OverviewPosition 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.
ResponsibilitiesKey Accountabilities:- 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.
QualificationsMinimum 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
