QA Associate
Beacon Hill Staffing Group

Job Info

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Beacon Hill Pharma is currently hiring a QA Associate for an opportunity in the Somerset, NJ area!

ACCOUNTABILITIES:

• Maintains the finished product reserve appropriate sampling and FDA retention sample storage areas.
• Provide administrative assistance to the Serialization team and CMOs to ensure DSCSA compliance.
• Review labeling, advertising, and promotional labeling to ensure compliance to policies and guidelines.
• Maintain knowledge of current/changing regulations/guidelines/standards and co-ordinate with regulatory teams at manufacturing facilities
• Assist in the review and revision of SOP's, protocols, and special studies required for compliance with batch record.
• Assures compliance to SOP's and cGMP's.
• Support and coordinate with the QA team on training requirements, product releases and review of batch records, deviations, and investigations.
• Review of Material Management forms to assure accuracy of information and components for production.
• Draft and maintain Quality documents/filings as per requirements.
• Responsible to monitor the Production floor to ensure all operations are being performed according to written procedures.
• Responsible for timely completion of regulatory projects and submissions of documentation to regulatory agencies.
• Review documents/reports for regulatory submissions as per USFDA guidelines and other international cGMP norms.
• Review additional information/responses as requested by regulatory agencies.
• Ensure compliance to relevant regulations as standards by evaluating and addressing product/process changes and deviations from regulatory commitments.

REQUIRED EXPERIENCE TO APPLY FOR POSITION:

• Bachelors preferred but not required
• Looking for 1-2 years' experience in pharma or FDA regulated environment

Beacon Hill is an Equal Opportunity Employer that values the strength diversity brings to the workplace. Individuals with Disabilities and Protected Veterans are encouraged to apply.

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Company Profile:

Founded by industry leaders to set a new standard in search, career placement and flexible staffing, we deliver coordinated staffing solutions with unparalleled service, a commitment to project completion and success and a passion for innovation, creativity and continuous improvement.

Our niche brands offer a complete suite of staffing services to emerging growth companies and the Fortune 500 across market sectors, career specialties/disciplines and industries. Over time, office locations, specialty practice areas and service offerings will be added to address ever changing constituent needs.

Learn more about Beacon Hill Staffing Group and our specialty divisions, Beacon Hill Associates, Beacon Hill Financial, Beacon Hill HR, Beacon Hill Legal, Beacon Hill Life Sciences and Beacon Hill Technologies by visiting www.beaconhillstaffing.com.

We look forward to working with you!

Beacon Hill. Employing the Future™

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