JOB SUMMARY
Facilitates and supervises production Processes in support of the Production Supervisor or Manager including, a variety of tasks associated with the manufacturing of Werfen products.
KEY ACCOUNTABILITIES
- Provides guidance to Red Cell Processing staff members for daily lab operations.
- Trains new and incumbent staff members to achieve competency in lab functions and maintains up-to-date training records.
- Assists Manager and Supervisor with staff evaluation and development.
- Maintains department morale and employee motivation in a positive work environment.
- Monitors and maintains critical inventory of required supplies, components and raw materials.
- Assists in scheduling and performance of special projects and validation activities within the department.
- Performs blood processing operations according to corporate policies, operating procedures, specifications, and work instructions.
- Ensures blood products are transported, processed, and stored in a manner that prevents contamination.
- Follows appropriate control measures to prevent mixing of dissimilar production components in compliance with Good Manufacturing Practices.
- Performs in-process testing and visual inspections of product for defects.
- Creates legible written processing records that initiate product Batch Records and comply with all procedures and Good Documentation Practices.
- Follows applicable laboratory & OSHA regulations with respect to hazards and blood-borne pathogens.
- Maintains a neat, clean, and orderly work environment.
- Independently performs equipment setup, operation, re-supply, documentation, cleaning, minor adjustments and minor maintenance tasks to meet standards for safety, quality, reliability, and efficiency.
- Applies FDA regulations, and ISO standards to department operations and understands consequences of non-conformance.
- Moves, stores, and inventories production supplies and materials according to department specifications.
- Completes all training and qualification requirements; actively participates in on-going training and the training of new employees.
- Assist and communicate with co-workers to assure all safety, quality, and efficiency objectives are achieved.
- Demonstrate supportive behaviors towards co-workers and cooperate as a member of the team.
- Demonstrate behaviors supportive of personal and professional growth of self and co-workers.
- Assist with SOP revisions.
- Assists department improvements and validation activities.
- Serves as RBC Processing Department representation when designated by management.
- Assist with accurate inventory for the department.
- Supports and performs review of Manufacturing DHRs for RBC Processing, Solid Phase, VLP, Serum Bulk Manufacturing, and cleaning and maintenance records as needed.
- Performs BAAN entries (Production Orders, Material Transfers, BOMs) and data entry support, as needed.
- Assists in the development of metrics which help track manufacturing departmental outputs and effectiveness.
- Performs other duties as assigned by RBC Processing Management.
- Performs other duties and responsibilities as assigned.
MINIMUM KNOWLEDGE & EXPERIENCE REQUIRED FOR THE POSITION:
Education: Degree/ diploma obtained, program of study or equivalent.
EXPERIENCE:
Ability to speak, read and write English
Management has the discretion of substituting relevant work experience for a degree and/or making exceptions to the years of experience requirement.
Ability to work irregular hours as necessary to meet production schedules, assigned work shift, and occasional overtime, preferred.
Skills & Capabilities:
- Leadership & Team Guidance – Ability to supervise daily operations, support staff development, and maintain team morale.
- Technical Proficiency in Blood Processing – Knowledge of red blood cell processing, aseptic techniques, and cleanroom protocols.
- Regulatory Compliance – Understanding and application of GMP, GDP, FDA, ISO, and OSHA standards in a production environment.
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
Linked-in
Google