P2P2 — Developing Professional
QA Specialist II
Review and approve SOPs, conduct and document internal audits, lead investigations for moderate deviations, and provide training and guidance to P1 staff.
What this level means
Early-career professional; developing skills, handles routine tasks with some independence
- Scope
- Defined deliverables / small features
- Autonomy
- General supervision; reviewed at milestones
- Complexity
- Some non-routine problems; applies established patterns
- Impact
- Own and immediate-team deliverables
- Decision rights
- Routine technical choices within guidance
- Leadership
- May guide interns
- Typical experience
- 1–3 yrs
What you'd do
- Review and approve SOPs, protocols and batch records for compliance.
- Independently conduct and document internal audits; participate in mock inspections.
- Lead investigations for moderate deviations/OSOs; propose corrective actions.
- Coordinate with R&D or production teams to implement QA requirements and changes.
- Provide training and guidance to P1 staff on QA procedures.
- Approve SOPs and protocols.
- Conduct and document audits.
- Lead moderate deviation investigations.
Skills, knowledge & tools
- SOP review
- Audit documentation
- Moderate deviation investigation
- Training provision
- QA coordination
- SOP compliance
- Audit techniques
- Deviation management
- Training methodologies
- QA implementation
- Communication
- Analytical thinking
- Accountability
- Integrity
What good looks like
- 2–5 years of QA/QC/R&D experience in biotech/pharma
- Demonstrated proficiency in performing QA tasks (audits, documentation review, investigations)
Common titles
QA Specialist II
Where it sits & what it pays
O*NET / SOC: 51-0000 — Production Occupations(inferred · under review)
Market-pay benchmarks for this family × level are coming — JobFrame anchors pay to the family/level structure rather than the raw title.