QA Complaints Specialist

Description:

• Ensure Product Quality Complaint system and procedures are compliant with regulatory requirements, industry standard, and company guidance.
• Manage receipt, investigation and closure of product complaints to ensure adherence to established timelines.
• Investigate complaints and document according to templates and procedures...(.this process would include heavy document review of manufacturing documentation, release documentation, laboratory documentation, deviation investigations, etc.)
• Work with and manage third-party Contract Manufacturers as necessary for applicable investigation activities and/or testing.
• Identify root cause of the complaint and facilitate identification and implementation of corrective and preventive actions as appropriate.
• Perform follow-up communication with the customer/reporter to acquire information that may be required to effectively investigate the customer complaint.
• Support internal and external cGMP audits and regulatory agency inspections and completion of inspection commitments.
• Assist in the handling and processing of field alert reports to FDA as deemed necessary.
• Support operations and quality management initiatives and objectives.

Position is heavy on review and processing of complaint data and files. Full investigations are less of the role but they need to be capable of performing.

Skills:

Gmp, pharmaceutical manufacturing, quality investigation, cGMP, Deviation, complaint management

Top Skills Details:

Gmp,pharmaceutical manufacturing,quality investigation

Additional Skills & Qualifications:

• Bachelor’s Degree in science or a Pharmaceutical-related field, demonstrated or equivalent experience could work but not preferred
• Minimum of 3 - 4 years experience with knowledge and understanding of regulatory compliance / cGMP requirements for pharmaceutical manufacturing processes / operations.
• 1 year of finished pharmaceutical experience highly desired (think final packaged product usable by a patient)
• Demonstrated experience and skills in conducting and documenting quality investigations related to pharmaceutical manufacturing processes.
• Analytical and critical mind and technical writing skills required
• Could consider someone with QC investigations experience looking to transfer to QA

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.