Associate QA Specialist-Temp
Position Summary:
Hybrid- Either San Carlos, CA or Austin, TX. office location.
Under direct supervision, the Associate Quality Assurance Specialist supports the Quality team in executing daily quality operations, including documentation review, audit support, and administrative oversight of quality system processes. The individual will gain exposure to regulations such as FDA, ISO13485, CLIA, and CAP and will expand their knowledge through hands-on duties, training, and mentoring.
Primary Responsibilities:
• Collect and trend quality metrics under supervision
• Provide administrative support for CAPAs, Deviations, SCARs, Complaints, and NCRs
• Support document review, qualification record tracking, and audit preparation
• Assist with scheduling and logistics for internal audits
• May serve as scribe or support during internal and external audits
• Help maintain training records and employee credential tracking
• Coordinate with IT for user access to eQMS and training systems
• Perform other duties as assigned
Education & Qualification:
• Associate’s degree, certificate, or B.S./B.A. in Life Sciences or related field; equivalent experience accepted
• 0–2 years of work experience in a biotech or regulated environment preferred
Knowledge, Skills, and Abilities:
• Strong computer skills (MS Office, Google Suite)
• Good technical writing and communication skills
• Organized, detail-oriented, self-motivated, and eager to learn
• Ability to multitask and work independently in a fast-paced environment
Physical Demands & Work Environment:
• Duties are typically performed in an office setting
• Must be able to sit or stand for long periods
• Travel: No ☒
The pay range is listed and actual compensation packages are based on a wide array of factors unique to each candidate, including but not limited to skill set, years & depth of experience, certifications and specific office location. This may differ in other locations due to cost of labor considerations.
Remote USA
$35—$40 USD