- 189361 - Sr QA Technician
- Up to $22.00 DOE
- 12 months
- Chipton-Ross is seeking a Sr QA Technician for an opening in Austin, TX.
Perform daily quality assessments to uncover errors or deficiencies and assure quality and compliance as required by site procedures and cGMP and IVD. Daily interaction with personnel to assist with troubleshooting, documentation corrections/notes, and guidance. Fosters quality culture by aiding personnel in understanding application of policies and controls. Ensures escalation of deviation events to the appropriate area and quality management. Performs quality review and approval of procedures, training documents, and forms of moderate to high complexity. Performs quality review and approval of deviation and change control of low to moderate complexity. Participates as the quality assurance representative in root cause analysis to support deviation investigations of low to moderate complexity. Performs quality batch record review. Aids in identification of continuous improvement opportunities; Participates in practical process improvement initiatives. Perform Batch Record Review and help with Product Release. Archival of manufacturing and QC records. Sample Retain management. Recommend improvements to processes and procedures; may help revise procedures. Perform other duties to support the Quality department as assigned. Duties will include complaint handling, will work with cross functional department on complaint cases for investigations, root cause analysis, and corrections/corrective actions to ensure proper documentation and closure, provide trending and escalations as appropriate. Participate in internal audits per ISO 13485 and 9001 requirements and ensure site audit readiness. Support internal Quality activities concerning any identified nonconformities. Participate in departmental projects and improvement initiatives through the site’s PPI Program and partner with other groups to continuously improve. Prepare clearly written business communications, including audit reports, gap assessments, validations, etc. Generate and fulfill customer request for COAs, COCs, COOs. Perform other duties to support the quality and regulatory department as assigned. Creating problem reports for nonconforming raw material. Ensuring discrepancies are thoroughly identified, defined and properly assessed. Interacting with interdepartmental contacts on change and discrepancy assessment, resolution, and quality approval. Providing timely information to Operation. Update and meet metrics. Identifying opportunities for continuous improvement of the Quality Systems and participate on implementation. Maintain calibrated tools and equipment. Be able to communicate technical issues and inspection results orally and in writing. Ability to work independently and as part of the QA Team. Sense of urgency with completion of projects and tasks. Serves as a backup for other Quality positions as needed
Ability to gather data, analyze & troubleshoot process issues, equipment problems along with production leadership. Self-driven, demonstrated ownership & responsibility; Ability to lead, support & motivate a team. Technical Writing experience preferred. A minimum of 2 years’ experience in Quality Assurance or Quality Control, Operations/Manufacturing or equivalent
Previous experience in pharmaceutical industry; preferably GMP/IVD experience strongly preferred, experience in other regulated environments a plus (i.e. ISO 9001). Professional certifications (ex: CQA, ASQ) and training (Six Sigma) are a plus
SAP, Trackwise, AGILE experience are a plus
Accredited Bachelor’s degree, preferably in technology, engineering or science related field
Accredited Associates degree, minimum in technology, engineering or science related field.
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 x290 or (800) 927-9318 x290
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.