Quality Associate I – Compliance
| Company | Baxter International |
|---|---|
| Location | Auburn, NY, USA |
| Salary | $64000 – $88000 |
| Type | Full-Time |
| Degrees | Bachelor’s, Associate’s |
| Experience Level | Entry Level/New Grad, Junior, Mid Level |
Requirements
- Associate degree in business/scientific discipline.
- Bachelor’s degree in the life sciences and experience with a medical device/pharma or other similarly regulated industry preferred.
- 1-3+ years of relevant experience.
- Strong interpersonal skills and great attention to detail are necessary.
- Must be able to handle multiple projects concurrently.
- Have strong knowledge of FDA Regulations, Application of Good laboratory Practices, and Application of Good Manufacturing Practices.
- Must be a strong team player with good problem solving and good verbal and written communication skills.
- Must have the ability to manage people, encourage teamwork and drive decisions.
Responsibilities
- Leads ongoing, daily departmental operations.
- May include the supervision of assigned personnel in achieving defined quality goals in an efficient, accurate and timely manner. Provide direct supervision of assigned individuals including mentoring, development, performance management and staffing decisions.
- Perform in depth internal assessments and evaluations by collecting and analyzing accurate, objective evidence regarding risks and their magnitude. Assessments and information gathering may be through in depth employee interviews, flow charting and other informational gathering techniques. Determine the logic, adequacy and effectiveness of processes, systems and related requirements. Develop plans to correct identified risks including areas of non-conformance, inform management and implement approved corrective action plans.
- Write, review, analyze and revise written Standard Operating Procedures (SOPs) and submit procedural changes as needed to meet all necessary requirements.
- Support external assessments or audits.
- Assist with audits of various reports (Protocols, Qualifications, Regulatory, Submissions, etc.).
- Serve as Subject Matter Expert (SME) and provide training to local employees as needed on relevant areas.
Preferred Qualifications
- Bachelor’s degree in the life sciences and experience with a medical device/pharma or other similarly regulated industry preferred.