Compliance Associate

POSITION SUMMARY:

Our Compliance Associates are salary-exempt professional positions responsible for handling a variety of regulatory administrative activities (largely FDA requirements as pertains to cGMP) and significant Records Management. Reports to the Compliance Manager.

ESSENTIAL FUNCTIONS:

1. Prepares, routes and manages quality documentation including high level SOPs, Change Control, CAPA, etc. Responsible for filing and storage of quality documentation to ensure ease of retrieval.
2. Reviews and approves site documentation to ensure compliance with Good Manufacturing Practices (cGMP) regulations, internal standards and local regulations.
3. Supports all departments in the development of training packages for new hires, SOP changes, etc. including completion of training records.
4. Manages the complaint process. This includes but is not limited to intake, logging, performing risk assessment and the required investigations, filing MDRs when required, responding to consumers, and tracking and trending.
5. Supports customer and agency audits and inspections. This is done by providing all necessary files, review of the files, providing trend information and when necessary responding to questions.
6. Responsible for all product registration activities including liaison with customers regarding any information they may require for registration or supplier approval.

POSITION REQUIREMENTS:

• Knowledge of cGMP strongly preferred.
• Proficiency in Microsoft Office; MS Word and Excel
• Strong sense of ownership and accountability.
• Demonstrated ability to prioritize and manage multiple projects simultaneously.
• Strong communication skills; both written and oral.
• Exceptional attention to detail.
• Commitment to quality and continuous improvement.
• Must be flexible with outstanding work ethic and possess the ability to respond quickly to business needs and have “will do whatever it takes” attitude.
• College degree preferred

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.