Job Information
About the Position
Introduction
Werfen is a growing, family-owned, innovative company founded in 1966 in Barcelona, Spain. We are a worldwide leader in specialized diagnostics in the areas of Hemostasis, Acute Care Diagnostics, Transfusion, Autoimmunity, and Transplant. Through our Original Equipment Manufacturing (OEM) business line, we research, develop, and manufacture customized assays and biomaterials. We operate directly in 30 countries, and in more than 100 territories through distributors. Our Headquarters and Technology Centers are located in the US and Europe, and our workforce is more than 7,000 strong.
Our success comes from a specific focus in these rapidly evolving diagnostic areas, our commitment to customers, and our dedication to innovation and quality. We’re passionate about providing healthcare professionals the most valuable and complete solutions to improve hospital efficiency and enhance patient care.
Overview
Job Summary
The Supervisor of VLPCC (Vialing, Labeling , Packaging and Controlled Components)is responsible for ensuring the consistent execution of departmental procedures, maintaining high standards of product quality, and supporting day-to-day manufacturing activities in compliance with cGMP, GDP, and safety standards. This position requires strong technical knowledge, leadership skills, and a commitment to continuous improvement in all facets of production.
- This position serves as the bridge between strategic leadership and hands-on execution, ensuring that every batch processed adheres to the highest regulatory, safety, and performance standards.
- Supervises the day-to-day activities in the Preproom, Packaging and Controlled Components areas to ensure conformance to department, company, and FDA guidelines and regulations.
- This position uniquely combines technical manufacturing knowledge, team leadership, and quality oversight to ensure that both people and processes are operating at peak performance.
Responsibilities
Key Accountabilities
- Ensure all VLPCC (Vialing, Labeling, Packaging and Controlled components) processing operations are performed accurately, efficiently, and in compliance with established SOPs, cGMP, and safety regulations.
- Lead, mentor, and support team members to meet daily production goals while promoting a culture of accountability, quality, and continuous improvement. Lead and assist in training and cross-training activities.
- Review, revise, and approve documentation, including manufacturing records, deviation reports, and quality control logs, to ensure data integrity and regulatory compliance. Assists with CAPAs, Change Controls, and Special projects/tasks as required.
- Monitor workflow and resource allocation to optimize efficiency and minimize downtime across shifts and operations.
- Serve as a first-line responder to operational issues, deviations, and product nonconformances, implementing corrective actions and escalating as needed.
- Collaborate cross-functionally with Quality, Supply Chain, Engineering, and other departments to ensure production timelines and quality expectations are met.
- Maintain accurate inventory levels, generate purchase requests, and ensure equipment and materials are available and operational to support processing activities.
- Track team and departmental performance using KPIs and quality metrics to identify trends, drive improvements, and meet organizational objectives.
- Support onboarding and cross-training efforts to build a flexible, knowledgeable, and resilient production team.
- Performs employee annual performance evaluations. Assists with cycle counts, maintains accurate inventory, and completes monthly and quarterly inventory.
- Lead triages for the department and initiate solutions to prevent reoccurring issues.
- Show the utmost commitment to Quality and Safety at all times.
- Performs other duties and responsibilities as assigned.
Networking/Key relationships
Works closely with other production (manufacturing) members, quality control, quality assur-ance, customer service, shipping, sales and marketing staff. Follows appropriate control measures to ensure segregation of dissimilar Red Cell components or other products. Follows applicable laboratory OSHA safety regulations concerning chemical hazards, blood-borne patho-gens, etc. Understand FDA regulations and ISO standards relevant to department operations and consequences of non-conformances.
- Production Technicians: Provide daily direction, coaching, and support to ensure consistent workflow and adherence to SOPs.
- Quality Assurance (QA): Collaborate to address deviations, approve records, and implement CAPAs for regulatory compliance.
- Quality Control (QC): Coordinate timely quality checks, data review, and resolution of product discrepancies.
- Supply Chain & Inventory Management: Communicate material needs, coordinate inventory cycle counts, and support timely replenishment of critical supplies.
- Engineering & Maintenance Teams: Work jointly to schedule preventive maintenance, address equipment malfunctions, and ensure equipment readiness.
- Training & Compliance Personnel: Partner to deliver onboarding and continuous training, ensuring employee qualifications and up-to-date compliance.
- Cross-Functional Leadership: Engage with cross-departmental leaders to align on production schedules, resource allocation, and continuous improvement initiatives.
Qualifications
Minimum Knowledge & Experience required for the position:
Education:
- Bachelor’s degree (BS/BA) from a four-year college, university, or equivalent combination of education and experience.
- Preferred: Aseptic technique and Aseptic gowning.
- 2 years experience in a regulated manufacturing environment such as medical devices, pharmaceuticals, biotechnology, or blood banking.
Experience:
- Demonstrated Managerial skills, including: planning and delegation, decision making and problem solving, budget management, performance management, conflict resolution, employee development and coaching.
Skills & Capabilities:
- Strong understanding of cGMP, GDP, and FDA regulatory requirements within a manufacturing environment.
- 2+ year minimum of previous supervisory and team-building skills with the ability to coach, motivate, and hold team members accountable.
- Knowledge of Lean Six Sigma or continuous improvement methodologies. Committed to excellence and high standards.
- Excellent organizational and time management abilities to coordinate multiple priorities under tight deadlines.
- Effective communication skills, both written and verbal, for cross-functional collaboration and documentation review.
- Competence in reading and interpreting SOPs, batch records, and regulatory documents.
- Ability to perform basic mathematical calculations, including percentages, ratios, and unit conversions.
- Proficient in problem-solving and root cause analysis to resolve manufacturing and quality-related issues.
- Capable of operating standard production equipment and performing aseptic techniques accurately.
- Strong attention to detail to ensure data accuracy, product integrity, and procedural compliance.
- Computer literacy with ability to navigate ERP systems and Microsoft Office applications (Word, Excel, Outlook).
- Must be available to work irregular hours as necessary to meet production schedules with occasional overtime.
Travel requirements:N/A
If you are interested in constantly learning and being challenged on a daily basis we encourage you to submit your resume or CV. Werfen is an Equal Opportunity employer and is committed to a diverse workplace. Werfen strictly prohibits unlawful discrimination, harassment or retaliation based upon an individual’s race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other protected characteristic as defined by applicable state or federal law. If you have a disability and need an accommodation in relation to the online application process, please contact NAtalentacquisition@werfen.com for assistance.We operate directly in over 30 countries, and in more than 100 territories through distributors. Annual revenue is approximately $2 billion and more than 7,000 employees around the world comprise our Werfen team.www.werfen.com
