Associate II, Quality (7pm-7am)

Baxter•Marion, NC

19h•Onsite

About The Position

Responsible for providing Quality support and oversight via direct staff supervision or process/area responsibilities. Identify and assess regulatory and quality risks in activities and processes according to regulatory agency rules and guidelines and Baxter quality practices. Within Quality, every role makes a difference. Products that Baxter makes are shipped worldwide for patients in need. Whether it's building a new process from scratch or facing a never-before-seen production hurdle, individuals within Quality are given the trust and opportunity to bring creativity to the table. Regardless of your specific role with a product, it is sure to touch a portion of our global operation. The mission of Baxter is to save and sustain lives. This mission is embedded into everything we do. This means if there is a decision to be made where quantity and quality are at odds, we will always choose quality. Our patients come first, always.

Requirements

High School Diploma, GED, or equivalent required.
Must be at least 18 years of age.
BS in engineering/science or equivalent work experience.
3-5 years exp. in Quality with a medical device/Pharma company or other similarly regulated industry.
Strong interpersonal skills and great attention to detail are necessary.
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.
Must be able to handle multiple projects concurrently, have computer experience and have knowledge of FDA Regulations, Application of Good Laboratory Practices, and Application of Good Manufacturing Practices.
Understand verbal and written safety and quality instructions and read and comprehend written work instructions including words and drawings.
Must have basic English written and oral communication skills adequate to communicate with other team members.
Other Duties as Assigned
Applicants must be authorized to work for any employer in the U.S. We are unable to sponsor or take over sponsorship of an employment visa at this time.

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; Interview/hire, evaluate, train and develop direct reports
Perform in-depth internal assessments and evaluations by collecting and analyzing accurate, objective evidence regard ing risks and their magnitude. Assessments and information gathering may be through in-depth employee interviews, flow charting and other informational gathering techniques.
Work closely with production supervisors, quality, engineering and other internal groups to accomplish the above and influence necessary actions.
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.
Serve as Subject Matter Expert (SME) by maintaining a high level of expertise in current regulatory requirements.
Provide training and coaching to local employees and others as needed on relevant area(s).
When required, assist other Quality areas in the successful performance of these activities.
Write, review, analyze and revise written Standard Operating Procedures (SOPs) and submit procedural changes as needed to meet Corporate, Divisional, Plant, Regulatory Requirements, etc.
Participate in external assessments and audits by evaluating and solving product/process problems by providing technical, analytical and supervisory skills
Support process with timely closure of observations/audit items.
Oversees audits of various reports (Protocols, Qualifications, Regulatory Submissions, etc.)
Participate in QA/QC multi-site projects in the role of contributor, coordinator or lead.
Other duties, tasks or projects as assigned.
Sustain a clean and safe work area using 6S principles
Learn, understand and apply rigorous quality standards, Standard Operating Procedures (SOPs) and Current Good Manufacturing Practices (cGMP)

Benefits

Medical, Dental and Vision coverage
160 hours of Paid Time Off and Paid Holidays
401K 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
commuting benefits
Employee Discount Program
Employee Assistance Program (EAP)
childcare benefits