Job Title: QA Associate

Job Description

The QA Associate Operations of 3rd Party Quality reports to the Sr. Director, 3rd Party U.S. Quality. This position supports our client's commercial business and works closely with Supply Chain, Project Management, Regulatory Affairs, R&D, and external suppliers and partners. The position has no direct reports and collaborates with other Managers, 3rd Party Quality, QA Associates, and Sr. QA Associates.

Responsibilities

• Compilation of stability data for all US Third Party commercial products from different sources (ARs, APRs, and CMOs).
• Generate Excel Spreadsheets with the compiled stability data by product and SKU, documenting process/formulation changes (API qualifications, scale-up/down, and other equipment changes).
• Perform stability data analysis and trending.
• Support the Quality department with the revision of Standard Operating Procedures.
• Keep abreast of industry regulations and cGMP trends. Stay informed of FDA and ICH Guidelines related to GMP (Commercial).
• Perform batch record review and release for Third party manufactured sterile products.
• Review analytical testing results for sterile products for release.
• Initiate and conduct investigations.
• Track metrics for external business partners/CMOs on product releases and rejections.

Essential Skills

• Quality assurance
• Testing
• Batch record review
• FDA guidelines
• Document control
• Pharmaceutical quality
• Stability data management
• SOP revision
• GMP compliance
• Audit and CAPA processes
• Compliance management

Additional Skills & Qualifications

• Bachelor’s degree in chemistry, General Biological/Physical Science, or related science from an accredited college or university
• Minimum of 3 years of experience in Quality in the pharmaceutical industry for sterile products
• Experience in supporting deviations and investigations, especially OOS investigations
• Experience in conducting, writing/reviewing deviations and investigations, root cause analyses, and identifying corrective actions
• Previous experience with Third party / supplier Quality is preferred
• Generic pharmaceutical industry experience is preferred
• Ability to work independently
• Decent skills in all areas of communication and collaboration

Work Environment

While performing the duties of this job, the QA Associate, Operations is required to sit and work at a computer for extended periods of time. The work environment offers flexibility with remote work and fosters a great work culture.

Pay and Benefits

The pay range for this position is $40.00 - $45.00/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 Morristown,NJ.

Application Deadline

This position is anticipated to close on Mar 19, 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.

Salary : $40 - $45