Quality Assurance/Quality Control Associate
We are looking for a Quality Assurance/Quality Control Associate to write or revise quality documentation, assist with raw material qualifications, perform process and final quality inspections and lab testing. You will assist in conducting product extensions. As the Quality Associate, you will be expected to work under 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.
Responsibilities:
- Write/revise SOP’s, work instructions, forms, component specifications, etc. related to QA/QC processes
- Write and/or revise raw material component specifications
- Write and at times execute product extension and other various studies.
- Review and record test data for consistency and accuracy.
- Conduct laboratory testing on incoming, in process and finished materials using laboratory equipment, as required.
- Record and maintain temperature data for various equipment.
- Learn the applicable QC functions as related to the new ERP system.
- 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, as to data entry and review. learn the coordination with outside value assignment laboratories.
- Complying with cGMP and laboratory safety practices
- Perform special projects as assigned by department head or other duties as assigned
- Employee will contribute to a positive work environment
- Assist in maintaining Quantimetrix Corporation quality system
Qualifications:
- Bachelor of Science degree in clinical, biological, or chemical sciences
- 2+ years’ experience working in a clinical or medical device/IVD laboratory or an FDA regulated quality assurance medical device or pharmaceutical manufacturing environment
- Ability to write technical reports and/or studies
- Ability to analyze and present data in a coherent and scientific manner
- Excellent communication skills (both verbal and written)
- Basic use of Excel spreadsheets and statistics
- Detail oriented
- Experience working under FDA/ISO regulations
Best-in-Class Benefits and Perks:
We value our employees’ time and efforts. Our commitment to your success is enhanced by competitive compensation of $30-35/hour, depending on experience, and an extensive benefits package including:
- Comprehensive health coverage: Medical, dental, and vision insurance provided
- Robust retirement planning: 401(k) plan available with employer matching
- Financial security: Life and disability insurance for added protection
- Flexible financial options: Health savings and flexible spending accounts offered
- Well-being and work-life balance: Paid time off, flexible schedule, and remote work choices provided
Plus, we work to maintain the best environment for our employees, where people can learn and grow with the company. We strive to provide a collaborative, creative environment where everyone feels encouraged to contribute to our processes, decisions, planning, and culture.
Join us on the journey of excellence and innovation. Apply now and be a part of something extraordinary!
Ready to take the lead in our manufacturing revolution? If you're excited to drive change, inspire a team, and make a lasting impact, we want to hear from you!
We are committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person’s race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation, or any characteristic protected under applicable law.
