Job Title: QA Operations Specialist

***Shift is Tuesday through Friday 2:30pm - 12:30am (4 X 10's)***

Job Description

The QA Operations Specialist supports Quality Assurance lot release and disposition activities, including process observation, batch record review, and completion of lot release documentation. This role also supports Quality Assurance initiatives, such as review of laboratory investigations and deviation investigations.

ResponsibilitiesPerform QA Operations activities, including review of manufacturing batch records and labeling/packaging operations to ensure timely release of cell therapy products.Support quality assurance processes, controls, and batch history files for QA Operations and Lot Disposition.Provide real-time, on-the-floor support for manufacturing production activities to ensure compliance with GMP and GDP quality initiatives, escalating issues as required.Perform and complete investigation and CAPA reports.Track and communicate standard work completion and hurdles.Actively interact with Contract Manufacturing Organizations (CMO) and internal teams to ensure efficient and timely batch release.Maintain a collaborative and professional relationship with CMOs.Release raw materials and inventory.Prepare and organize release documentation for approvals.Support internal audits and regulatory inspections.Essential SkillsBA/BS or equivalent in Biological/Physical/Chemical sciences, engineering, or equivalent focus of study from an accredited university or college.At least 2 years of proficient GMP QA/QC experience.Experience with CAPA's, investigations, and batch record review/release.Experience with use of an electronic QMS (e.g., MasterControl, Veeva).Familiarity with Code of Federal Regulations and International Council for Harmonization Guidelines governing current Good Manufacturing Practices for Pharmaceuticals.Knowledge of GMP, Good Documentation Practices (GDP) and FDA quality systems.Experience supporting manufacturing within a GMP facility, ideally cell/gene therapy.Additional Skills & QualificationsExperience with cell therapy products and/or relevant skills.Work Environment

This person will primarily reside in the office but will also be on the manufacturing floor to ensure processes are followed and to assist with audits, investigations, and operations.

Pay and Benefits

The pay range for this position is $38.00 - $38.00/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 fully onsite position in Philadelphia,PA.

Application Deadline

This position is anticipated to close on Mar 5, 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.

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.