Lead Production Technician - ILP 1st Shift
About the role
Once you complete our training, you will oversee planning, scheduling, staffing, and daily execution for the inspection, labeling, and packaging of compounded sterile products (CSPs) and non-sterile solutions. This position is responsible for daily coordination and working schedules of people and equipment in production operations, ensuring proper line controls, appropriate documentation, and timely completion of batch records. You will coordinate activities to ensure line support and staffing while adhering to safety requirements, current Good Manufacturing Practices (21CFR210 and 211), company policies, and procedures.
At Quva, you will be an essential part of a mission-driven organization dedicated to expanding critical access to quality, affordable medication and data insights while promoting a culture of innovation, collaboration, and continuous improvement. Your attention to detail and adherence to precise procedures will guarantee that our medications meet the highest standards of safety, efficacy, and quality.
Responsibilities
- Oversees inspection, labeling, and packaging operations, including scheduling, processing, and completion of finishing activities in support of CSPs, bulk bags, and non-sterile solutions.
- Serves as a knowledgeable resource for team members needing assistance with products or procedures, and as a subject matter expert (SME) for cross-functional project teams.
- Works with label printing teams to ensure appropriate inventory of labels is maintained to support production, escalating as needed to meet targets.
- Supports development of weekly ILP plans and schedules.
- Performs and participates in investigations related to non-conforming product or execution of procedures.
- Communicates effectively with Operations, Quality, Receiving/Shipping, and other functional support staff.
- Ensures timely communication and coordination of activities to meet established timelines for delivery and internal processing.
- Identifies process improvements and promotes an environment of continuous improvement.
- Resolves and escalates non-routine incidents immediately.
- Ensures proper cleaning of processing rooms in accordance with procedures.
- Assists site management as directed.
- Conducts initial and ongoing training of new operators, demonstrates proper techniques, provides coaching, tracks development, completes required documentation, and advises management of progress.
- Prepares daily departmental metrics for end-of-shift to assess team performance.
- Ensures the proper operation of process equipment in accordance with internal policy and procedure.
- Escalates information related to individuals who call in or arrive late to the line.
- Maintains accurate documentation and completes processing records.
- Dresses in accordance with internal policy detailed in operating procedures.
- Supports training as needed and acts as a Quva advocate to promote a positive culture.
Requirements
- High school Diploma or GED from a recognized institution or organization.
- 1+ years’ pharmaceutical manufacturing experience or labeling and/or packaging experience.
- Train-the-trainer qualified.
- Must pass a color perception exam and vision exam (20/20 vision with or without correction).
- Ability to work competently on all lines.
- 18+ years of age.
- Able to successfully complete a drug and background check.
- Must be currently authorized to work in the United States on a full-time basis; Quva will not sponsor applicants for work visas.
Qualifications
- Understands and adheres to all company policies and procedures, including operating standards; applies new standards when updated.
- Good time management skills and uses time productively.
- Recognizes priorities and takes appropriate follow-up action.
- Strong written and verbal communication skills, including presentation skills.
- Interacts with co-workers on various teams and at various levels to achieve desired outcomes.
- Continually strives to improve efficiency without compromising quality.
- Creates/revises training plans to meet specific objectives, including milestones and consideration of resources.
- Good decision-making skills.
- Mechanically inclined and engaged in implementing innovative technologies.
- Proficient with MS Office (Word, Excel, PowerPoint).
- Familiarity with basic operation of ERP systems.
Benefits
- Comprehensive health and wellness benefits including medical, dental, and vision.
- 401k retirement program with company match.
- 17 paid days off plus 8 paid holidays per year.
- Occasional weekend and overtime opportunities with advance notice.
Pay
Not specified.
Schedule
- Full-time role for 1st shift, Monday through Friday from 5:30 AM to 3:00 PM.
- Set, consistent schedule with minimum overtime requirements.
This is a safety-sensitive position that may be subject to random drug testing, in accordance with applicable laws. Based in Sugar Land, TX.