Compliance Associate

Tower Laboratories•Essex, CT

2d•$60,000 - $70,000

About The Position

Tower Laboratories is a family-owned effervescent product manufacturer headquartered in Centerbrook, Connecticut. The Compliance Associate is a salary-exempt professional responsible for regulatory administrative activities, largely relating to FDA requirements and current Good Manufacturing Practices (cGMP), as well as significant records management. The position reports to the Compliance Manager. The role prepares, routes, manages, files, and stores quality documentation; reviews site documentation for regulatory and internal compliance; supports departmental training; manages the product complaint process; supports customer and agency audits and inspections; and handles product registration activities, including communication with customers about registration and supplier-approval information. Tower Laboratories describes its work environment as friendly and offers a complete benefits package to eligible full-time employees after applicable waiting periods. The company is an equal opportunity employer and makes efforts to provide reasonable workplace accommodations.

Requirements

Knowledge of cGMP is strongly preferred.
Proficiency in Microsoft Office, including Word and Excel.
Strong sense of ownership and accountability.
Ability to prioritize and manage multiple projects simultaneously.
Strong written and oral communication skills.
Exceptional attention to detail.
Commitment to quality and continuous improvement.
Flexibility, an outstanding work ethic, responsiveness to business needs, and a willingness to do whatever it takes.

Nice To Haves

College degree preferred.
Knowledge of cGMP strongly preferred.

Responsibilities

Prepare, route, and manage quality documentation, including high-level SOPs, Change Control, and CAPA; file and store quality documents for easy retrieval.
Review and approve site documentation for compliance with cGMP regulations, internal standards, and local regulations.
Support departments in developing training packages for new hires and SOP changes, and complete training records.
Manage the complaint process, including intake, logging, risk assessment, required investigations, filing MDRs when required, consumer responses, and tracking and trending.
Support customer and agency audits and inspections by providing and reviewing files, supplying trend information, and responding to questions when necessary.
Handle product registration activities, including liaising with customers about information needed for registration or supplier approval.