Top 2831 Director process validation Jobs

Biorepository Operations Director
Confidential —Arlington, VA
- Weekends as needed
- Hybrid work
- Background check
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- 3 years
Quick Apply
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Syncromune —Remote
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Director, Software Validation
STAAR Surgical —Lake Forest, CA
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Associate Director, Process Validation
Vaxcyte —San Carlos, CA
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Sr. Director, Quality Assurance for Quality Control
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Director Consumer Insights
Bimbo Bakeries USA —Irving, TX
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Senior Director / Director - CMC/GMP Quality Assurance
Semnur, Inc. —Palo Alto, CA
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Director, Strategic Initiatives
Mitsubishi Electric US, Inc. —Remote
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Director, Clinical Research Quality Assurance and Regulatory Support
Seattle Children's Hospital —Seattle, WA
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Clinical Operations Enablement & Systems Director
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Kardion —Remote
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- 6 years
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Associate Director, Process Validation and Tech Transfers
Wave Life Sciences —Lexington, MA
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- Full-time
- 8 years
- Doctor of Philosophy
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Biorepository Operations Director

Confidential
Arlington, VA

Quick Apply

Job Details

Full-time

Qualifications

Vendor relationship building
Biological safety protocols
Fertility & andrology care
Chemical handling safety procedures
Records maintenance
Standard Operating Procedures (SOPs) implementation
Spreadsheets
Microsoft Office
Cataloging
Team development
Bachelor's degree
Data management
Attention to detail
Quality control
Laboratory standard operating procedures
Health Science
Recruiting
Healthcare team management
Process improvement planning
Industrial chemical handling
Standard operating procedures (SOPs)
Staffing management
Chemical safety protocols
Standard operating procedures drafting

Full Job Description

Healthcare company is looking for a full-time Biorepository Operation manager for its DC metro area location.

The Biorepository Operation Director is responsible for the smooth and efficient day-to-day operations of a human specimen biorepository.

Major responsibilities include, but are not limited to, receiving and managing inventory of human specimens (semen, embryo, oocytes and tissue), maintaining clean and organized inventory records, managing specimen distribution and shipment to outside receiving labs, monitoring the function of the cryogenic alert systems, leading an emergency response team and managing an on-site team of cryogenic technicians.

Additionally, this position is responsible for improving the operational efficiency and safety protocols governing onsite operations including but not limited to process improvement, workflow review and optimization, systems evaluation and implementation, SOP development, training development and rollout.

This role will closely interact with the Client Services team as well as the laboratory teams across the country with respect to their biorepository- related operations.

Essential Job Responsibilities:

· Facility tank management, including specimen acquisition from internal production sites, external labs and distribution to other laboratory sites

· Leading all inventory record management & sample organization protocols

· Ensuring and maintaining a response protocol to cryogenic related system alarms

· Development and iteration of protocols governing site operations relating to cryogenic biorepository operations

· Oversight and management of daily QC/QA process, including managing the weekend coverage schedule

· Maintenance, validation and audits of on-site tanks

· Management of SOPs related to and ensuring safe handling of cryopreserved patient specimen

· Management of the cryogenics team (hybrid onsite and remote), including recruiting, training, coaching, setting the work schedule, performance evaluation and professional development

· End to end responsibility for the transport process, including coordination with medical couriers, coordination of staff workload to support, oversight of transport schedule, communication with our lab colleagues nationwide and management of external vendor relationships (ie. couriers, technology suppliers, etc) and cost oversight

· Receiving, cataloguing and maintaining accuracy of records in inventory management system

· Ordering supplies and equipment as authorized, and monitors needs to ensure continuous supply as required to maintain safe operations

· Ensuring that cryogenic safety practices are always followed

· Controlling costs and contributing to the annual budgeting process

· Developing OKRs for the team, including measurement and tracking of performance

· Maintains staff by recruiting, selecting, orienting, and training employees and developing personal growth opportunities.

· Additional responsibilities as deemed necessary

Experience Required:

· Bachelor’s degree in science, health science or another relevant field required

· Lab or Tissue Bank experience is required (recommended minimum of 3 years)

· Experience handling and managing cryopreserved human specimen and related records

· Experience of hiring, training and managing a team for a minimum of 3 years

Preferred

· Facilities management experience

· Fertility industry/Embryology experience

Knowledge & Skills Required:

· Excellent organizational and record keeping skills

· Extremely high attention to detail

· Critical thinking skills

· Demonstrated commitment to quality and excellence

· An eye for and a desire to design/implement continuous quality, safety and process improvements

· Excellent verbal & written communication skills

· Flexibility, open-mindedness and willingness to change opinions when presented with new information

· An interest in and aptitude for people management, personal development and growth

· Excellent multi-tasking abilities

· Ability to plan and prioritize work while responding flexibly to rapidly changing needs

· MS Office Proficiency. Including Excel and comfort with data

· Flexibility with schedule. Availability after hours and occasional weekends if needed

Physical Demands:

Ability to safely lift, carry, and maneuver liquid nitrogen tanks weighing up to 35 lbs., with or without reasonable accommodation

Work Environment: This job operates within a cryogenic storage facility. This role routinely uses equipment such as cryogenic liquids, which are extremely cold liquids that would be gas in a normal temperature and pressure environment. Adequate knowledge of the hazards of handling cryogenic liquids and proper handling techniques. Potential exposure to bodily fluids, blood borne pathogens, electrical, mechanical, laser, chemical and infectious hazards may occur.

This healthcare company offers a great salary; benefits package and much more!

To apply, please send your resume and cover letter via the Indeed apply button and note BOM in the subject line.

Application Question(s):

Do you have prior facility tank management experience with nitrogen tanks?

Education:

Bachelor's (Required)

Experience:

QC/QA : 1 year (Required)
inventory record management : 1 year (Required)
SOP: 1 year (Required)

Work Location: In person

Quick Apply

Refine Your Search

director process validation jobs

Biorepository Operations Director

Study Director

Director Quality and Performance Excellence

Director of Case Management

Associate Director, Clinical Trial Reporting

Customer Solutions Director

Director, Session Lead

Director, Quality Assurance (Quality Systems)

Director, Software Validation

Associate Director, Process Validation and Risk Management

Associate Director, Process Validation

Sr. Director Global Facilities Management

Sr. Director, Quality Assurance for Quality Control

Director Consumer Insights

Senior Director / Director - CMC/GMP Quality Assurance

Director, Strategic Initiatives

Director, Clinical Research Quality Assurance and Regulatory Support

Clinical Operations Enablement & Systems Director

Director of Procurement

Associate Director, Process Validation and Tech Transfers

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