Quality Assurance Specialist

1 week ago

Ledgewood, New Jersey, United States Actalent Full time

About the Role: We are seeking a highly skilled Quality Assurance Complaints Specialist to join our team in Ledgewood, NJ. This is a 2-month renewable contract position that requires strong analytical and communication skills.

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Job Summary: As a Quality Assurance Complaints Specialist, you will be responsible for ensuring manufacturing procedures are followed in accordance with Standard Operating Procedures (SOPs), current Good Manufacturing Practices (cGMP), Food and Drug Administration (FDA) standards and batch record specifications. You will support operational needs and activities to successfully achieve quality goals and complaints metrics.

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Main Responsibilities: The successful candidate will handle product complaints received from customer service department, initiate and process notifications as required by applicable SOPs, interact with customer service and customers to acquire additional information, evaluate complaints for regulatory reportability and create and submit reports that comply with applicable regulations.

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Additional Responsibilities: You will write, investigate and ensure timely submission of complaints investigation, review and approve complaint investigation submitted by other team members, collaborate with other departments to ensure technical issues are being addressed and investigations are conducted thoroughly.

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Requirements and Qualifications: To be considered for this role, you must have a Bachelor's degree in a life science or related field and 2+ years of experience in pharmacy operation or cGMP environment. Strong written, verbal and presentation communication skills are essential, along with computer skills in database management and documentation preparation.

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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.

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Compensation and Benefits: The estimated salary for this position is $42.50 per hour. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits available include medical, dental & vision, critical illness, accident, and hospital insurance, 401(k) retirement plan, life insurance, short and long-term disability, health spending account, transportation benefits, and employee assistance program.

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Workplace Information: This is a fully onsite position located in Ledgewood, NJ. Please note that eligibility requirements apply to some benefits and may depend on your job classification and length of employment.

">$42.50-$52.00 per hour

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