JOB TITLE: Senior Quality AssociateLOCATION: Remote (WA or MA preferred) - candidates based in the following states will be considered: IN, MA, NC, NJ, NH, NM, NY, PA, SC, SD, TX, KY, MS or WA.
SALARY RANGE:$92,000 to $102,000ABOUT THE POSITIONThis is a unique and exciting opportunity to join a growing team of passionate professionals at the forefront of cell therapy and cornea care innovation. As a Senior Quality Associate, you will play a critical role in accomplishing this mission and in staging Aurion Biotech novel cell therapy treatment for successful launch in the United States.
The primary purpose of the Senior Quality Associate is to support the implementation, maintenance, and improvement of the Quality Management System and support Contract Development and Manufacturing Organization (CDMO) and Contract Testing Lab (CTL) management.
KEY RESPONSIBILITIES- Author and review Standard Operating Procedures (SOPs)
- Provide Quality Onboarding training
- Support vendor management activities
- Review/Approve vendor documentation
- Review executed manufacturing records in support of product disposition
- Support computer system validation activities
- Support quality performance/continuous improvement activities
- Assist in compiling metrics for Quality Management Review
- Other duties as assigned
Requirements
QUALIFICATIONS AND EDUCATIONTo perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the education, experience, knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Bachelor's degree Biology, Chemistry or other relevant scientific discipline preferred.
- 4+ years of full-time cGMP Quality Assurance experience.
REQUIRED SKILLS AND ABILITIES - Travel required up to 35%.
- Experience with eQMS (e.g., ACE, TrackWise)
- Working knowledge of current industry practices and standards in an FDA-regulated biotechnology company
- Excellent record keeping and documentation skills
- Strong communication skills, both verbal and written, with the ability to concisely present information in cross-functional settings
- Experience working with CDMOs prefererd
- Proficient use of MS Office products
- Ability to rapidly adapt to changing environment and circumstances requiring flexibility, tolerance, and a great sense of urgency while ensuring that all cGMP and regulatory requirements are met
- Ability to work effectively both independently and with other team members.
Salary Description
$92,000 to $102,000
