Lead Production Technician and Trainer - ILP 1st Shift

Quva • Sugar Land, TX

4d • Onsite

About The Position

Our Lead Production Technician and Trainer - ILP plays a vital role within our organization. Once you complete our training, your responsibilities will oversee the planning, scheduling, staffing, and daily execution for the inspection, labeling, and packaging of compounded sterile products (CSPs) and bulk bags, and non-sterile solutions. This position is also responsible for training ILP technicians in daily activities for controlled and non-controlled operations, including but not limited to:

Defect Recognition and Inspection Procedure
Inspecting Various Primary Containers including Syringes, Bags, PCA Vials, and CADDs.
Proper Labeling of Primary and Secondary Packaging
Proper Packaging of Primary and Secondary Packaging
Proper Use of Automated Equipment in the ILP areas
Batch Records Good Documentation Practices

As part of this role, the Lead/Trainer will need to ensure proper line controls are maintained, that appropriate documentation is available, and that batch records and corresponding training documentation are completed on time. The Lead/Trainer will need to ensure that people are operating within safety requirements, current Good Manufacturing Practices (21CFR210 and 211), company policies and procedures.

In partnership with the site leaders sponsors a safety, quality and compliance focused site culture which embraces RFT (right first time) and CI (continuous improvement) expectations.

Your attention to detail and adherence to precise procedures will guarantee that our medications meet the highest standards of safety, efficacy, and quality, providing patients with the best possible care and outcomes. Turn your passion for precision and your commitment to quality into a meaningful impact on healthcare across the US.

Requirements

• High school Diploma or GED from recognized institution or organization required
• At least 1-year pharmaceutical manufacturing experience or labeling and/or packaging experience
• 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 is not able to sponsor applicants for work visas

Nice To Haves

• BA degree preferred, but not required
• Has a sense of urgency, accountability and resourcefulness (e.g., work in changing environment)
• Is a self-starter and independent learner
• Promotes active listening with team members; Contributes appropriately to conversations; Has strong verbal and written communication skills with the ability to work effectively with other departments within the organization and with people at all levels of the organization
• Understands how various issues affect each other and the outcome of projects; Improves upon existing approaches by seeking opportunities to creatively transform

Responsibilities

• Coordinate and deliver new employee orientation
• Oversees inspection, labeling, and packaging operations, including scheduling, processing, and completion of finishing activities in support of CSPs, and non-sterile solutions
• Supports development of weekly ILP plans and schedules based on skills and competencies of technicians coupled with established training plans
• Ensure all the safety rules and policies are always followed
• Conducts initial and on-going training of new operators, demonstrates proper techniques, provides coaching, tracks development, completes required documentation, and advises management of progress; regularly attends training meetings
• Serve as a knowledgeable resource for any team member who needs assistance with products or procedures as well as SME for cross-functional project teams
• Track and document training and communicates any deficiencies to Operations Management
• Actively participates in training and implementation of new equipment
• Prepare individual training plans, monitor progress against individual training plans
• Propose effective methods of training and perform verification and effectiveness checks in conjunction with the completion of individual training plans
• Interface with corporate and site support functions regarding training priorities and initiatives
• Coordinate and assure subject matter experts are available to support on the job training
• Provide counsel and recommend enhancement to training plans and processes
• Ensures Competency Assessments are performed with employees as required
• Identify process improvements and promote an environment of continuous improvements
• Complete necessary documents for accountability and traceability of product following Good Documentation Practices (GDPs); Comply with cGMPs, and company ISO standards
• Communicates effectively to Operations, Quality and other functional support staff
• Ensures timely communication and coordination of activities to ensure materials are transported and processed per internal procedures to meet established timelines for delivery and internal processing
• Familiarity with basic operation of ERP systems
• Maintains accurate documentation and complete processing records
• Resolves and escalates non-routine incidents immediately
• Be a Quva advocate and promote a positive culture

Benefits

• Set, full-time, consistent work schedule
• 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
• National, industry-leading high growth company with future career advancement opportunities

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: High school or GED