Quality Control Analyst

Actalent • Boston, MA

391d • $118,560 - $126,880 • Hybrid

About The Position

The Quality Control Analyst at Actalent is responsible for managing quality control data across multiple programs, primarily through external suppliers. This role involves reviewing raw data from third-party testing, conducting data trending, drafting and reviewing quality documentation, and collaborating with Analytical Development on method qualification and validation. The position supports quality systems and undertakes additional responsibilities as needed, contributing to the overall quality assurance processes within the organization.

Requirements

• BS with 5+ years industry experience required.
• 3+ years of quality control related experience.
• Experience working in a QC lab environment with knowledge of international and national regulations and guidelines related to product testing.
• Familiarity with ICH analytical and stability requirements.
• Experience with quality management systems (Veeva, Mastercontrol, ZenQMS, etc.) and LIMS (Labware, Labvantage, etc.) a plus.
• Excellent communication skills and the ability to build key networks and business relationships across all levels of the business.
• Experience in method transfer, validation, and qualification a plus.
• Lab experience in release and stability testing a plus.
• Experience drafting, reviewing, and performing data verification of regulatory filing sections.

Nice To Haves

• Experience with quality management systems (Veeva, Mastercontrol, ZenQMS, etc.) and LIMS (Labware, Labvantage, etc.) a plus.
• Experience in method transfer, validation, and qualification a plus.
• Lab experience in release and stability testing a plus.

Responsibilities

• Manage QC data of multiple programs through external/third party suppliers (CDMO, CTO, etc.).
• Review raw data from third-party release and stability testing.
• Conduct trending for release and stability using applicable software (JMP, iStability, etc.).
• Draft and review QC documentation, including Stability Protocols and Reports, SOPs, Material Specifications, CoA templates, and other quality documents.
• Collaborate with Analytical Development to support method qualification, fit for use, validation, and method transfer activities.
• Support the reference standard program.
• Draft and execute quality systems such as OOS/OOT, Deviations, Change Controls, and CAPAs.
• Undertake additional responsibilities and ad hoc projects as required.

Benefits

• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Administrative and Support Services
• Education Level: Bachelor's degree
• Number of Employees: 10,001+ employees