Associate I, Quality

Baxter•Marion, NC

About The Position

The Associate I, Quality provides Quality support and oversight through process- and area-related projects and process development. The role supports departmental operations and helps identify, assess, and address regulatory and quality risks in accordance with regulatory agency rules, guidelines, and Baxter quality practices. It also contributes to internal assessments, procedure development, external audits, employee training, and the maintenance of a clean and safe work area. The position requires applying rigorous quality standards, Standard Operating Procedures (SOPs), and Current Good Manufacturing Practices (cGMP). Overtime is worked as required.

Requirements

Must be at least 18 years of age.
High school diploma or GED required.
Strong interpersonal skills and attention to detail.
Strong team-player skills and good problem-solving abilities.
Good verbal and written communication skills, including basic English communication adequate for communicating with team members.
Ability to manage people, encourage teamwork, and drive decisions.
Ability to handle 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.

Nice To Haves

Bachelor's degree strongly preferred; a degree in engineering or science is 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 and, where applicable, supervise assigned personnel in achieving quality goals efficiently, accurately, and on time.
Interview, hire, evaluate, train, and develop direct reports.
Conduct internal assessments and evaluations by collecting and analyzing objective evidence about risks and their magnitude, using methods such as employee interviews and flow charting.
Evaluate the logic, adequacy, and effectiveness of processes, systems, and related requirements.
Develop plans to correct identified risks and areas of 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.
Assist with audits of reports, including protocols, qualifications, and regulatory submissions.
Serve as a Subject Matter Expert (SME) and provide training to local employees in relevant areas as needed.
Sustain a clean and safe work area using 6S principles.
Learn, understand, and apply quality standards, SOPs, and cGMP.
Perform other duties, tasks, or projects as assigned.

Benefits

Medical, dental, and vision coverage beginning on day one.
160 hours of paid time off and paid holidays.
401(k) match.
Employee Stock Purchase Program.
Paid parental leave.
Tuition reimbursement.
Basic life, accident, short-term disability, long-term disability, and business travel accident insurance.
Flexible Spending Accounts.
Educational assistance programs.
Paid time off ranging from 20 to 35 days based on length of service.
Family and medical leaves of absence.
Commuting benefits.
Employee Discount Program.
Employee Assistance Program (EAP).
Childcare benefits.