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This role is responsible for managing compliance areas, including Training, Document Control, Critical Systems, and Calibrations. It guarantees that operations maintain top standards.
Job Responsibility:
Direct and supervise compliance departments including Training, Document Control, Critical Systems, and Calibrations
Ensure compliance of manufacturing and quality control operations with corporate specifications, SOPs, GMP/QSR (21CFR 820), ISO 13485, EN ISO 13485
Perform administrative functions in AS400 Document Control and Exception Menu, PRN and CDR programs
Act as Site SME for BaxU and TCU
Determine suitability of changes based on process, product, and regulatory knowledge
Coordinate activities of a section/department in the Quality Compliance organization
Participate in or manage quality assessments of suppliers
Manage mentoring, training, and development of subordinates
Assist in the development of departmental budget
Initiate action to prevent nonconformities and identify product/process/system problems
Recommend and verify the implementation of solutions
Drive engagement through Leader Behaviors: Communication, Recognition, Feedback, Enabling Success
Take direct responsibility for internal and external audit compliance programs
Requirements:
Minimum bachelor’s degree, preferably in Science or Engineering
equivalent experience will be considered
5+ years of experience in a quality or operational role, including 1-2 years in a supervisory/managerial position
Strong interpersonal skills for interactions with suppliers, QA Manager, Production Manager, and Corporate/Divisional groups
Regular and occasional communication with internal and external audit groups, TÜV, and end users
May require overtime, including nights and weekends
Use of hands/fingers to manipulate office equipment
Standing/walking for extended periods
Safety-sensitive position under Arkansas Medical Marijuana Amendment
Reliable and regular attendance
What we offer:
Support for Parents
Continuing Education/ Professional Development
Employee Heath & Well-Being Benefits
Paid Time Off
2 Days a Year to Volunteer
medical and dental coverage that start on day one
insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance
Employee Stock Purchase Plan (ESPP)
401(k) Retirement Savings Plan (RSP)
Flexible Spending Accounts
educational assistance programs
paid holidays
paid time off ranging from 20 to 35 days based on length of service