracy and attention to detail are critical. Ability to transfer subject matter expertise and understanding to other employees and/or internal customers is required regarding why work is performed the way it is and how it impacts the broader organization. Demonstrates strong understanding of Quality Systems fundamentals, Electronic Document Management Systems (EDMS) , knowledge of the process, effects, and the relationship between the document change process and products, and understanding of current Medical Device industry and applicable regulations including 21 CFR, ISO, GxP. Strong organizational skill to handle multiple projects. Strong written and verbal communication skills and ability to work with a wide range of personnel with varying technical skills and Quality understanding. Must exhibit professionalism, be an advocate for quality and self-motivated
Accredited BS Degree and/or minimum 2+ years' experience in biotechnology, medical devices, or pharma.
Shift: M-F, 8-5pm (flexible)
Remote: Must be local, can work partially from home after training. May need to work onsite 2 days a week at the most.
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.