SUMMARY
The Laboratory Supervisor is responsible for overseeing day-to-day laboratory operations, personnel, reagent production, validation activities, quality compliance, and laboratory safety. This position provides leadership to laboratory staff while ensuring efficient operations, regulatory compliance, and support of company quality objectives.
ESSENTIAL DUTIES AND RESPONSIBILITIES
- In coordination with the Quality Assurance Manager; interview, train and supervise personnel required to support the production of consumables in the laboratory and personnel required to support the validation of instruments.
- In coordination with the HR Manager; Coach, lead, and develop personnel to ensure organizational goals and objectives are met. Carry out supervisory responsibilities in accordance with ATI’s policies. Responsibilities may include: ongoing/annual training, performance evaluations, addressing/resolving complaints/problems. Ensure compliance with both federal, state and local laws, guidelines and best practices including those related to safety and health.
- Oversee Laboratory Technicians and Validators, and/or assists the Engineering and QC personnel when laboratory skills are needed to prepare reagents, or perform tests that advance the design, validation and/or production of a device.
- Oversee or perform CAP and other proficiency testing surveys.
- Assists with customer training and troubleshooting; answer customer’s questions about programming applications on ChemWell or other company products.
- Schedule and expedite production activities for orders placed, giving consideration to making the components, planning the timeline of the orders, and coordinating the products and materials needed for the orders.
- Oversees or prepares and logs the preparation of reagents used in the laboratory including QC dyes for in house use and dyes and reagents used in products that will be sold.
- Coordinate with the purchasing department to maintain inventory of materials to satisfy customer orders.
- Control and inspect expiration dates of inventory to control losses.
- Provide input, draft instructions for manufacturing/testing and product use (i.e. Owner’s Manual, Customer Instructions and/or applicable training documents).
- Assist and/or perform activities required to produce regulatory documents. e.g., FDA 510(k) submissions.
- Assist as needed in Safety, FDA, ISO and internal quality audits.
- Assures timely and accurate calibration and monitoring of measuring equipment.
- Perform activities to fulfill report requirements and record retention as established by ATI records retention policy.
- Analyze and suggest selected purchased equipment and monitor maintenance and service agreements. Example: DI water system.
- Maintains the lab and its equipment in good working order, clean and organized.
- Ensure the laboratory, and all staff performing work in both labs, follows lab safety, biohazard safety practices and any other applicable regulatory requirement(s). Provide ongoing/annual training to applicable staff as needed.
- Provide assistance and backup support to laboratory operations.
QUALIFICATIONS
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
EDUCATION and/or EXPERIENCE
- Bachelor's degree in Biochemistry, Chemistry, Biology, Medical Technology, or related scientific discipline.
- 3-5 years of laboratory experience in a regulated environment.
- Previous supervisory or team leadership experience preferred.
- Strong understanding of laboratory techniques, analytical testing methods, reagent preparation, calibration processes, and validation protocols.
- Experience with FDA-regulated environments, ISO 13485 quality systems, CAP proficiency testing, and GMP/GDP documentation practices preferred.
- Proficiency with Microsoft Office 365, ERP/MRP systems, inventory management software, and laboratory documentation systems.
LANGUAGE SKILLS
Must be able to read and understand verbal and written work orders and instruction in English. Bilingual Spanish preferred but not required.
REASONING ABILITY
- Apply common sense understanding to carry out written or oral instructions;
- Must have an aptitude for mathematics and science;
- Ability to analyze technical problems and find solutions.
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.
- Must be able to sit, stand and/or move while performing job duties
- The employee must regularly lift and/or move up to 15 pounds, occasionally lift and/or move up to 25 pounds
- Visual acuity requirements including color, depth perception, and field of vision. The worker is required to have close visual acuity to perform an activity such as preparing and analyzing data and figures; transcribing; viewing a computer terminal; extensive reading
- Must have dexterity of hands and fingers to operate equipment; hearing and speaking ability to exchange information in person or on the telephone; sight ability to read schematics and information
- Ability to wear required PPE.
- Ability to work with laboratory chemicals and biological materials safely.
- Ability to stand for extended periods while performing laboratory functions.
Awareness Technology, Inc. is a Drug Free Workplace and an Equal Opportunity Employer and does not discriminate on the basis of race, ancestry, color, religion, sex, age, marital status, sexual orientation, national origin, medical condition, disability, veteran status, gender identity, or any other basis protected by law.
TO APPLY FOR THIS POSITION, PLEASE GO TO:
http://www.awaretech.com/
Awareness Technology, Inc. has been manufacturing high quality diagnostic instruments and equipment for the low to medium volume laboratory since 1982. We specialize in ELISA, chemiluminescence, Biochemistry instrumentation and ELISA reagents, with an emphasis on quality, reliability, economic design and price. Our clients have come to expect and appreciate the high level of customer service they receive from our sales and technical support staff. Awareness Technology values our business partners, and we have an earned reputation as a reliable and economic source for the equipment, supplies and advice that they depend on to service their customers.
Our Vision and Mission Statement
Our vision is to become the first name in small instrumentation design. We will offer impeccable quality, creative, exciting and effective products, with obvious value. We will be known worldwide for our ability to readily resolve seemingly complex requirements with quick, simple and affordable instrument solutions.
We will not seek to merely satisfy our corporate clients but instead, we will dazzle them with such knowledge, organization, individual attention, flexibility, courtesy and professionalism that their referrals will become our primary source of new business.
We will endorse the practice of continuous improvement, promote our interests aggressively, support free enterprise, play fair and earn a profit. We will reinvest profits for the further attainment of our corporate mission. Our employees will be smart, loyal and dependable. We will honor our company and ourselves by all we do.
Quality Policy
“In concert with our mission of continual improvement and maintaining the effectiveness of the quality management system, quality remains defined by our customers’ decisions. As long as Awareness Technology, Inc. continues to adhere to its commitment to comply with all legal and regulatory requirements and is comfortable with the ethical and liability issues, quality is what our customer says it is”.
Job Type: Full-time
Pay: From $24.00 per hour
Benefits:
- 401(k)
- 401(k) matching
- Dental insurance
- Employee assistance program
- Health insurance
- Life insurance
- Paid time off
- Vision insurance
Work Location: In person
