Description

Manages overall performance of the Quality Control laboratory to ensure the timely and accurate testing of materials and products while maintaining and ensuring all quality and compliance requirements are satisfied. Provide oversight and guidance on day-to-day activities of Quality Control Laboratory personnel.

ESSENTIAL FUNCTIONS, included but not limited to:

Responsible for overall management strategy for Quality Control (QC) staff.
Accountable for ensuring full quality and regulatory compliance of quality control analytical activities.
Lead, organize and maintain all department and laboratory processes, procedures, and administrative duties.
Define priorities for the QC department. Ensure alignment of QC priorities with the site priorities/strategy, also ensure strategy deployment.
Plan testing and inspection activities of the QC Laboratory to meet production schedules.
Manage and work with team to resolve QC non-conformances and other identified issues. Coordinate the sequence of issue resolution across the department to ensure minimal customer impact. Support root cause analysis and implement corrective actions.
Identify and manage business risks & opportunities in the QC department.
Foster relationships with cross functional roles on a local level.
Assure adequate communication of priorities exists between the lab and other departments and within the lab.
Function as liaison with external parties on matters relating to QC testing status, approvals, rejections, documentation status, and any other QC matters to support all internal departments and customers.
Develop and implement systems designed to support assay development, stability, raw material, and finished product testing.
Continuous management, development, and improvement of stability program.
Provide guidance to resolve problems with instruments, test methods, lab chemicals, standards, and samples.
Ensure all raw materials, bulks, and finished goods are tested in accordance with all regulatory, company, and customer requirements, as applicable.
Manage method validations/qualifications.
Identify and report non-conformances/deviations/out-of-specification events.
Investigate deviations and write exception documents as required, utilizing problem solving tools as needed.
Prepare justification for new lab equipment. Prepare purchase orders and coordinate authorization and procurement. Arrange installation and qualification.
Ensure audit readiness and ensure staff members work according to established processes to be fully compliant with current Good Manufacturing Practices (cGMP).
Adhere to current Good Manufacturing Practices (cGMP); Ensure all direct reports comply.
Comply with Company policies, Quality Management System (QMS) and Standard Operation Procedure (SOPs), etc.

OTHER FUNCTIONS:

Ensure compliance with safety regulations and procedures are followed; Maintain clean and safe work area.
Assist as needed in other areas of the company where training requirements have been completed.
Perform other duties as assigned.

SUPERVISORY RESPONSIBILITIES:

Directly manage the Quality Control personnel at the Boerne site.
Fulfill manager responsibilities in accordance with the organization's policies and applicable laws; Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.

TRAVEL

Up to 10%.

Requirements

Bachelor's degree in a life science related field.
Legally authorized to work in the United States.
Five (5) experience laboratory experience in a biology, chemistry, or medical environment.
Two (2) years supervisory or management experience.
Ability to apply scientific methods to create testing standards and troubleshoot test methods.
Experience in change management, root cause analysis, risk assessment, and out-of-specification (OS) investigations.
Strong knowledge of biological and chemical concepts.
Experience in a cGMP or regulated environment.
Working knowledge of chemistry analyzers.
Knowledge of various standards and regulations such as ISO 9001, ISO 13485, the Quality System Regulation (21 CFR Part 820).
Pipetting experience.

PREFERRED QUALIFICATIONS:

Prior manufacturing experience.
Medical Laboratory Technician (MLT) or Medical Technologist (MT) Certification.

BASIC SKILLS AND ABILITIES:

Proficient in Microsoft Outlook; Working knowledge of Microsoft Excel and Word.
Demonstrate familiarity with product specifications, process reference files, code of federal regulations, and compendia requirements.
Project a positive company image by interacting with fellow employees, customers, and management in a cooperative, supportive, and courteous manner; displays a professional attitude.
Detail oriented with a high level of accuracy, efficiency, and accountability.
Excellent organizational skills to meet goals and set priorities.
Proven ability to handle multiple projects and meet deadlines; work in a fast-paced environment.
Ability to work independently and as a member of various teams and committees.
Versatility, flexibility, and a willingness to work within constantly changing priorities with enthusiasm.
Initiative to offer new innovative ideas and improve processes.
Foster a participative management style advocating a team concept.
Good coaching, mentoring and leadership skills; able to provide constructive feedback that develops employees and their long-term contributions to EKF Diagnostics.

REASONING ABILITIES:

Ability to apply common sense understanding to carry out instructions furnished in written, oral, or diagram form.
Must have strong analytical and planning skills sufficient to determine resources and time required to complete projects.
Ability to define problems, collect data, establish facts, and draw valid conclusions.
Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.

LANGUAGE SKILLS:

Good written and oral communication skills; ability to read, write, speak, and understand the English language; ability to communicate effectively, internally, and externally at all levels.
Exceptional interpersonal and leadership skills; ability to communicate effectively, internally, and externally at all levels and diverse personalities.
Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations.
Ability to write reports, business correspondence, and procedure manuals.

MATHEMATICAL SKILLS:

Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals.
General knowledge of the metric system units (length, area, volume, capacity, mass, and weight) and U.S. equivalents.

VISUAL ACUITY:

Close visual acuity to perform an activity such as preparing and analyzing data, transcribing, viewing a computer terminal, and reading.

PHYSICAL DEMANDS:

Must be able to wear and work in personnel protective equipment (PPE) as required.
Light physical activity performing non-strenuous daily activities in a laboratory setting.
Ability to hear, understand, and distinguish speech.
Constant repetitive motions that may include the wrists, hands and/or fingers to operate keyboard and mouse; Dexterity and coordination are necessary to handle small components.
Frequently stand for prolonged periods of time.
Occasionally move about inside the facility to access office machinery, correspond with other departments, attend meetings/training, etc.
Frequently lift, carry, push, pull or otherwise move objects up to 10 pounds; occasionally carry, push, pull or otherwise move objects up to 25 pounds.
Occasionally sitting, squatting, stooping, kneeling, or crouching.
Occasionally reaching for items above and below desk level.

ENVIRONMENT CONDITIONS:

Well lit, heated/air-conditioned indoor laboratory setting with adequate ventilation.
The noise level in the work environment is moderate.
Frequent exposure to low temperatures in controlled refrigerators and/or freezers.
Occasional exposure to biohazards, fumes, and other airborne particles.