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Job Detail
Job Description
General Summary: Responsible to supervise all operational aspects of the department. Ensures all laboratory procedures are conducted in compliance with prescribed regulations. Exhibits leadership and supervises all technical activities to include training, evaluating individual performance, counseling, and providing testing assistance as necessary. Maintain knowledge of all current Standard Operating Procedures (SOPs) required to perform effectively. Maintain excellent communication with all personnel. Commit to and abide by the character of Green Key's client's Core Values of Accountability, Stewardship, Pioneer, Integrity, Respect and Excellence (ASPIRE). Support, communicate and reinforce the mission and vision of the enterprise. Provide world class customer service by capturing and being responsive to the voice of the customer (including donors) through established feedback channels in order to resolve issues and drive satisfaction in accordance with the customer engagement, feedback, and complaint processes. Must have a valid driver's license and be at least 21 years old with a good driving record to meet organization driving standards.
Major Duties and Responsibilities
Essential Tasks
- Supervise the overall activities and monitor the continuous flow of sample processing. Maintain a heavy presence within the Laboratory to ensure productivity, efficiency, and to reduce downtime. Manage a team in a high volume, fast paced environment.
- Maintain strict adherence to Standard Operating Procedures (SOPs), regulatory requirements, and all company policies.
- Competently perform all assigned departmental duties. Oversee Pre‐Analytical tasks (receipt, qualification, and preparation of samples for testing), highly complex Analytical testing on donors, and biologic products, and Post- Analytical tasks (exporting results, sample cataloguing, sample retention, and salvage).
- Evaluate results and equipment performance in an accurate and timely manner, and analyze quality control data. Ensure resolution of deviations prior to continuing testing.
- Participate in investigations to determine the root cause of deviations, complaints, and audit findings. Follow up with appropriate corrective actions pertaining to staff and/or following SOPs.
- Ensure appropriate investigation and follow up for customer service inquiries.
- Assure that departmental supplies are maintained within established inventory levels.
- Perform routine data entry, analysis, and prepare reports that measure and monitor laboratory performance.
- Approve equipment maintenance tickets and ensure staff compliance.
- Monitor staff performance and assign schedules. Train and/or mentor employees.
- Interview and make recommendations for hiring, terminating, promoting, demoting, evaluating, counseling, and salary changes for departmental personnel.
- Ensure turn-around-time and testing exceptions are managed in accordance with requirements.
- Lead team-oriented work projects for the development and implementation of validations, process improvements, and Standard Operating Procedures (SOPs) that align with strategic goals.
- Display positive leadership skills and champion management directives with department employees by committing to and embracing the mission, vision, and core values of Green Key's client:
- Be dedicated to the highest standards of quality and adhere to all safety, regulatory, and quality requirements.
- Foster an atmosphere of open, honest communication and knowledge sharing among workers in business units throughout the organization. Demonstrate respect for co-workers and management.
- Consistently improve performance outcomes in customer satisfaction, worker engagement (motivation and satisfaction), operational excellence, innovation, and financial performance.
- Maintain a positive work attitude and participate in self-improvement as an effective leader.
- Participate in continuing education and attend meetings as required.
- Always maintain a professional demeanor while representing Green Key's client. Assist with preparing and monitoring of the department budget.
- Perform other duties as assigned.
Non-Essential Tasks
- Assist in other areas as directed.
Education
- Requires a Bachelor’s Degree from an accredited four-year college or university. The required major is Applied Science [Official Military medical laboratory procedure course preferred] or Science, Engineering, Biotech, other technical field or equivalent.
Licenses and/or Certifications
- Georgia Operators Driver’s License
- Categorical Certifications preferred
- Certified Medical Technologist (MT)(CLS)/ MLT or equivalent preferred
Experience
- Requires four or more years of CLIA laboratory experience or experience within a GMP compliant facility. Requires two or more years of leadership/supervisory experience.
- Preferred experience in biopharmaceutical manufacturing.
Knowledge
- Must maintain knowledge of and perform according to Standard Operating Procedures (SOPs) and policies. Must maintain familiarity of regulatory/quality compliance, to include FDA, EU, ISO, GHM, cGMP, OSHA, etc.
- Must recognize and facilitate resolution of unusual results or difficulties encountered in all phases of laboratory work.
- Must have a working knowledge of laboratory techniques.
Skills
- Must demonstrate positive leadership skills.
- Must be capable of evaluating, interpreting and reporting accurate/valid test results by current testing methodologies.
- Must maintain competency in laboratory skills for liquid and material handling. Must be capable of operating motor vehicles in all types of weather conditions. Must have strong computer skills.
- Must have excellent written and oral communication skills.
Abilities
- Must be able to correctly interpret test results. Must be able to keep information confidential.
- Must be able to work with interruptions, meet deadlines, and perform accurate work and/or reports. Must be neat in appearance and well groomed.
- Must be professional, detail oriented, self motivated, innovative, creative, assertive, organized, communicative, and have the ability to work independently.
- Must perform well in repetitive work situations.
- Must work well independently and as a team member as well as facilitate organizational team activities.
Working Environment
- Works in a well lighted air conditioned and heated laboratory/department. Laboratory consists of complex setting with robotic instrumentation. May be exposed to electrical, mechanical and chemical hazards and other conditions common to a laboratory environment. May be exposed to blood borne pathogens and other conditions common to a clinical laboratory environment. May have bodily exposure to refrigerator/freezer temperature, especially hands and face. Will work extended hours during peak periods. May be required to work any time of the day, evening or night during the week or weekend to include being on-call. May be required to use personal motor vehicle for company business. May be required to participate in national and/or international travel. Occupational Exposure Assignment – Category I
Physical Requirements
- Must be able to drive on behalf of the organization.
- Will sit, stand, walk, and bend during working hours.
- Requires to reach, lift and carry up to 20 lbs.
- Requires manual and finger dexterity and eye-hand coordination.
- Requires normal or corrected vision and hearing corrected to a normal range.
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