Technical Team Leader - Quality Control

Werfen; Orangeburg (SC); On-site; USD 80,000 - 100,000; Full time

Job summary

Werfen, located in Orangeburg, South Carolina, is seeking a qualified candidate for a technical role in a production environment. The position involves supervising a team to ensure performance aligns with plant goals and supporting investigations to solve technical challenges.

The ideal applicant will have a Bachelor's degree in life sciences or relevant certification, along with at least 5 years of experience in a regulated laboratory environment. The salary range is $80,000 to $100,000 annually.

Qualifications

• Minimum of 5 years progressive experience in a laboratory or Quality Control environment.
• Experience within a regulated medical device manufacturing or In-Vitro Diagnostic Device (IVDD) is a plus.
• Minimum of 2 years supervision experience.

Responsibilities

• Develops daily schedules for areas of responsibility.
• Manages resources to accomplish established goals of quality, quantity, and cost.
• Supervises team compliance with all company policies.
• Prepares operating and capital budgets accurately.
• Reviews monthly financial reports.
• Ensures appropriately staffed team with trained employees.
• Maintains and operates equipment safely.
• Establishes objectives for areas of responsibility.
• Identifies department training needs and implements training measures.

Skills

Understanding of Good Manufacturing Practice (GMP)

Demonstrated ability to organize work assignments

Knowledge of laboratory equipment, QC Instruments

Proficiency in common laboratory techniques

Basic management knowledge

Technical writing skills

Knowledge of QC testing procedures

Previous regulatory audit experience

Employee relations

Business acumen

Oral and written communication skills

Education

Bachelor's degree in a life sciences or certified Medical Technologist (MT)/Medical Laboratory Scientist (MLS)

Job description

About the Position

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

Position Summary:

Responsible for a technical function in a production environment. Provides direction and support for team ensuring that team performance aligns with plant goals. Uses technical expertise to support investigations and solve challenges. Generally supervises a team that is focused on common activities. Works independently on many areas of responsibility, but involves supervisor in significant operations, technical and/or management issues.

Responsibilities

• Working with buyer/planner or manager, develops daily schedules for areas of responsibility to conform with monthly requirements defined by master scheduler/Plant requirements
• Manages resources to accomplish established goals of quality, quantity and cost. Interfaces effectively with other Team Leaders to allocate resources between teams, as needed
• Supervises and ensures team compliance with all company policies, including safety, health, QSR, and ISO standards
• With assistance from supervisor, prepares operating budget and capital budget for areas of responsibility accurately and on schedule
• Reviews monthly team/departmental financial reports to ensure that spending is within budget and provides corrective action and explanations as needed
• Ensures that team is appropriately staffed with trained employees
• Ensures that equipment is maintained and operated safely and efficiently
• With assistance from supervisor, establishes objectives and strategies for areas of responsibility that complement plant and ISO objectives
• Identify department training needs and implement appropriate training measures; mentor and train staff to enhance both individual and department
• Continuously analyzes operations in an effort to reduce costs and improve quality
• As requested by supervisor, prepares and submits an accurate, timely monthly report
• Establishes effective working relationships with other Team Leaders/Managers to ensure that plant objectives are met
• Responsible for the performance management process for staff
• Sets a personal example of behavior and commitment to company values and plant objectives to encourage a high level of morale and teamwork for all employees
• Creates and maintains measurements for the team's performance (Daily/monthly goals, inventory accuracy, backorders, etc.)
• Responsible for initiation of Nonconformance Reports as required
• Responsible for QC House Standards - selection of, crossover studies, data summaries, inventory, performance and trending (QC)
• Propose solutions or recommend actions for resolution of technical issues
• In conjunction with the Training Coordinator, responsible for employee technical training plans
• Performs other duties and responsibilities as assigned.

Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions.

The annual salary range Werfen reasonably expects to pay for the position is $80,000 to $100,000. Compensation is reasonably based upon multiple factors including education, relevant experience, skillset, knowledge, and specific needs of the business.

Qualifications

Minimum Knowledge & Experience for the Position:

• Education: Bachelor's degree in a life sciences, or certified Medical Technologist (MT)/Medical Laboratory Scientist (MLS).
• Experience: Minimum of 5 years progressive in a laboratory or Quality Control environment, experience within a regulated medical device manufacturing or In‑Vitro Diagnostic Device (IVDD) is a plus with a minimum of 2 years supervision.

Management has the discretion of substituting relevant work experience for a degree and/or making exceptions to the years of experience requirement.

Skills & Capabilities:

• Understanding of Good Manufacturing Practice (GMP), Good Laboratory Practices (GLP)
• Demonstrated ability to organize work assignments
• Knowledge of laboratory equipment, QC Instruments
• Proficiency in common laboratory techniques
• Basic management knowledge
• Technical writing skills, including ability to write protocols, test procedures and other technical reports and documents
• Knowledge of QC testing procedures
• Previous regulatory audit experience a plus
• Employee relations
• Business acumen
• Oral and written communication skills

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 [e-mail] for assistance.