Laboratory Support Specialist, Training (GA)

Job Title: Laboratory Support Specialist, Training (GA) Revision: 0000 Job Code: 702638 Shift: Primarily day shift, 7:00 a.m. - 5:30 p.m. Sun-Wed, Mon-Th, Tues-Fri shift options, must be able to train overnight FLSA: OT Eligible Hybrid? N Dept.: Lab Support GA Business Unit: QualTex‐GA CPF Level: P3

General Summary Responsible for the development of content in internally facing documents, such as SOPs, Work Instructions, Job‐ Aids, Training Documents, Forms, and assay/equipment validation plans. Commit to and abide by the character of BioBridge Global’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 (internal or external, including donors for select positions) through multiple feedback channels in order to resolve issues and drive satisfaction in accordance with the BBG customer engagement, feedback, and complaint processes.

Major Duties and Responsibilities

Essential Tasks

Competently perform all assigned departmental duties.

May include specialized support in the Training area that includes:

• Perform training objectives, curriculum, strategies, policies, and programs.
• Provide hands‐on training for QualTex Laboratories employees.
• Attend advanced vendor training to assist in development of on‐site training program.
• Evaluate and monitor the training program for effectiveness, regulatory compliance, and timeliness of completion.
• Maintain training documentation in accordance with regulatory requirements.
• Evaluate reports in an accurate and timely manner; recognize and resolve unusual problems.

Assist in developing, planning, and conducting training enhancements. Operate equipment utilizing established protocols and within quality control limits.

Maintain strict adherence to Standard Operating Procedures (SOPs).Prepare and maintain correspondence, reports, and records as needed.

Perform computer data entry. Commit to and embrace the mission, vision, and core values of QualTex Laboratories:

• Positive work attitude
• Respect for co‐workers and management staff
• Excellent customer service [for both internal and external customers]
• Adherence to all safety, regulatory, and quality requirements
• Continuous improvement

Participate in continuing education and attend meetings as required. Participate in team‐oriented work projects for the development and implementation of validations, process improvements, and Standard Operating Procedures (SOPs). Work closely with the laboratory services and laboratory support staff.

Performs other duties as assigned.

Education Requires a Bachelor’s Degree from an accredited college or university with major course work relative to the field of assignment.

Licenses and/or Certifications Certified Medical Laboratory Technician/Scientist, (MLT/MLS), (ASCP) preferred

Experience Requires three years of laboratory experience (testing samples).

Requires one or more years of training experience. Requires one year of related experience in a FDA regulated setting for drug, device, or biologic product development/manufacturing. Prefer one or more years of technical writing and communications experience.

Prefer experience in adult education or a previous dedicated training role.

Knowledge Must obtain a working knowledge of regulatory/quality requirements and perform within all Standard Operating Procedures (SOPs) and policies. Must acquire a working knowledge of establishing standard documentation practices, templates, and style guidelines. Must acquire an understanding in document control, product change control, quality systems, and regulatory documentation.

Skills Must produce documents with clarity, flow, organization, completeness, accuracy, readability, and appropriateness. Must contribute in determining optimal presentation of technical data.

Must have experience using Adobe Suite programs. Must have strong computer skills. Must have experience using Microsoft Office applications including Word, Outlook, Visio, PowerPoint and Excel. Must have excellent written and oral communication skills. Must be able to print and write legibly.

Abilities Must be a self‐starter and self‐directed worker. Must be able to anticipate customer and stakeholder requirements.

Must be able to keep information confidential. Must be able to perform multiple requests simultaneously while maintaining quality and accuracy.

Must be able to quickly learn new software or database systems. 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.

Working Environment Works in a well‐lighted air conditioned and heated laboratory/department.

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. 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 manual and finger dexterity and eye‐hand coordination.

Required to lift and carry relatively light materials.