Quality Control Analyst

Job Title: Quality Control AnalystJob Description Manage QC data of multiple programs through external/third party suppliers (CDMO, CTO, etc.). Perform raw data review of third-party release and stability testing data. 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 and execute quality systems such as OOS/OOT, Deviations, Change Controls, and CAPAs. Undertake 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. 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. Essential Skills Quality assurance Batch record CAPA Data review SOPs Compendia OOS/OOT Deviations Change Controls Batch record review Audit Document control Additional Skills & Qualifications 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. Work Environment Hybrid setup, requiring on-site presence 2 days a week. This role will support a close-knit team that currently consists of only 2 members. Given their current 5-project workload, the additional support is crucial. Pay and Benefits The pay range for this position is $57.00 - $61.00/hr. • 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) Workplace Type This is a hybrid position in Boston,MA. Application Deadline This position will be accepting applications until Dec 6, 2024. 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 (%20actalentaccommodation@actalentservices.com) for other accommodation options.