QUALITY ASSOCIATE -PHARMACEUTICAL MFG.

TOWER LABORATORIES LTD.•Clinton, CT

16h•Onsite

About The Position

Tower Laboratories is a leading effervescent product manufacturer in the U.S. They develop and manufacture over-the-counter medications, prescription pharmaceuticals, nutritional supplements, soft drink tablets, and other consumer products on a contract basis. The company is family-owned and has been in business for over 40 years. This is a 2nd shift, salary exempt position with minimum hours of Monday to Friday, 3:50 PM to 12:20 AM. The role is responsible for enforcing Tower Laboratories, Ltd. quality system to ensure the production of a consistently high-quality product. The associate will work closely with production staff to ensure that effervescent tablets and powders are manufactured in accordance with applicable procedures, specifications, and in a cGMP (current Good Manufacturing Practices) compliant manner. The role partners with manufacturing throughout the production lifecycle to assure that procedures are followed and activities are appropriately documented.

Requirements

Minimum of 2 years’ experience in either pharmaceutical, food/beverage, nutritional supplement or another highly regulated environment.
Demonstrated strong attention to detail.
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.

Nice To Haves

Knowledge of cGMP regulations highly preferred.

Responsibilities

Perform product manufacturing audits throughout the process through observation and by conducting in-process testing to ensure product meets specifications.
Conduct packaging audits 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.