Job Title: Quality Specialist I – III
Description: Full Time, Non-Exempt
Department: Quality Assurance
Reports to: Quality Manager/Director
Location: San Diego, CA
Job Description No.: 622-2-29
Biomatrica’s mission is to contribute to the development of better diagnostics and therapies, with improved access for patients globally. Based in San Diego, Biomatrica is privately held. The company is founded on a compound library and intellectual property which it deploys to collect, protect and store biomaterials subject to degradation, including nucleic acids, proteins, and cells. The applications are broad and include diagnostics, biobanking, research, and industrial. The company recently introduced an innovative line of CE- IVD marked sample collection products for: (1) cell-free DNA and tumor cells in blood for pre-natal testing and liquid biopsy, (2) DNA in saliva for medical and personal genomics, (3) RNA and DNA for gene expression testing.
The Sr. Quality Assurance Specialist is responsible for ensuring compliance with applicable domestic and international standards and regulations through audits and systematic maintenance of effective quality systems. This individual ensures that deadlines are met on time and within budget and provides Quality interface with other departments and business or marketing partners. This individual works independently and exercises judgment within the defined procedures and
practices to determine appropriate actions.
Essential Duties and Responsibilities
- Demonstrates working knowledge of Quality Control, Manufacturing and Inventory processes.
- Serves as QA interface with limited responsibilities to other departments.
- Reviews Customer Notifications and prepares, approves & submits data packages for external customers.
- Supports internal and/or external audits in compliance with ISO 13485 and 21CFR820 requirements.
- Participates in 3rd Party Audits from regulatory bodies including the FDA, notified bodies and business partners.
- Assists in developing quality systems & make recommendations for improvements to existing Quality systems.
- Approves compliance assessments & interfaces with other departments and business partners for complaints, investigations, etc.
- Prepares appropriate Agendas and meeting minutes.
- Monitors the progress of items on the meeting Agendas and reports progress, as appropriate.
- Chairs meetings & represents QA as an extended core team member on Core team and cross-functional special project teams.
- May conduct new employee quality system or procedural training and develops and maintains department training programs.
- Conducts complex technical troubleshooting activities & investigation analysis.
- Develops, analyzes, trends, maintains & reports department metrics, as needed.
- Reviews and assesses change control, validation, and qualification documents, as applicable.
- Assists in decision making at meetings for recalls, MDRs, field corrections &/or market recalls.
- Requires minimal BA or BS in a biological or chemical science; management; or equivalent.
- 5-8 years related quality experience.
- Quality certification (from American Society for Quality or equivalent) is a plus.
- Working understanding of QSR & ISO requirements
- Advanced knowledge of QC, Manufacturing & Inventory processes
- Working knowledge of Microsoft Word, Excel, Power Point and related functions including the formulation of graphs.
- Organizational skills, attention to detail and ability to prioritize in a fast paced environment is essential.
- Must demonstrate initiative, independence, balanced assertiveness, flexibility and team orientation.
- Depending on the area of assignment, directly related experience or a combination of directly related education and experience and/or competencies may be considered in place of the stated requirements. Example: If a job level requires a Bachelor’s degree plus 4 years of experience, an equivalency could include 8 years of experience, an Associate’s degree with 6 years of experience, or a Master’s degree with 2 years of experience.
- May occasionally lift, carry, push, pull or otherwise manipulate objects up to 10 pounds in weight, and/or lift, carry, push, pull or otherwise manipulate objects of a negligible weight frequently or continuously.
- Sedentary work involves sitting the majority of time. Jobs are sedentary if walking and standing are required only occasionally.
If you are looking for a position with growth potential in an exciting industry, please forward your resume with a cover letter to: email@example.com and note “Quality Specialist I – III” in the subject line of your e- mail. Please send attachments in MS Word or PDF format only with “your name-resume” and “your name- cover letter” as the document name. Relocation reimbursement is not available for this position.
Please note: The information contained herein is not intended to be an all-inclusive list of the duties and responsibilities of the job, nor are they intended to be an all-inclusive list of the skills and abilities required to do the job. Management may, at its discretion, assign or reassign duties and responsibilities to this job at any time. The duties and responsibilities in this job description may be subject to change at any time due to reasonable accommodation or other reasons.