- 188473 - QA Specialist
- CA-S.Cali-Los Angeles/Orange Counties
- West Hills
- $22 to $25.00 DOE
- 6 Months
- Chipton-Ross is seeking a QA Specialist for an opening in West Hills, CA.
The QA Contractor will assist with maintaining quality assurance programs, procedures and controls, ensuring that finished devices are inspected and/or reviewed to ensure they meet medical device requirements and are of the highest quality standards prior to release for sale. The Product Release Specialist will also be responsible to ensure that the device history records (DHR) are maintained in an organized manner and able to be assembled quickly for audit purposes.
·Perform product inspections as required to ensure conformance to specifications
·Review of production, packaging/labeling and laboratory documents for final product release
·Assemble device history records
·Systematically release finished and semi-finished product based on conformance to established standards
·Scan DHRs and ensure legibility and accuracy of electronic storage
·Participate in Non-Conformance and CAPA investigations and help to develop solutions to system and procedural problems
·Maintain ownership of SOPs and train colleagues on SOPs as needed
Generate, identify, and suggest quality/process improvements
·Writing as well as assist others in writing new or updated operating procedures and/or work instructions
·Assist in document preparation/presentation for regulatory agency visits and Corporate/internal audits.
·Provide real-time support to Product Packaging and Labeling to prevent backorder, non-conforming materials release and adherence to the production schedule.
·Under limited supervision and in accordance with all applicable federal, state and local laws/regulations, the Companies’ policies, procedures and guidelines, The Product Release Specialist will ensure quality and compliance and safety in all their actions.
·Complete all required trainings in a timely manner. Attend GMP training as appropriate for the role. Adhere to strict compliance with procedures applicable to the role. This individual will exercise the highest level of integrity in the tasks performed.
·In a timely and prompt manner, identifies, reports, and seeks correction for deviations noted in the workplace. Practice all behaviors in a safe and environmentally responsible manner.
·A minimum of 0-3 year’s related QA or QC experience in a GMP regulated environment is preferred.
·Previous experience reviewing and releasing batch records is also preferred.
·Excellent analytical, prioritization, multi-tasking and communication is required.
·Strong leadership skills and the ability to work independently without supervision are required.
·This candidate is required to work effectively on cross functional teams.
·The ability to prepare and present written and verbal reports is also preferred.
Accredited Bachelor’s Degree from an accredited higher learning institution is required; Bachelor’s Degree in Life Sciences is preferred.
1st Shift, Monday-Friday 8am to 4pm
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 x340 or (800) 927-9318 x340
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.