- 191314 - QA Specialist
- Remote Work
- Up to $25.00 DOE
- 7 months
- Chipton-Ross is seeking a QA Specialist for an opening in Remote, CA.
Review validation projects, protocols, and reports in support of equipment and process validation.
Write and review protocols and reports.
Review IQ/OQ protocols and reports.
Assist in Risk Assessment exercises in support of validation activities.
Collaborate with R&D, Product Development Manager, Technical Operations, and Operations to ensure successful process development and technical transfers.
Coordinate validation activities/reviews in support of assigned validation projects working closely Subject Matter Experts.
Recommend approval or failure of validation studies.
Maintain knowledge and comprehensive understanding of relevant Medical Device regulations and current interpretations affecting equipment, product and process validation.
Act as a resource to other departments for product and process knowledge.
Able to work independently, with guidance from the Quality Assurance team.
Ability to learn new products and technology.
Able to successfully lead a project involving a peer group.
Lead and/or participate in product related team meetings and/or performance reviews, as needed.
Assist with QA department functions as needed. (Specific duties may vary and will be documented in department records, job assignments and/or project action items).
Perform computer operations for data entry and provide tracing/trending reports.
Additional support of routine QA department standard operating procedures (SOPs) is also expected when necessary.
Exhibits a high level of quality (right the first time), integrity (do what you say you are going to do), and cross functional behavior (always stay above the line).
3-5 years relevant experience in Quality regulated environment
Detailed knowledge of ISO and GMP regulations which govern a medical device and diagnostics manufacturing
Able to create presentations, work with spreadsheets, prepare reports and write procedures utilizing MS Word, Excel and PowerPoint software applications.
Consistently demonstrated validation proficiency, with knowledge of equipment qualification (IQ/OQ/PQ), process validation, and computer/automation systems.
Good analytical skills, with an ability to use scientific knowledge and statistical methods to identify root causes of process and product failures.
Strong project management and organizational skills.
Demonstrated technical skills in process validation & concepts with an emphasis on implementation.
Excellent verbal and written communication skills.
Previous experience in problem solving methodology.
Possess a continuous process improvement mindset with the ability to effectively lead and manage change.
Bachelor’s degree in Biology, Chemistry, or other similar Life Science field.
Employment will be contingent on clearing a drug screen and background check. Both must clear prior to start date.
6926 Rivers Ave
North Charleston, SC 29406
Phone: (843) 554-5800 x186 or (800) 927-9318 x186
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.