The Lab Operations Supervisor is responsible for overseeing the performing processing/manufacturing activities of the team members and ensuring equipment, supplies, and method used for processing are properly performed, maintained, and ready for use while leading by example, enforcing quality, and complying with Quality Assurance requirements as mandated by federal (FDA), state, and AATB regulations.
Specific Duties:
Completes duties and responsibilities as Lab Operations Supervisor in addition to the following:
· Enforce quality and helps team members perform the technical aspects using best practices for the industry.
· Overseas the processing of perinatal tissues into HCT/Ps.
· Assist Lab Operations Manager with interviewing process of new processing technicians.
· Oversee training of new processing technicians.
· Sign off on completion of employee training (Training Qualifications)
· SME for most, if not all programs and product lines
· Demonstrate proficiency in technical writing, ability to draft detailed and compliant SOP's and Change Controls
· Participation in QA and Ops meetings as required to maintain department communication and compliance with assigned program in which employee is responsible.
· Management of Processing Technicians, including at a minimum:
o Manage Production Schedule
o Manage time-off requests, ensuring the proper staff is available to complete production and other activities assigned by Lab Operations Manager
o Periodic review of direct reports to ensure they are progressing in their respective role
o Maintain accountability of Processing Technicians to ensure any individual performing tasks is properly trained
o Assign Performance Improvement Plans as necessary for Tech's not adhering to processes and procedures
· Investigation and drafting, and/or reviewing of Deviations, CAPA's, OOS's
· Responsibility to ensure any corrective/preventative actions created through above processes are complied with regulatory and internal SOPm standards
· Ensure cross-functional training and activities for QA department are up-to-date and created
· Responsible for other duties and projects as assigned.
Education and Experience Required:
· Experience and knowledge in aseptic technique.
· Bachelor's degree in science or related field or Associate degree with 1 or more years of relevant experience.
· Attention to detail with neat and legible handwriting.
· Experience in a GMP manufacturing environment.
· Multi-tasking in a fast-paced environment.
· Proficient in Microsoft Word, Excel, and Outlook. PowerPoint is a plus.
· Strong analytical, planning, critical thinking, and troubleshooting skills.
· Ability to effectively communicate and lead by example.
· Results oriented with a high level of initiative.
Language Skills:
· Ability to write reports in the English language.
· Ability to effectively present information and respond to questions from team members, groups of supervisors and/or managers.
Mathematical Skills:
· Ability to calculate figures and amounts such as proportions and percentages.
· Ability to apply concepts such as fractions, percentages, ratios, and proportion to practical situations.
Reasoning Ability:
· Ability to solve practical problems and handle a variety of concrete variables in situations where only limited standardization exists.
· Ability to interpret a variety of instruction furnished in writing, oral, diagram, or schedule form.
· Ability to define problems, collect data, establish facts and draw valid conclusions.
· Strong analytical, numerical, and reasoning abilities.
· Well-developed interpersonal skills
· Participative work style
· Ability to established credibility and be decisive
· Good communication skills, written and verbal.
Certificates, Licenses, Registrations
ASQ, CQ, CRE, CTBS and /or CQT Certificates are desirable
Physical Demands:
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 Reasonable Accommodations may be made to enable individuals with disabilities to perform the essential functions.
· While performing the duties of this job, the Employee is regularly required to sit for long periods of time; walk, climb stairs, stand; use hands to handle, or feel; reach with hands and arms; and talk and hear.
· The Employee must regularly lift and/or move up to 10 pounds and occasionally lift and /or move up to 40 pounds.
Work Environment and Environmental Conditions
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.
· Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions
· The noise level in the work environment is usually moderate
· The environment is primarily a laboratory production environment with some warehouse duties
· While the building having heating and air conditioning, frequent opening of the roll up doors may affect the efficiency of the HVAC system
· There is some limited exposure to physical risk and blood born pathogens.
PPE Requirements
Scrubs required when working in the operations area
Foot apparel mush cover all portions of the foot
Other PPE such as gloves, sleeves, aprons and/or gowns may apply when inspecting equipment in the operations area.
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