Supervisor, Manufacturing AID

Werfen

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 7000 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. Were passionate about providing healthcare professionals the most valuable and complete solutions to improve hospital efficiency and enhance patient care.

Position Summary:

Inova Supervisors are responsible for overseeing the daily activities of their assigned team. This position is responsible for planning scheduling and distributing work assignments for the manufacture of Inova products while meeting productivity standards quality goals and department objectives. Responsible for resolving operational and performance issues and recommending improvements to operations processes and the work environment. Works closely with direct reports and other departments daily. Communicates and collaborates with staff department leadership and other Inova staff to meet goals and produce the highest quality products and services. Ensures all staff are meeting Inova policies and administrative expectations. Activities are performed in accordance with standard operating procedures (SOPs) Quality Systems Regulations (QSRs) safety and administrative regulations.

Key Accountabilities

Essential Functions:

• Supervises daily manufacturing activities carried out by the team/department in compliance with Standard OperatingProcedures (SOPs) and other quality systems requirements which may include but is not limited to:
  • Preparation of bulks and solutions
  • Evaluation of raw materials in-process materials and finished reagents
  • Development and compliance to master validation plans and ensuring applicable process and equipment validation protocols are developed executed and maintained as applicable.
  • Maintenance and review of laboratory notebooks and and/or any associated documentation for manufacturing evaluation and development activities.
  • Research and correction of production issues.
  • Set-up calibration validation operation cleaning and maintenance of laboratory equipment as applicable.
  • Creation approval and implementation of Engineering Change Orders (ECOs) for manufacturing documents and SOPs.
• Monitors operations to identify evaluate and implement operational changes to improve performance service productivity costs etc.
• Works with staff to assign tasks answer questions make decisions and resolve issues as they occur to ensure smooth daily operations.
• Plans and monitors the flow of work into and through the team/department to ensure adequate materials and resources to meet productivity quality and service expectations.
• Trains and communicates with direct reports to ensure expectations are clear and staff comply with Quality Systems and administrative policies and guidelines.
• Ensures all required documentation is completed in accordance with Quality Systems Regulations (QSRs).
• Investigates analyzes and carries out corrective actions to maximize product performance or to resolve manufacturing problems under the direction of department management.
• Writes and revises SOPs. Responsible for Engineering Change Orders (ECOs) for department documents SOPs Work Instructions and other Quality Systems documents.
• Communicates and collaborates with other departments people managers and staff to ensure smooth and efficient operations.
• Assists with staffing decisions to ensure a high performing team; including interviewing selecting training and developing staff.
• Manages department schedules to ensure department goals are achieved; responsible for approving schedules time off overtime and timekeeping reporting.
• Carries out performance management and development activities including setting expectations and providing meaningful feedback. Provides opportunities for development where possible. Proactively manages employee relations issues; uses judgement in consulting with department leadership and Human Resources.
• Maintains regular and transparent communications throughout department through effective use of one-on-one meetings team meetings and other forms of formal and informal communications.
• Responsible for staff training to ensure competency. Ensures staff compliance to training requirements.
• Educates and supervises staff to ensure compliance with applicable Inova SOPs ISO FDA and other Quality System Regulations as well as applicable Environmental Health & Safety Human Resources and all other regulatory and administrative policies.
• Reflects the company values and serves as a role model to staff and customers.

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

Budget Managed:

• Supports department budget indirectly by managing expenses effectively

Internal Networking/Key Relationships:

• Planning team
• Quality Control
• Technical Support
• Research & Development including Manufacturing Technical Service (MTS)
• Biochemistry team
• Quality Assurance
• Purchasing
• Marketing

Competencies:

• Werfen People Manager Competencies: Building talent Customer focus Decision making Driving for innovation Driving for results Emotional intelligence.
• Werfen Values: Integrity Leadership and Delivery of Results
• Establish productive relationships within sphere of influence
• Coach team members for immediate and future success
• Demonstrate sounds reasoning and problem-solving ability
• Initiative to recognize and act upon opportunities to improve the lab/product
• Contribute to the appropriate disposition of product
• Provide educated well informed council to management

Minimum Knowledge & Experience Required for the Position

Education:

• Bachelors degree in biology or related sciences required.

Experience:

• 5 years of experience in a regulated laboratory setting required; preferably in immunology or medical device manufacturing.
• 3 years of experience leading or supervising a team required within life sciences preferred.

Skills & Knowledge:

• Excellent knowledge of laboratory skills including solution preparation bead-based assay manufacturing procedures and laboratory equipment operation. Knowledge of Quality Systems Regulations (QSR) and Engineering Change Orders (ECO) systems as they apply to diagnostics manufacturing.
• Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written oral diagram or schedule form. Ability to deal with several abstract and concrete variables in defining problems collecting data establishing facts and determining valid conclusions.
• Experience with Enterprise Resource Planning (ERP) systems required SAP strongly preferred.
• Demonstrated experience with standard administrative and business procedures required.
• Proven track record of organizing and supervising successful operations and teams required.
• Ability to build consensus and relationships among peers stakeholders and employees required.

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

International Mobility:

• No

Work Environment:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. While performing the duties of this job the employee is regularly required to communicate. Must be able to detect identify and inspect scientific data. The employee will be required to stand and/or walk up to 8 hours per day and/or sit for up to 8 hours per day. Must be able to use hands to feel objects including keyboard telephone and pipettes or other lab equipment. May need to reach with hands and arms climb stairs balance stoop kneel or crouch. Will be required to talk and hear and have specific vision abilities including close vision distance vision color vision peripheral vision depth perception and ability to adjust focus. May occasionally have to lift and/or move up to 25 pounds. The noise level in the work environment will vary but is usually moderate. This position is very active and requires varying levels of mobility.

Travel Requirements:

• <5% of time

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 individuals 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 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 7000 employees around the world comprise our Werfen team.