Compliance Associate

TOWER LABORATORIES•Essex, CT

About The Position

Tower Laboratories is a family-owned U.S. manufacturer of effervescent products, including over-the-counter medications, prescription pharmaceuticals, nutritional supplements, soft drink tablets, and other consumer products made on a contract basis. The Compliance Associate is a salary-exempt professional role handling regulatory administrative activities, largely involving FDA requirements related to cGMP, and significant records management. The position reports to the Compliance Manager. The role prepares, routes, and manages quality documentation; reviews and approves site documentation for regulatory and internal compliance; supports training development and records; and manages the complaint process from intake through investigation, reporting when required, responses, and trend tracking. The Compliance Associate also supports customer and agency audits and inspections and manages product registration activities, including liaison with customers.

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, and the ability to respond quickly to business needs with a “will do whatever it takes” attitude.

Nice To Haves

  • College degree preferred.

Responsibilities

  • Prepare, route, and manage quality documentation, including high-level SOPs, Change Control, and CAPA.
  • File and store quality documentation to ensure it can be readily retrieved.
  • 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, including completing training records.
  • Manage the complaint process, including intake, logging, risk assessment, investigations, filing MDRs when required, responding to consumers, and tracking and trending.
  • Support customer and agency audits and inspections by providing and reviewing files, providing trend information, and responding to questions when necessary.
  • Manage product registration activities, including liaising with customers about information required for registration or supplier approval.

Benefits

  • 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
  • 9 paid holidays
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