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Altium Packaging Quality Compliance Specialist in United States

Location Address:

600 Vista Drive, Sparta, Tennessee 38583

Work Shift:

Salary Exempt (United States of America)

This position is responsible for ensuring compliance with regulations related to packaging and labeling of pharmaceutical products within Altium Healthcare. This position requires project management capabilities responsible for leading the end-to-end planning, coordination, and execution of assigned deliverables, including delivery as an individual contributor.

• Responsible for document creation, review, and approvals.• Implement systems to maintain compliance with current good manufacturing practices (cGMPs), environmental health and safety (EHS) guidelines, and any other regulations that apply.• Ensure 100% compliance with established department procedures and regulations in producing high quality pharmaceutical packaging. • Communicate nonconformances. Request root cause analysis, corrective, and preventative actions. Audit results.• Ensure departments responsible for products meet quality standards and performance goals.• Support the Plant’s compliance activities through accurate regulatory recordkeeping and reporting.• Ensure all aspects of cGMP product release meet analytical, production, packaging, labeling specifications in accordance with established quality systems.• Manage Quality Management System (QMS) to ensure alignment with corporate and regulatory standards such as ISO 9001 and cGMP.• Review and approve quality documentation such as procedures, deviation, CAPA plans, OOS investigations, risk assessments and change controls to ensure compliance.• Timely completion of Safety related items to include Trainings and Safety Observations.• Other duties as assigned by management.

Qualifications:Required:• Bachelor’s degree or related business area or minimum 3 years of experience in Quality with demonstrated knowledge of GMP, GLP and FDA trends.• Excellent organizational and project management skills to coordinate multiple projects.• Strong interpersonal communication skills required – verbal, written and presentation. • Ability to work independently and as part of a team.• Above average influence and stakeholder management skills.• Ability to analyze problems and recommend actions.• Proficiency in Word and Excel are required. • Travel as needed (10% to 20%).

Altium Packaging, Our Culture Differentiates Us! We incorporate our Guiding Principles into all aspects and at all levels of the organization and use them as a framework for decision-making. We believe our Guiding Principles foster a culture of excellence that benefits both employees and customers.

Our Guiding Principles

  • Act with Integrity & in Compliance

  • Drive Value Creation

  • Be Disciplined Entrepreneurs

  • Focus on the Customer

  • Act with Humility

  • Treat others with Dignity and Respect

  • Seeking Fulfillment in your Work

We Believe in Rewarding our Most Important Resource – Our People! We show our commitment to Total Rewards by providing a competitive, comprehensive benefits package. In addition to medical, dental and vision plans, company holidays and vacation days, tuition reimbursement, learning and training opportunities, bonus potential, and a 401(k) plan with company contributions, Altium Packaging locations offer rewards and recognition programs and opportunities to make a difference in the community.

EEO Statement

We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity and/or expression, status as a veteran, and basis of disability or any other federal, state or local protected class.

Take your career to the next level at Altium Packaging!

We are the National Leader in a Stable, Growing Industry!

Altium Packaging is a leading developer and manufacturer of rigid plastic packaging solutions in North America. We serve a diverse customer base in the dairy, household chemicals, food/nutraceuticals, industrial/specialty chemicals, water, pharmaceuticals, and beverage/juice segments.

With a network of more than 70 rigid plastic packaging manufacturing facilities, two recycled resins facilities, and 4,000 employees, Altium Packaging has an integrated network that consistently delivers reliable and cost-effective packaging and recycled resin solutions to meet the needs of a wide range of customers. From its state-of-the art Studio PKG™, to the recycling technologies of Envision Plastics, to its experienced manufacturing teams across its network, Altium Packaging delivers high performance, cost-effective solutions.

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