Manufacturing Lead (1st Shift)

Leiters Health • Englewood, CO

243d

About The Position

This description is intended to be illustrative of the major duties performed by the employee recruited to this position. Performs other duties as assigned. This position reports directly to the Production or Formulation Supervisor. The role is responsible for leading technicians during active manufacturing operations within the Sterile Compounding Area. The Manufacturing Lead is responsible for coordinating activities within the Sterile Compounding Area in support of the production schedule.

Requirements

• 1-year previous leadership experience or comparable experience preferred.
• Minimum 1 years' experience in aseptic processing preferred.
• Knowledge of cGMP guidelines/standards.
• Bachelor's degree or equivalent, relevant experience.
• Demonstrated written and oral communications skills including strong presentation skills.
• Excellent organizational skills.
• Strong results orientation.
• Microsoft Office skills, including use of spreadsheets and word processing programs.
• Negotiation and ability to effectively bring others together and reconcile differences.
• Must pass English Competency Test.
• Proficient written, verbal and oral English communication skills.

Responsibilities

• Assist Production/Formulation supervisor in overseeing employees who are responsible for formulation or aseptic filling of sterile ophthalmic and injectable solutions.
• Collaborate with Production Supervisors to ensure completion of Formulation/Filling of products to meet scheduled release dates.
• Provide strong people leadership with a focus on creating/maintaining a positive work environment through effective communication, performance management, accountability, etc.
• Ensure training on SOPs and processes remains current.
• Ensure compliance with company policies, FDA regulations, safety standards, and GMPs.
• Collect data to support production efficiencies including processing time, downtime, and waste.
• Perform investigations, CAPA actions, and support deviation resolution for non-conformances in the manufacturing department.
• Work with QA to quickly resolve any variance or document errors so that product may be released on time.
• Lead trouble shooting and problem solving activities in support of production operations.
• Support and participate in process improvement projects and initiatives for the manufacturing department.
• Support Supervisor in the management of daily staffing to meet the daily production schedule.
• Able to lift up to 50 lbs. and stand for extended periods when required.
• Maintain gown qualification for ISO 7 area and aseptic process qualification for ISO 5 area.

Benefits

• 100% employer paid medical plan.
• Dental & Vision insurance options including FSA & HSA.
• Employer Paid Life Insurance & Employee Assistance Program.
• Short Term & Long-Term Disability Insurance.
• Up to 4% 401K Matching (100% vested on day one!).
• Generous Paid Time Off Options - vacation, sick, paid leave and holidays!
• $5,250 Annual Tuition Reimbursement after 6 months.
• $1,000 Referral Bonus Program with no limit.
• Eligible for annual bonus program.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: Bachelor's degree