Job Title: Quality Control Lab Manager Department: Quality Reports To: Director of Quality FLSA Status: Exempt
Summary
Oversee the operational aspects of the Quality Control Department relating to the manufacture and distribution of products in strict accordance with Standard Operating Procedures, current Good Manufacturing Practices, company policies and procedures, and utilizing FDA requirements governing the manufacture of dietary supplement, personal care, and essential oil products
Essential Duties and Responsibilities
Essential duties and responsibilities include the following (other duties may be assigned):
Assign, direct, and schedule staff
Oversee performance of tests in fields of microbiology and analytical chemistry; ensure that incoming materials, in-process materials, and finished goods are tested in a timely manner; consult on work in progress and completed work to assure accuracy
Evaluate and modify department's policies and lab procedures, methods, and standards; develop and validate lab methodologies
Assist Research & Discovery and Product Development in establishing standards, normal values, and methods of control for the laboratory tests performed
Prepare or direct preparation of various qualitative and quantitative reports and records
Assist the director of quality in designing, implementing, and monitoring the quality control program for both developing new products and for controlling the quality of current products
Evaluate current product specifications and perform a comprehensive review of all products to determine testing requirements for label claims, identity, purity, strength, composition, and limits on contamination that may adulterate or that may lead to adulteration of each product
Implement and monitor the stability, shelf life, and expiration dating program; ensure written specifications for product release and product expiration dating
Make sure that the Quality Control Department meets the needs of USA 21 CFR part 111; protect the customer from potential harm by reporting all out-of-control, out-of-specification, and abnormal testing results to the director of quality
Maintain documentation and records such as results of analytical tests performed, lab investigations, CAPA’s, machine and method validations, research projects, analysis of product failure, and new product development testing
Involved in planning, administering, and adhering to the Quality Control Laboratory budget; purchase or direct purchase of laboratory equipment and supplies
Direct the proper storage of hazardous materials
Ensure employee and visitor safety by implementing, training, and following a laboratory safety program
Coordinate with outside laboratories to conduct analysis or experiments that exceed internal lab capabilities
Review current literature, attend meetings, go to training to keep informed of new developments in the fields of FDA law, dietary supplements, international standards, laboratory safety, analytical testing, and microbiological testing
Keep the director of quality informed and updated about personnel performance, testing results, testing status, testing reports, monthly progress, instrument needs, status of SOPs, travel, training, and process improvements
Education and Experience
Bachelor's degree and eight to ten years of related quality control lab management experience
Familiar with the operation of and ability to train the analytical lab technicians and scientists on various instruments such as, GC, Specific Gravity, Polarimetry, Titration, FT-IR, Flashpoint, HPLC, etc.
Extensive knowledge of all FDA regulations that include but are not limited to cGMPs; cGLPs; HAACP; food, cosmetic and international regulations; labeling regulations; and HACCP
Supervisory Responsibilities
Directly supervise both analytical and microbiological lab employees; interview, hire, and train employees; plan, assign, and direct work; appraise performance; reward and discipline employees; address complaints; resolve problems
Carry out supervisory responsibilities in accordance with the organization's policies and applicable laws
Include staff in planning, decision-making, facilitating, and process improvement
Take responsibility for subordinates' activities; be available to staff; provide regular performance feedback to subordinates; develop subordinates' skills and encourage growth; solicit and apply customer feedback (internal and external); foster quality focus in others; improve processes, products, and services; continually work to improve supervisory skills
Presentation Abilities
Must have solid presentation abilities
Must be able to prepare, organize, and present viable content to a group of people
Must have knowledge of PowerPoint, Excel, and Word or their equivalent
Competencies
To perform the job successfully, this individual should demonstrate the following competencies:
Analytical – Synthesize complex or diverse information; collect and research data; use experience to complement data; design work flows and procedures; improve processes, products, and lab services
Problem Solving – Identify and resolve problems in a timely manner; gather and analyze information skillfully; develop alternative solutions
Project Management – Develop project plans; coordinate projects; communicate changes and progress; complete projects on time and budget; manage project team activities
Technical Skills – Assess own strengths and weaknesses; pursue training and development opportunities; strive to continuously build knowledge and skills; share expertise with others
Attitude – Demonstrate a positive “can do” attitude; show motivation; must be goal oriented and a self-starter; be “solution-minded” rather than “problem-minded”
Work Ethics – Must be dedicated, responsible, hard-working, and a team player
Oral Communication – Speak clearly and persuasively in positive or negative situations; listen and get clarification; respond well to questions; demonstrate group presentation skills; participate in meetings
Written Communication – Write clearly and informatively; edit work for spelling and grammar; vary writing style to meet needs; able to read and interpret written information
Organizational Support – Follow policies and procedures; support organization's goals and values; benefit organization through outside activities
Strategic Thinking – Develop strategies to achieve organizational goals; analyze market and competition; identify external threats and opportunities; must be able to contribute to group initiatives
Quality Management – Look for ways to improve and promote quality; demonstrate accuracy and thoroughness
Diversity – Demonstrate knowledge of EEO policy; show respect and sensitivity for cultural differences; educate others on the value of diversity; promote a harassment-free environment; build a diverse workforce
Teamwork – Balance team and individual responsibilities; exhibit objectivity and openness to others' views; give and welcome feedback; contribute to building a positive team spirit; put success of team above own interests; able to build morale and group commitments to goals and objectives; support everyone's efforts to succeed
Judgment – Display willingness to make decisions; exhibit sound and accurate judgment; support and explain reasoning for decisions; include appropriate people in decision-making process; make timely decisions
Professionalism – Approach others in a tactful manner; react well under pressure; treat others with respect and consideration, regardless of their status or position; accept responsibility for own actions; follow through on commitments
Safety and Security – Observe safety and security procedures; determine appropriate action beyond guidelines; report potentially unsafe conditions; use equipment and materials properly
Adaptability – Adapt to changes in the work environment; manage competing demands; change approach or method to best fit the situation; able to deal with frequent changes, delays, or unexpected events
Attendance and Punctuality – Be consistently at work and on time; ensure work responsibilities are covered when absent; arrive at meetings and appointments on time
Dependability – Follow instructions, respond to management direction; take responsibility for own actions; keep commitments; commit to long hours of work when necessary to reach goals; complete tasks on time or notify appropriate person with an alternate plan
Innovation – Display original thinking and creativity; meet challenges with resourcefulness; develop innovative approaches and ideas
Delegation – Delegate work assignments; match the responsibility to the person; give authority to work independently; set expectations and monitor delegated activities; provide recognition for results
Cost Consciousness – Work within approved budget; develop and implement cost-saving measures; contribute to profits and revenue; conserve organizational resources
Organizational Support – Follow policies and procedures; complete administrative tasks correctly and on time; support organization's goals and values; benefit organization through outside activities; support affirmative action and respect diversity
Language Skills
Ability to read, analyze, and interpret common scientific and technical journals, professional journals, technical procedures, or governmental regulations
Ability to write reports, business correspondence, and procedures manuals
Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public
Reasoning Ability
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 to deal with several abstract and concrete variables
Computer Skills
Knowledge of Internet, spreadsheet, and word processing software
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 frequently required to sit and talk or hear.
The employee is occasionally required to stand; walk; use hands to finger, handle, or feel; and reach with hands and arms.
The employee must regularly lift and/or move up to 10 pounds and occasionally lift and/or move up to 25 pounds.
Work Environment
The noise level in the work environment is usually quiet. The individual must be able to tolerate the scent of essential oils worn or diffused.
Young Living Essential Oils is an equal opportunity employer. Young Living participates in E-Verify, a service of DHS and SSA to confirm work authorization.
