2nd Shift Senior Quality Assurance Associate

Summary:

The QA Associate supports the Quality Assurance Manager in upholding the Quality Management System. Maintain product quality, cGMP and regulatory compliance requirements. Oversee compliance and support operations in manufacturing and warehouse on the second shift. Ensure adherence to company procedures. Support continuous improvement of the quality system.

Hours:

3:30 AM to 12:00 PM Monday through Friday

Extended hours during the week and Saturdays and Sundays may be required as necessary to support the business needs.

This is a 100% on-site job

Responsibilities:

Batch record issuance and review

Prepare and review documents for operations

Review Certificate of Analysis

Keep track of material status

Author, revise and track status of Standard Operating Procedures (SOP’s)

Write investigations and change controls

Implement CAPA

Conduct training

Support internal audits

Assist in customer and regulatory audits

Compile information for Annual Product Reviews (APR’s)

Schedule calibration/certification services

Address customer requests and questionnaires

Track vendor qualifications

Data entry and collection

Maintain data integrity

Manage controlled documents

Review shipment inspection forms

Other duties assigned by Management

Education Requirements;

Bachelor’s degree (science major preferred) with a minimum of 1 year experience in regulated, cGMP environment (pharmaceutical/manufacturing industry preferred)

Other Requirements:

Excellent cGMP documentation skills

Very high attention to detail

Excellent organization skills

Effective written and verbal communication skills

Excellent interpersonal skills

Must proficiently speak, read and write in English

Ability to multi-task in a fast-paced environment

Trustworthy; must maintain confidentiality

Must be able to work in a collaborative environment with minimal supervision