Quality Assurance

Job Title: Quality Assurance Specialist

Job Description

Manage QC data of multiple programs through external/third party suppliers (CDMO, CTO, etc.). Review raw data from third-party release and stability testing, perform trending for release and stability using applicable software (JMP, iStability, etc.), and 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 and draft and execute quality systems (e.g., OOS/OOT, Deviations, Change Controls, and CAPAs). Additional responsibilities and ad hoc projects as required.

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.
• Perform 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 (e.g., OOS/OOT, Deviations, Change Controls, and CAPAs).
• Handle additional responsibilities and ad hoc projects as required.

Essential Skills

• Quality assurance
• Batch record review
• CAPA management
• Data review
• SOP drafting and review
• Compendial knowledge
• OOS/OOT handling
• Deviations management
• Change Controls
• Audit preparation
• Document control

Additional Skills & Qualifications

• Bachelor's Degree (BS) with 5+ years of 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 systems (Veeva, Mastercontrol, ZenQMS, etc.) and LIMS (Labware, Labvantage, etc.) a plus.
• Excellent communication skills and 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.

Work Environment

This role offers a hybrid work schedule, requiring on-site presence 2 days a week. You will support a close-knit team that currently consists of only 2 members. Given their current 5-project workload, the additional support is crucial.

If interested, please reach out directly to Lindsee Allienello at lallienello @ actalentservices.com.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

• Hiring diverse talent
• Maintaining an inclusive environment through persistent self-reflection
• Building a culture of care, engagement, and recognition with clear outcomes
• Ensuring growth opportunities for our people

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.