Packaging Operations Manager

6 days ago

Greenville, North Carolina, United States Mayne Pharma Group Ltd Full time
Job Summary

This role is responsible for assisting shift supervision in providing direction and support to operators to ensure timeliness and accuracy in the completion of packaging batches. The successful candidate will conduct training and participate in the more skilled work performed by Packaging Line Operators.

Key Responsibilities
  • Documentation Maintenance: Ensure that all work is accurate, precise, properly documented, completed and compliant with company Standard Operating Procedures as well as FDA and cGMP guidelines.
  • Equipment Maintenance and Troubleshooting: Identify and resolve process and/or equipment failures; initiate appropriate action to prevent reoccurrence.
  • Proactive Operational Support: Provide proactive guidance and direction to line operators for the successful packaging of commercial and large-scale clinical batches as well as assure quality standards are understood and maintained from inception to completion.
Specific Responsibilities
  • With minimal supervision, provide direction to operators in the packaging and labeling of full commercial scale batches, scale-up, development and CTM batches.
  • With minimal supervision, assemble, disassemble, clean and store packaging equipment.
  • Document packaging and labeling steps in batch records accurately and completely as required and confirm documentation is completed with minimal errors.
  • Perform start-up and in-process testing accurately and ensure proper documentation Complete QAD transactions for components and finished goods.
  • Update work order when needed to complete batch.
  • Recognize potential problems and provide input on corrective action(s).
  • Lead SMEs in training staff.
Key Competencies/Requirements
  • Accountability: Assume responsibility for successfully accomplishing work objectives and delivering business results; setting high standards of performance for self and others.
  • Agility: Respond positively to change, embracing and using new practices or values to accomplish goals and solve problems.
  • Creativity: Explore and advances opportunities to develop novel solutions and approaches to the improvement of processes and services.
  • Empowerment: Find opportunities to improve and extend their contribution to the organization and their teammates.
  • Integrity: Demonstrate the highest commitment to integrity and showing respect for and value all individuals for their diverse backgrounds, experiences, styles, approaches and ideas.
  • Passion: Evidence passion for the organization, our people, and the difference we make daily in improving the lives and health of people.
  • Attention to Detail: Ensure information is complete and accurate; follow up with others to ensure that agreements and commitments have been fulfilled.
  • Communication: Deliver clear, effective communication and take responsibility for understanding others.
  • Time Management: Establish a systematic course of action for self or others to ensure accomplishment of a specific objective; set priorities, goals, and timetables to achieve maximum productivity.
Qualifications
  • Bachelors degree with 2 years of relevant experience in the pharmaceutical industry.
  • Associate degree with 5 years of relevant experience in the pharmaceutical industry.
  • At least 6 years of experience in a pharmaceutical production area, including leadership experience resulting in sound functional understanding of pharmaceutical manufacturing processes.
  • Must be able to use QAD (inventory Management System) to assist in the timely start and completion of batches and documentation.
Physical Requirements
  • Position requires the ability to lift in excess of 50lbs unassisted.
  • Majority of work day is performed while standing, walking, lifting, pulling, pushing.
  • Requires the use of hands for simple grasping and fine manipulations.
  • Requires bending, squatting, reaching, pushing, climbing.
  • Requires the ability to stand for extended periods of time.
  • Some exposure to hazardous chemical and other active chemical ingredients.
  • Must be able to use a variety of tools, equipment, and machinery.

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