Quality Assurance Specialist

Seeking 1 Quality Assurance Specialist

HYBRID ROLE- MUST BE ONISTE IN PARSIPPANY, NJ

Description:

• •Provide Quality oversight to biologics Contract Manufacturing Organization (CMO) operations including but not limited to review/approval of CMO batch records, disposition, deviations, CAPAs, change controls, and inspection management.

• Routinely review and approve Certificates of Assurance (CoA) and Certificates of Compliance (CoC), routine manufacturing, environmental monitoring and quality control data for in-process and finished products.

• Exercises judgment within well-defined and established procedures and practices to determine appropriate action with minimal supervision.

• Perform Quality Assurance activities to ensure compliance with internal processes and procedures and applicable US and international regulatory requirements in support of current Good Manufacturing Practices (cGMP) operations.

• Accountable for extracting, consolidating, and analyzing data within a specific area of concentration.

• Uses standard processes to execute analyses but given latitude in determining the optimal way to present results.

• Demonstrates an ability to communicate effectively with peers in CMO Organization

Additional Skills & Qualifications:

Basic Qualifications:

6+ years of relevant experience in a GMP environment related field and a BS OR 4+ years of relevant experience and a MS.

Open to no degree if significant BRR experience (i.e. 6+ years)

Prior experience in pharmaceutical industry is preferred.

Preferred experience working with CMOs and biologics

Experience Level:

Expert Level

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.