2nd SHIFT QUALITY AUDITOR -PHARMACEUTICAL MFG.

QA ASSOCIATE- 2nd Shift Tower Laboratories is a leading effervescent product manufacturer in the U.S. We develop and manufacture over-the-counter medications, prescription pharmaceuticals, nutritional supplements, soft drink tablets and other consumer products on a contract basis. We are continually expanding our effervescent product base and currently have several new and interesting products in the research and development phase right now. Learn more about us at www.towerlabs.com. Our company is family owned and headquartered in the scenic town of Centerbrook in Southeastern Connecticut. We offer a friendly working environment and complete benefit package, including a 401(k) with generous company match. Tower Labs is a Socially Responsible Employer and a great place to work! POSITION SUMMARY: 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. 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; strong attention to detail. Good interpersonal skills; ability to communicate effectively with all levels of plant personnel. Strong team player, demonstrated team attitude and behaviors. EDUCATION: High school diploma or equivalent. BENEFITS AND SALARY INFORMATION: Full-time employees are eligible for the following benefits after meeting any applicable waiting periods: Medical insurance HSA and FSA options Dental insurance Vision insurance Accident, critical illness, and hospital indemnity insurance Voluntary life insurance Company-paid life insurance Long-term disability coverage 401(k) with an employer contribution of up to 3% Paid time off, sick time, and 9 paid holidays We believe that diversity makes us stronger, personally and professionally! We are an equal opportunity employer and all qualified candidates will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, genetic information, veteran status, or any other characteristic protected by law. We make every effort to make reasonable accommodations in the workplace.