195751 - Quality Engineer
Up to $26.40 DOE
6 months
This Job Order is converted into the Direct Hire Job Order number 196199
Chipton-Ross is seeking a Quality Engineer for an opening in Austin, TX.

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 the 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 in 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.

Experienced working in ISO 9001, 13485, USDA and/or GMP environment. 1-3 years of work experience in Quality Assurance/Quality Systems role. Laboratory experience and/or experience with PCR-based technologies a plus (e.g. manufacturing, QC or R&D). Strong computer skills (Office, Project, Teams, Visio, Word, Excel) and experience in E1, SAP, Agile, TrackWise, and Power BI. Advanced computer skills preferred. Experienced with Quality tools, methodologies, and complaint investigations, including root cause analysis. Experienced working & collaborating effectively with internal and external customers. Experienced in improving site’s Quality Management System and promoting site Quality. Experienced working & collaborating with internal and external customers.

Accreditred Bachelor’s degree in life sciences, engineering, process engineering, chemistry, biotechnology or related sciences

2nd shift 2PM– 10:30 (half hour lunch), first couple weeks for training hours will be 8-4:30 to overlap with the core team

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

Kristie Hardage
420 Culver Boulevard
Playa Del Rey, CA 90293

Phone: (310) 414-7800 x251 or (800) 927-9318 x251

To ensure compliance with President Biden’s September 9, 2021 executive order, the client is implementing a new requirement for U.S.-based employees to either show proof of being fully vaccinated from COVID-19, or have an approved reasonable accommodation (based on a disability/medical condition or sincerely held religious belief) exempting them from the requirement, by December 8, 2021 (timing may vary in some states). Individuals who are unable to meet COVID-19 requirements due to a disability/medical condition or sincerely held religious belief may apply for a reasonable accommodation during the post-offer process. Individuals with approved accommodations will be subject to frequent COVID-19 testing.

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.