Job Description
The Quality Assurance Specialist plays a critical role in supporting externally manufactured pharmaceutical and biopharmaceutical products. This position involves reviewing and writing quality systems documentation while collaborating with internal and external counterparts at the Contract Manufacturing Organization (CMO) and cross-functional team members. The role also requires appropriate escalation of issues to senior management.
ResponsibilitiesReview stability reports, evaluate data, and manage records.Approve CMO documentation for batch production and review batch records, addressing discrepancies and escalating issues to management.Input and route quality agreements.Manage quality records, including deviations, change controls, and CAPAs.Monitor cold-chain transportation for both qualification and routine purposes.Conduct annual product quality review assessments and author certain sections.Write quality systems documents and work within Master Control for authoring, reviewing, routing, and approving.Maintain regular communication with internal partners to ensure timely manufacture and resolution of quality issues.Support continuous improvement projects related to quality and Quality Management Systems (QMS).Essential SkillsExperience in quality assurance and knowledge of FDA regulations.Proficiency in CAPA, change control, and QMS, including deviations and change controls.Training in supplier qualification and document management systems.Preferred experience in cGMP and pharmaceutical industry practices.Ability to conduct audits and manage batch records and document control.Additional Skills & QualificationsBachelor’s degree in a scientific discipline.Preferred 2-5 years’ experience in quality roles with increasing responsibility.Direct experience working with quality systems, including deviations, change controls, training, supplier qualification, and document management systems.Understanding of cGMP requirements for pharmaceutical manufacturing, specifically CFR 210/211.Experience with sterile injectable pharmaceuticals is preferred.Work Environment
The position offers a hybrid work environment, requiring attendance at the Hazelwood, MO office 1 or 2 days per week as needed. The work schedule is Monday through Friday, with flexible start times between 7:00-9:00 AM and 8-hour shifts. No overtime is required.
Pay and BenefitsThe pay range for this position is $38.00 - $50.00/hr.
Eligibility requirements apply to some benefits and may depend on your job
classification and length of employment. Benefits are subject to change and may be
subject to specific elections, plan, or program terms. If eligible, the benefits
available for this temporary role may include the following:
• 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 Hazelwood,MO.
Application Deadline
This position is anticipated to close on Jun 20, 2025.
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.
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 due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.