Product Line Lead

Essential Job Functions

• Supervise, manufacturing team responsible for production of assigned products.
• Assist in the manufacturing of products in accordance with Batch Records and Standard Operating Procedures (SOPs).
• Ensure quality records, including logbooks, procedures, training records, etc. are completed.
• Implement process improvements with emphasis on quality, safety and cost reduction.
• Monitor and control production costs.
• Oversee the transfer of manufacturing processes from R&D to commercial launch.
• Develop and implement validation protocols and master plans.
• Enforce cGMP's, safety regulations and environmental requirements.
• Ensure assigned personnel are effectively trained in their job requirements.
• Investigate quality issues and prepare investigation reports (CARs).
• Write and revise Batch Records and Standard Operating Procedures (SOPs).
• Prepare and track required GMP documents (ECOs, Process Deviations, Product Dispositions).
• Maintain adequate inventory to prevent backorders and excessive production costs.
• Prepare Annual Product reports and Quarterly trending.
• Initiate action to prevent the occurrence of nonconformities.
• Organize equipment files and meet preventive maintenance and calibration deadlines.
• Maintain supplies and requisition as needed.
• Perform performance management for all assigned personnel.

Competencies

• Meaningful Innovation
• Ownership/Accountability
• Pace/Efficiency
• Teamwork/Collaboration
• Integrity/Ethical Practice
• Resilience/Grit
• Physical Demands

Education, Experience and Certification

• This position requires a minimum of a minimum of a GED/high school diploma with four (4) years of medical device or pharmaceutical manufacturing experience or a Bachelor’s degree in engineering or sciences with 2 years medical device or pharmaceutical manufacturing experience.
• Experience with Microsoft software applications (Word, Excel, Power Point).
• Ability to perform detailed document review.
• Ability to work in a team environment.
• Strong organizational skills ability to simultaneously track multiple projects.
• Excellent communication skills (oral and written).

Total Rewards & Benefits

• Company performance bonus eligibility
• 401(k) plan with company contribution
• Paid time off and paid holidays
• Medical, prescription, dental, and vision insurance
• Companypaid life and AD&D insurance
• Wellness Program and Employee Assistance Program (EAP)
• Tuition Reimbursement

Salary Range

$28-$32 per hour