203466 - Quality Specialist II
CA-S.Cali-Los Angeles/Orange Counties
West Hills
$25 to $35.00 DOE
12 months

Chipton-Ross is seeking a Quality Specialist II for a contract opportunity in West Hills, CA.

This position is 100% onsite.

Coordinates and performs various stability testing in accordance with stability protocols.
o Ensures stability samples are available and placed in stability chambers at the appropriate time frames to meet the requirements of the stability protocol.
o Ensures stability samples are pulled at the appropriate time frames to meet requirements of the stability protocol.
o Analyzes stability test data utilizing the department stability software program.
o Assists Risk and PMS manager with summarizing stability data for submission into the final stability report.
o Ensures testing and data analysis is completed in a timely manner to meet business and regulatory deadlines.
o Identifies Out of Specification results and notifies manager in a timely manner.
o Notifies manager immediately when adverse stability data trends are identified.
o 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.
o 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.
o Exercise independent discretion and judgment in execution of duties.
o Plan and organize oneself in a consistent manner.
o Be a self-starter with the ability to positively motivate others in a cooperative fashion.
o Establish and maintain effective working relationships with other staff members.
o Effectively communicate both orally and in writing to management, customers and regulatory personnel.
o Maintain confidentiality of sensitive laboratory information; perform computer operations for data entry.

Detailed knowledge of ISO 13485 and GMP regulations which govern a medical device and diagnostics manufacturing. Knowledge of complaint handling requirements.
o Tracking and trending tools and reporting techniques.

Accredited Bachelor's degree in Biological Sciences or a related field.

1st Shift

Employment will be contingent on clearing a drug screen and background check. Both must clear prior to start date.

Amy Shook
420 Culver Boulevard
Playa Del Rey, CA 90293

Phone: (310) 414-7800 x206 or (800) 927-9318 x206

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.