QA Associate

Artech Information System LLC; Morris Plains (NJ); On-site; USD 55,000 - 75,000; Full time

Job summary

A leading IT staffing company is seeking a candidate with 0-3 years of GMP manufacturing or QA experience for a role in compliance and quality assurance. Responsibilities include ensuring adherence to regulatory requirements, coordinating batch records, and approving documents for raw materials. A BS/BA in Biological Sciences or equivalent experience is required. This position is critical to maintaining product quality and compliance with site standards.

Qualifications

• 0-3 years GMP manufacturing and/or QA related experience.
• BS/BA in Biological Sciences or equivalent relevant career experience.

Responsibilities

• Ensure compliance with cGMP legal and regulatory requirements.
• Coordinate and perform batch record issuance for internally manufactured products.
• Review and approve manufacturing and QC documents for raw material disposition.
• Perform administrative functions for filing and maintenance of records.
• Control costs within the department to meet budget.
• Complete training in electronic database and GMP, safety, and Compliance courses.
• Support tasks necessary for product quality and cGMP compliance.

Skills

GMP experience

QA experience

Education

BS/BA in Biological Sciences or equivalent relevant career experience

Job description

Artech is the 10th Largest IT Staffing Company in the US, according to Staffing Industry Analysts' 2012 annual report. Artech provides technical expertise to fill gaps in clients' immediate skill-sets availability, deliver emerging technology skill-sets, refresh existing skill base, allow for flexibility in project planning and execution phases, and provide budgeting/financial flexibility by offering contingent labor as a variable cost.

Responsibilities

1. Ensure that all aspects of the operational business comply with cGMP legal and regulatory requirements, the Client Pharma Corporate Quality Manual and Policies, and site procedures and business requirements.
2. Coordinate and perform batch record issuance for internally manufactured products.
3. Review and approve manufacturing and QC related documents for raw material disposition, manufactured media.
4. Perform administrative functions for filing and maintenance of records between QA operations and Document Control Center; support cGMP and associated OJT training to QA and other departments to improve "Right the First Time" (RTFT) and high quality performance.
5. Control costs within the department to meet budget.
6. Complete job-related training in electronic database system along with GMP, safety, and Ethics & Compliance course requirements.
7. Perform or support any other tasks necessary to maintain the product quality and site cGMP compliance, as needed.

Qualifications

• 0‑3 years GMP manufacturing and/or QA related experience.
• BS/BA in Biological Sciences or equivalent relevant career experience.