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Research operations, compliance, and oversight; Analyzing and interpreting data

Quality Assurance Specialist

What this job does:

Ensures that drugs, biologics, and medical devices are manufactured and tested according to strict safety and regulatory standards. Spends the day reviewing documentation, conducting internal audits, investigating quality issues, and training lab and manufacturing staff on proper procedures. Serves as a guardian of product quality and data integrity, preventing contaminated or ineffective products from reaching patients.

This job is similar to these lab/research tasks:

Maintaining detailed lab notebooks, following and developing SOPs, troubleshooting failed experiments, training others in lab techniques, managing shared equipment, conducting peer review of data

Typical starting salary range

$75k to $130k

Salary estimate represented as 25th to 75th percentile. Gathered from recent job postings, Glassdoor.com, and Salary.com

Daily task breakdown

- Document review and approval: SOPs, batch records, deviations, CAPAs (30%)
- Auditing: internal audits, vendor audits, inspection readiness (25%)
- Quality event investigation and root cause analysis (20%)
- Training, coaching, and cross-functional communication (15%)
- Other: regulatory monitoring, QMS maintenance, metrics and reporting (10%)

Skills you'll use in this job:

cGMP/cGLP/GxP regulatory knowledge; quality management systems (QMS); root cause analysis and CAPA management; internal and external auditing; technical writing and document control; risk assessment (FMEA); attention to detail; communication and training skills; FDA/ISO regulatory frameworks; electronic quality systems (Veeva, TrackWise)

Talk about these PhD skills in your resume and interview:

Talk about your experience with experimental rigor and data integrity - the exact mindset needed for QA. Highlight maintaining detailed lab notebooks, following and developing SOPs and protocols, troubleshooting failed experiments (directly analogous to deviation investigations and root cause analysis), and training others in lab techniques. If you managed shared equipment, maintained lab safety standards, or conducted peer review of others' data, emphasize these as directly translatable quality oversight skills.

Alternative job titles to search:

QA Analyst; Quality Assurance Associate; Senior Quality Assurance Specialist; Quality Assurance Scientist; Quality Compliance Specialist; Quality Systems Specialist; GxP Compliance Specialist; Quality Engineer (Life Sciences); QA Manager

*Note:

-Job titles are inconsistent between companies. Try various keywords.
-PhDs tend to undershoot seniority level. Target higher than you think.

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