Senior QC Investigator - Deviations & Change Controls

Actalent; Apex (NC); On-site; USD 62,000 - 76,000; Full time

Benefits offered by this job

Medical, dental & vision

401(k) Retirement Plan

Life Insurance

Job summary

Actalent is seeking a Quality Control Senior Associate for our on-site GMP QC laboratory in Apex, NC. The role supports startup and ongoing QC operations with a focus on deviations, CAPAs, change controls, and QMS documentation.

The position requires strong investigative leadership and cross-functional collaboration in a fast-paced environment. The ideal candidate has 3+ years in GMP biotech/pharma, experience with Veeva Vault or similar systems, and meticulous written communication, with

Qualifications

• 3+ years industry experience in a GMP-regulated biotech/pharma environment.
• Experience writing and owning quality records (deviations, CAPAs, change controls).
• Knowledge of equipment qualification and QC laboratory operations.
• Familiarity with FDA and GMP requirements for QC labs.

Responsibilities

• Lead and own deviation investigations with root cause analysis and CAPA implementation.
• Manage and close quality records including deviations, CAPAs, and change controls.
• Author and own change control records in the DQMS Quality System.
• Lead cross-functional investigation teams and drive timely completions.
• Collect and report metrics for deviations, CAPAs, and change controls.

Skills

GMP-regulated Biotech experiência

Quality systems knowledge

Deviation investigations

CAPA & Change controls

Investigation leadership

Cross-functional collaboration

Written communication

Education

Doctorate degree

Masters degree + 2 years experience

Bachelors degree + 4 years experience

Associates degree + 8 years experience

HS diploma + 10 years experience

Tools

Veeva Vault Quality Systems

DQMS

Job description

Actalent is seeking a Quality Control Senior Associate for our on-site GMP QC laboratory in Apex, NC. The role supports startup and ongoing QC operations with a focus on deviations, CAPAs, change controls, and QMS documentation.

The position requires strong investigative leadership and cross-functional collaboration in a fast-paced environment. The ideal candidate has 3+ years in GMP biotech/pharma, experience with Veeva Vault or similar systems, and meticulous written communication, with