Quality Assurance Specialist

Description:

Main responsibility is review and release of executed batch records coming out of contract mfg / packaging vendors. Primarily packaging. These >100pages BRR.

Perform review/release of executed batch records.

Perform review/approval of various packaging documents as it applies to CXO (Contract Manufacturing /Packaging Organization.

Interface with CXO in support of routine manufacturing/packaging activities.

Performs a variety of activities to ensure compliance with applicable regulatory requirements.

Adhere to programs and processes to ensure high quality products and compliance with current Good Manufacturing Practices (GMPs).

Reviews manufacturing/packaging control data for in process and finished products.

Review and provide information relevant to manufacturing/packaging of product at the CXO for the writing of the annual product reviews.

May conduct or serve as a lead/coordinator of investigations and corrective and preventive action (CAPA) recommendations related to manufactured/packaged products.

Works with cross-functional teams during new product start-ups and product launches and identifies checkpoints for new products and processes.

Normally receives very little instruction on routine work, general instructions on new assignments.

Skills:

Quality assurance, Gmp, Batch record, Capa, Batch record review

Additional Skills & Qualifications:

Specific product knowledge: Pharma products in general, finished goods - not API.

This is a packaging review - a lot of common sense or dealing with complex biologics. Reviewing labeling.

Demonstrates working knowledge of current Good Manufacturing Practices (GMPs) and/or Good Laboratory Practices (GLPs).

Demonstrates working knowledge of quality assurance systems, methods and procedures.

Demonstrates knowledge of FDA / EMEA standards and quality systems.

Demonstrates basic knowledge of six sigma, LEAN and root cause analysis tools used for identifying and correcting deviations.

Demonstrates audit and investigation skills, and report writing skills.

Demonstrates good verbal, written, and interpersonal communication skills.

Demonstrates working proficiency in Microsoft Office applications.

Education and Experience

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

2+ years of relevant experience and a MS.

Prior experience in pharmaceutical industry is preferred.

Experience Level:

Intermediate 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.