Quality Compliance Associate II
Job Summary:
The Quality Compliance Associate II is responsible for coordinating general cGMP compliance activities. The Associate II will primarily be responsible for day-to-day management of the cGMP change process including initial assessment of change proposals, triage of impact assessment and change approvals, deployment of implementation tasks, and monitoring change completion. The Associate II will also support internal cGMP audit activities and provide support for external customer audits and regulatory inspections.
Responsibilities:
- Reviews all change proposals for accuracy and completeness. Work with the change originator if clarification or additional information is needed.
- Assigns impact assessments to SMEs as appropriate to evaluate the proposed change and identify any deliverables/actions needed for the change.
- Summarizes assessments and assigns tasks as needed to implement the change.
- Monitors the completion of changes and follow up with other departments, as needed.
- Maintains audit files for all internal and external (customer and regulatory) audits. This requires strong organization and time management skills.
- Performs internal audit tasks as assigned. This will require strong communication skills while interacting with other departments.
- Provides support during customer audits and regulatory inspections. This includes preparing the room, gathering requested materials, etc.
- Assists with other QA general compliance topics, as needed. This may include, but is not limited to, basic document control activities and training scheduling / support.
Education/Qualifications:
- High School Diploma/GED required; Bachelors degree preferred.
- A minimum of 6 years of experience in the pharmaceutical or related industry with demonstrated use and knowledge of cGMPs is required.
- Previous experience with regulatory compliance, project management, and/or quality assurance is preferred.
- Strong observational skills and attention to detail are required.
- Strong follow-up skills and ability to provide timely closure of assigned tasks.
- Strong computer skills are required with proficiency in the following applications desired: MS Word, MS Excel, Adobe products, and MasterControl. Familiarity with SAP is a plus.
- Strong communication skills (both oral and written) is required.
- Strong interpersonal skills with ability to work in a team setting and cooperate with various departments, personalities, and titles.
- Expected to sit at a desk / computer most of the workday.
- Must be able to walk across the plant to support audit tours.
- Travel is not expected.
On-site position. Mon-Fri (8a-5p)
