- 183198 - Sr QA Technician
- CA-Bay Area
- Up to $25.00 DOE
- 5 Months
- Chipton-Ross is seeking a Sr. QA Technician for an opening in Pleasanton, CA.
As a Sr QA Technician, you will help provide Quality support to ensure the Pleasanton site meets all of its customer needs. You can help make an impact by providing site QA support including document control management activities, creating and reviewing (COA) Certificates of Analysis, (COC) Certificates of Conformance, and (COO) Certificate of Origins. The role will also provide help with audit hosting & logistics, identifying and implementing improvements to current QA documents, collection and reporting on Quality dept metrics, preparing Quality presentations, and creating new Quality documents and work instructions.
• Data mine and sort through QC & MFG results, systems, and documentation to create COAs, COCs, COOs upon customer requests and inquiries
• Create, modify and draft Quality procedures as tasked; implement using Document Management Systems (i.e. Agile)
• Support site Training Administrator by updating training requirements of employees using Learning Management Systems, includes update training plans and databases
• Assist in external or internal audits, provide backroom audit support locating files, making copies, contacting subject matter experts, etc.
• Must have familiarity with Root Cause Investigations, Non-conformance handling, other Quality tools and ISO13485 and 9001 requirements
• Work with different work centers and colleagues to pull and collect data, update logs, establish weekly metrics
• Maintain Quality dept metrics and report out key accomplishments and escalations to Quality team leader
• Must be able to respond to customer inquiries timely, effectively and provide customer centric service
• Promote and implement improvements on day-to-day tasks, documents, or processes with team leader
• Participate in departmental projects and improvement initiatives, i.e. streamline SOPs and processes to make daily tasks more efficient
• Support continuous improvements through participation within the Site’s PPI Program
• Prepare and disseminate clearly written personal or dept communications to customers
• Serve as backup for Document Control Administrator, learn document change order (DCO) process
• Draft and revise written relevant Standard Operating Procedures (SOPs) and submit procedural changes as needed or directed
• Perform other duties to support the quality department as assigned.
• Experienced working in ISO 9001, 13485 and/or GMP environment
• 2+ years of work experience in Quality roles (QA, QS, QC, etc)
• Strong computer skills (Office, Project, Teams, Visio, Word, Excel, Adobe)
• Experience with SAP, Agile, Access, Track Wise
• Experienced working and responding to external customers
• Must be self-motivated, organized, detail oriented, and have ability to complete tasks and assignment
• Must be able to learn quickly, various systems and databases
• Must be comfortable work with tight timelines and under minimal supervision
• Must be able to work independently, and work with a diverse team.
• Solid organizational skills with ability to balance work activities and competing priorities and the ability to manage time effectively and prioritize work;
• Highly energetic, positive attitude and works well under stress but strong attention to details
• Excellent communication and interpersonal skills with the ability to interact with all kinds of customers, especially in written responses and must have strong customer facing skills
• High level of reading comprehension skills;
• Results oriented and multi-tasking skills are a must
Certificates in life sciences, engineering, chemistry, biotechnology or related sciences is highly recommended
Accredited High School Diploma/GED, AA degree is plus
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 x307 or (800) 927-9318 x307
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.