Quantimetrix, seeks a Quality Assurance Associate who will write or revise quality documentation, maintain supplier ratings, review and maintain equipment maintenance/calibration logs., assist with raw material qualifications, lab testing. The QA Associate works under the general supervision or as part of a multifunctional team on assignments of varying degrees of complexity to ensure products and processes comply with the Company’s quality system and applicable regulatory requirements.
- Write/revise SOP’s, work instructions and forms related to QA/QC processes.
- Act as back-up to the Quality Review Board (QRB) Coordinator following up on open CAPA’s, NCMR’s as to timeliness of responses, action items and completeness. May be assigned to perform NCMR, CAPA investigations.
- Write and/or revise raw material component specifications.
- Write various studies and validation protocols.
- Review and record test data for consistency and accuracy. Prepare metrics.
- Conduct laboratory testing on incoming, in process and finished materials using laboratory equipment, as required to assist QC department review and maintain calibration records/equipment maintenance records/logs.
- Support document control as to data entry./processing and clerical filling of Documents for ease of retrieval.
- Interface with operations, R&D and Marcom as a team member to accomplish goals. Work as an ambassador and liaison for QA and other departments.
- Cross train in the value assignment process, from coordinating with laboratories to data entry of results and preparing red lined drafts for processing by Marcom.
- Complying with cGMP and laboratory safety practices.
- Perform special projects as assigned by department head or other duties as assigned.
- Bachelor of Science degree with 2+ years’ experience working in a clinical or medical device/IVD laboratory or an FDA regulated quality assurance medical device or pharmaceutical manufacturing environment.
- Excellent communication skills, both verbal and written.
- Ability to write technical reports and/or studies and detail oriented.
- Ability to analyze and present data in a coherent and scientific manner.
- Knowledge of Word, Excel, PowerPoint
Experience working under FDA/ISO regulations.
We value our employees’ time and efforts. In exchange for your hard work and dedication, we offer competitive compensation and medical coverage including health, dental, vision, life and disability insurance. We work to maintain the best possible environment for our employees, where people can learn and grow with the company. We strive to provide a collaborative, creative environment where each person feels encouraged to contribute to our processes, decisions, planning and culture.
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.
Please send your resume to Human Resources at firstname.lastname@example.org or fax to (310) 347-4039.