General Description:
This position reports to the Quality Systems Manager. The Quality Engineer performs inspections and investigates deviations from current quality practices. Assists in developing quality control policies and evaluates production limitations. The candidate should have a good understanding of cGMP requirements. The position requires an individual who works independently and in a team environment, experienced in cGMP requirements, quality control, attention to detail, and excellent communication with other functional areas and sites.
Essential Functions:
This description is intended to be illustrative of the major duties performed by the employee assigned to this position.
- Lead investigations for quality events, deviations and complaints
- Review and assist with implementation of changes through the change control process.
- Lead and assist with internal audits through the internal audit program.
- Assist with regulatory inspections and serve as Subject Matter Expert (SME) related to quality systems including deviations, CAPAs, change controls, etc.
- Implementing methods to inspect, test and evaluate the reliability of the manufacturing processes, products, and product equipment
- Prepare and deliver on time investigation reports by collecting, analyzing, and summarizing data
- Serve as Subject Matter Expert (SME) and ensure compliance with integrity of BMRAM system staying current with quality reviews and improving timeliness of equipment calibration.
- Provide quality guidance, expertise, and services in collaboration with all departments to ensure decisions for processes, data and product are quality driven, compliant to batch records, operating procedures, and regulatory requirements.
- Engage in cross-functional team discussions for issue resolution, process improvements and/or triage and initiate event records.
- Partner with peers to ensure alignment on issue resolution, decisions for processes, and compliance to batch records.
- Create, revise, and author documents and deviation records.
- Perform trending reports.
- Assist with 503B regulatory activities such as state regulatory reporting, DEA record keeping and diversion investigations.
- Other duties as assigned.
SUPERVISORY RESPONSIBILITIES:
EXPERIENCE AND NECESSARY COMPETENCIES:
- Bachelor’s degree in relevant field or equivalent experience required.
- 3+ years of quality experience required, preferably in a regulated industry.
- Knowledge and experience of compounding techniques and controlled environments is preferred.
- Knowledge of appropriate materials and conditions is preferred
- Ability to identify potential adverse issues
- Excellent organization and documentation skills
- Demonstrated ability to solve problems of limited scope and complexity, seeks management guidance as required.
- Collaborative spirit, able to work with a team to ensure that the systems involved in a 503B outsourcing facility are in a state of control
- Understanding of 503B regulatory requirements, cGMP standards, and USP guidelines is a plus!
- Proficient written, verbal and oral English communication skills are required.
- Proficiency with Microsoft 365 tools including Outlook, Microsoft, and Excel.
Physical Requirements:
- Ability to stand or sit for extended periods of time.
- Ability to lift, push and pull up to 50 pounds periodically.
