Manufacturing Laboratory Manager

A Manufacturing Laboratory Manager job in Oklahoma City, OK is available through Adecco Medical and Science. As a Manufacturing Laboratory Manager, you will be responsible for management and control of all daily manufacturing operations for the Component Manufacturing and QC lab, including all staff, budgets, environment and work processes. Ensure compliance with regulatory compliance with all regulations in accordance with AABB, CLIA, federal, state, OBI policies and procedures. Assure compliance with safety policies and procedures in the work area and use of applicable protective equipment at all times to prevent exposure to potentially infectious blood and body fluids. Manage blood component product manufacturing based on inventory and customer needs.

Primary responsibilities include:

Ensure compliance with federal, state, AABB, CLIA and OBI directives and regional policy and procedures and regulations.
Coordinate the implementation of new or revised tests, procedures, and equipment with SOPs, CFR regulations.
Effectively supervise product manufacturing activities to ensure appropriate products are manufactured based on OBI inventory reports and special order requests.
Manage and evaluate workflow and processes to ensure efficient and streamlined manufacturing processes to meet customer demand and required timelines. Implement cost saving and process improvement initiatives.
Responsible for tracking and trending and analysis of laboratory data and the generation of reports and metrics.
Ensure appropriate manufacturing of blood components.
Ensure appropriate labeling, product reconciliation.
Ensure maintenance is performed as appropriate.
Lead and assist in the overseeing of software used for QC and Component Manufacturing.
Establish a QC system for manufactured products as well as manufacturing devices.
Assist in product failures investigation and ensure root cause and corrective action are followed.
Participate in documenting, investigating, troubleshooting and preventing recurrence of department problems, concerns, and complaints.
Ensure laboratory training and annual competency assessments are completed in compliance with established guidelines in the OBI training system.
Coordinate and assist change control for systems, processes and procedures.
Perform supervisory review of documents.
Maintain a high standard of integrity and confidence in all communication with staff and volunteers.
Responsible for the management of laboratory staff including, but not limited to, hiring, training, coaching, evaluating and disciplining to ensure a well-qualified team and to enhance operational success and compliance.
Direct management of staffing and scheduling including hiring.
Assure that all team members comply with all applicable compliance and safety directives and regulations.


Secondary Responsibilities:


Oversee levels of and ordering of all supplies in each department.
Investigation of monthly product loss report
Other projects as assigned
Perform Quarantine Management activities as needed.
Aid Technical Writer in authoring of SOPs as needed.


Required Licenses, Certifications


Must maintain knowledge of regulatory requirements concerning validation, calibration, quality control, and maintenance of equipment and supplies used at Oklahoma Blood Institute.
Must have a working knowledge of blood and tissue center procedures and equipment.
Must maintain knowledge of and perform according to Standard Operating Procedures (SOPs) and policies.




Education, Experience, Knowledge, Abilities


Position requires a Bachelors of Science from an accredited institution in chemical, physical, biological or clinical laboratory science. A higher degree is preferred.
2-5 years supervisory experience.
Must have excellent supervisory, planning and organizational skills.
Must have strong leadership skills and professional appearance and demeanor.
Must have excellent written and oral communication skills.
Strong computer skills are required.
Project management experience preferred.
Must be professional, detail oriented, self-motivated, innovative, creative, assertive, organized, communicative, and have the ability to work independently.
Must maintain good working rapport with all departments.
Must be able to make decisions regarding operation of the department.
The duties are representative of the essential functions of the position. Operational flexibility is required to meet sudden and unpredictable needs. Available to work overtime, other shifts, early mornings, evenings, holidays and weekends.



If you are interested in this Manufacturing Laboratory Manager job in Oklahoma City, OK then please click APPLY NOW. For other opportunities available at Adecco Medical and Science go to www.adeccousa.com. If you have questions about the position or would like more information, please contact Sindie Rothstein at 858-410-1108 or by email at Sindie.rothstein@adeccona.com.

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