QA Auditor

QA Associate

Hamilton Connections has a QA associate position on 2nd shift at a Pharmaceutical company in Clinton, CT available. Pay range starting at 55k. Temp to hire positions available. Fast-paced blending keeps products moving!

Position Summary for QA:

This is a 2nd shift, minimum hours will be Monday to Friday, 3:50PM to 12:20AM. Responsible for the enforcement of Tower Laboratories, Ltd. quality system, which ensures production of a consistently high quality product. Work closely with production staff to ensure that our effervescent tablets and powders are manufactured in accordance with applicable procedures, specifications and in a cGMP (current Good Manufacturing Practices) compliant manner. Partners with manufacturing throughout production life cycle to assure that procedures are followed and activities are appropriately documented.

Essential Functions:

• Perform product manufacturing audits throughout process through observation and by conducting in-process testing to ensure product meets specifications.
• Conduct packaging audit ensuring final product meets packaging specifications and is within the allowed accepted quality limits (AQL); inspect all incoming packaging components, ensuring specifications are met by performing appropriate tests following determined component specifications.
• Conduct investigations as directed and collect information to assess root causes when product or processes are not meeting specifications.
• Assist in the conduct of internal audits of cGMP to ensure compliance to cGMP and internal procedures and policies.
• Audit finished/completed batch production documents for procedural or mathematical errors prior to final review and release of product by the QA Manager.
• Communicate identified manufacturing deficiencies to key personnel (Machine Operator, Quality Supervisor/Manager, Production Manager, etc.).
• Verify that all instrumentation used are calibrated and perform equipment calibrations as identified.
• Work as a team member; be cooperative with all departments and staff to meet company objectives.
• Perform all work in accordance with established Safety, cGMP and company procedures.
• Other responsibilities as assigned.

Essential Skills and Experience:

• Minimum of 2 years' experience in either pharmaceutical, food/beverage, nutritional supplement or another highly regulated environment.
• Demonstrated strong attention to detail.
• Knowledge of cGMP regulations highly preferred.
• Working knowledge of MS Word and MS Excel.
• Must be able to read and follow directions, complete paperwork and communicate effectively in English.
• Excellent organizational skills.
• Good interpersonal skills; ability to communicate effectively with all levels of plant personnel.
• Strong team player, demonstrated team attitude and behaviors.

Physical Demands:

• QA will Lift, push, pull up to 25lbs. on occasional basis
• Climb stairs, walking throughout manufacturing/warehouse areas
• Must be able to wear safety shoes & safety glasses when in manufacturing/warehouse areas
• Must be able to wear sanitary attire such as gloves, hairnet, face mask and lab coat.