Associate I, Quality
About The Position
The Associate I, Quality provides Quality support and oversight through process- and area-related projects and process development. The role identifies and assesses regulatory and quality risks, evaluates processes and systems, develops corrective action plans, and supports internal and external assessments and audits. It also involves writing and revising Standard Operating Procedures, serving as a subject matter expert, training employees, and sustaining a clean and safe work area using 6S principles. The position requires learning and applying quality standards, SOPs, and current Good Manufacturing Practices.
Requirements
- At least 18 years of age.
- High school diploma or GED.
- Strong interpersonal skills and attention to detail.
- Strong team-player skills, problem-solving ability, and verbal and written communication skills.
- Ability to manage people, encourage teamwork, and drive decisions.
- Ability to manage multiple projects concurrently.
- Computer experience.
- Knowledge of FDA regulations and application of Good Laboratory Practices and Good Manufacturing Practices, as appropriate.
- Ability to understand verbal and written safety and quality instructions and read and comprehend written work instructions, including words and drawings.
- Basic English written and oral communication skills adequate to communicate with other team members.
- Must be authorized to work for any employer in the U.S.; visa sponsorship is unavailable.
Nice To Haves
- Bachelor's degree strongly preferred.
- Degree in engineering or science preferred.
Responsibilities
- Identify and assess regulatory and quality risks in activities and processes according to regulatory agency rules, guidelines, and Baxter quality practices.
- Lead ongoing, daily departmental operations.
- May supervise assigned personnel in achieving quality goals, including interviewing, hiring, evaluating, training, and developing direct reports.
- Conduct in-depth internal assessments and evaluations by collecting and analyzing accurate, objective evidence about risks and their magnitude.
- Gather information through employee interviews, flow charting, and other techniques.
- Determine the logic, adequacy, and effectiveness of processes, systems, and related requirements.
- Develop plans to correct identified risks and non-conformance, inform management, and implement approved corrective action plans.
- Write, review, analyze, and revise Standard Operating Procedures (SOPs), and submit procedural changes as needed to meet corporate, divisional, plant, and regulatory requirements.
- Support external assessments or audits and assist with audits of reports such as protocols, qualifications, and regulatory submissions.
- Serve as a subject matter expert and provide training to local employees as needed.
- Sustain a clean and safe work area using 6S principles.
- Learn, understand, and apply quality standards, SOPs, and current Good Manufacturing Practices (cGMP).
- Perform other duties, tasks, or projects as assigned.
Benefits
- Medical, dental, and vision coverage
- Paid time off and paid holidays
- 401(k) match
- Employee Stock Purchase Program
- Paid parental leave
- Tuition reimbursement
- Basic life, accident, short-term and long-term disability, and business travel accident insurance
- Flexible Spending Accounts
- Family and medical leaves of absence
- Commuting benefits
- Employee Discount Program
- Employee Assistance Program
- Childcare benefits
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Education Level
High school or GED
