The Senior Associate Quality Engineer is responsible for advanced quality oversight across daily operations, incident management, investigations, and client-facing quality activities. This position partners with Operations, Account Management, and internal/external customers to act as a quality liaison to drive risk-based decision making, identifies emerging quality risks, and contributes to continuous improvement initiatives to strengthen compliance and process efficiency.

Key Responsibilities

• Responsible for the oversight of the Corrective Action/Preventive Action (“CAPA”) program for their area of responsibility including but not limited to review all non-conformances to ensure they are documented, review all corrective/preventive actions for completeness, and execute effectiveness checks when required.

• Assist with Non-conformance Investigations assigned to Quality Assurance, as needed. Responsible for ensuring timely closure of CAPA records.

• Responsible for generating status reports from applicable QMS applications, analyzing data to identify potential trends and areas for improvement, and maintaining related company measurements.

• Responsible for repackaging and relabeling projects in support of client requests, as Project Leader. Including, but not limited to, communication with client and Program Manager regarding project details, pricing proposals for project, creation of the project protocol, inspection of the project as required by project protocol, and filing any necessary paperwork with client, Program Manager, and/or regulators.

• Manages all special client project requests, client complaint memos, and other relevant client memos.

• Serves as a back-up for the Associate Quality Engineer to perform the inspection and release process for incoming and returned product including but not limited to: downloading and review of temperature device data, communicating results to clients, obtaining proper client approval, electronic storage of inspection records, and product retains.

• Assists as needed with Client and Regulatory activities, Quality-related training, validation of storage areas/systems/equipment where required, and other duties and responsibilities as assigned by manager.

Shift:

11:00AM – 7:30pm THIS ROLE REQUIRES YOU TO BE ON SITE 5 DAYS A WEEK.

Minimum Job Qualifications:

Degree or equivalent and typically requires 2+ years of relevant experience.

Critical Skills:

• 3-5 years in a pharmaceutical quality/regulatory environment, preferred

• Quality Management System and/or Document control management experience, preferred.

• Knowledge of pharmaceutical regulations, including FDA requirements, preferred.

Preferred Skills:

• Ability to express ideas clearly both in written and oral communications.

• Ability to enter data accurately.

• Ability to handle multiple tasks well.

• Detail-oriented individual with thorough knowledge of word processing, database, and spreadsheet programs (preferably MS Office).

• Must possess the ability to work with internal departments to accomplish objectives and meet established deadlines.

• Must be personable, self-starter, possess a good attitude, and enjoy external and internal contact on the phone and in person with supervisors, co-workers, customers, and potential clients.