- 194128 - Quality Specialist II
- CA-S.Cali-Los Angeles/Orange Counties
- West Hills
- $25 to $35.00 DOE
- 6 mos
- Chipton-Ross is seeking a Quality Specialist II for an opening in West Hills, CA.
Quality Specialist II, Post Market Surveillance (PMS) and Stability will provide support in preparation of data analysis, reporting, trending, and documentation review, coordination of complaint and lot qualification data, device history reviews and review and closure of certain categories of complaints. It requires regulatory assessment capability along with MDR/Vigilance reporting. The Post Market Surveillance Specialist may also review and monitor data and document quality, as requested by the manager.
Coordinates and performs various stability testing in accordance with stability protocols. Ensures stability samples are available and placed in stability chambers at the appropriate time frames to meet the requirements of the stability protocol. Ensures stability samples are pulled at the appropriate time frames to meet requirements of the stability protocol. Analyzes stability test data utilizing the department stability software program. Assists Risk and PMS manager with summarizing stability data for submission into the final stability report. Ensures testing and data analysis is completed in a timely manner to meet business and regulatory deadlines. Identifies Out of Specification results and notifies manager in a timely manner. Notifies manager immediately when adverse stability data trends are identified. Ensures stability chambers are maintained and calibrated according to internal and external quality and regulatory requirements
Six years of experience in a Quality regulated environment. Able to create presentations, work with spreadsheets, prepare reports and write procedures utilizing MS Word, Excel and PowerPoint software applications. Good procedural writing skills a plus. Exercise independent discretion and judgment in execution of duties. Plan and organize oneself in a consistent manner. Be a self-starter with the ability to positively motivate others in a cooperative fashion. Establish and maintain effective working relationships with other staff members. Effectively communicate both orally and in writing to management, customers and regulatory personnel. Maintain confidentiality of sensitive laboratory information; perform computer operations for data entry.
Background in diagnostics.
Detailed knowledge of ISO 13485 and GMP regulations which govern a medical device and diagnostics manufacturing. Knowledge of complaint handling requirements. Tracking and trending tools and reporting techniques.
Accredited Bachelor’s degree in Biological Sciences or a related field.
Day/Hours of Shift: 8:00 – 5:00
Employment will be contingent on clearing a drug screen and background check. Both must clear prior to start date.
6926 Rivers Ave
North Charleston, SC 29406
Phone: (843) 554-5800 x246 or (800) 927-9318 x246
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.