Job Description

• OBJECTIVE

This role supervises the QC lab and QA teams and provides technical support for production by means of chemical and physical analysis of production concentrates and finished products. Maintain quality standards by adhering and upholding programs to safeguard product safety and quality.

• ESSENTIAL FUNCTIONS: include the following. Other duties may be assigned.
• Supervise and direct all routine Quality Control Lab and Quality Assurance functions and staff.
• Responsible for all phases of physical and chemical evaluation and analysis of materials, packaging and goods produced
• Evaluate staffing requirements, levels and performance; recommend actions as appropriate
• Interface with all other departments in routine technical matters
• Statistical evaluation of quantitative data for executive management
• Collect and present analytical data generated by the Quality Control Team for both internal projects and externally where required. Support the Quality team during regulatory audits, including presenting information and supporting laboratory tours
• Develop quality control plans by identifying critical control points and preventive measures; establishing critical limits, monitoring procedures, corrective actions, and verification procedures; monitoring inventories
• Validate quality processes by working with Production and other departments to establish components and assembly specifications and quality attributes and updating quality assurance procedures
• Maintains and improves component and assembly quality by completing audits, investigating internal and external customer complaints, working with other members of management to develop product and engineering design improvements and manufacturing and inspection methods
• Prepares quality documentation and reports by collecting, analyzing and summarizing information and trends including failed processes, stability studies, parts rejects, corrective actions and re-validations
• Assist in development of departmental budget; monitor purchases and expenses on routine basis
• Completes special projects as deemed necessary
• Responsible for providing monthly safety/CGMP training for department and oversee general training & training documentation for personnel
• Oversee the cleanliness of the Quality Control laboratory areas as needed to maintain a safe and clean working environment
• Oversee staff chemists in troubleshooting analytical methods, instrumentation problems, and production issues
• Understand, exercise, and enforce all cGMP and safety requirements and procedures
• Promote compliance with BIL policies, procedures, quality standards and current Good Manufacturing Practices (cGMP) as well as safety and environmental regulations. Participate, as required, in safety and GMP training sessions, and other company training sessions

• COMPETENCIES

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below 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.

• Must have strong verbal and writing skills along with strong communication skills. Must be able to speak, read, and write in English, Spanish a plus.
• Experience using Microsoft Word, Excel, and Outlook
• Ability to multi-task
• Flexibility with schedule including shift work.
• Requires knowledge with basic math skills.
• Must successfully pass a background check and drug screen
• Strong managerial and leadership skills
• Ability to use laboratory equipment such as a microscope, incubators, autoclaves, hot plates, laboratory glassware, pipettes, etc.
• Strong knowledge in laboratory safety
• Flexibility with schedule including shift work
• Overtime may be required with very little notice

• SUPERVISORY RESPONSIBILITIES
  • Directly supervises a staff of chemists, Microbiologists, and incoming Raw Materials team, responsibilities include training employees and directing work.

• WORK ENVIRONMENT
• The work environment characteristics described here are representative of those an employee encounters while performing 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 exposed to moving mechanical parts. The employee is occasionally exposed to fumes or airborne particles. The noise level in the work environment is usually moderate.
• 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 regularly required to stand; use hands to finger, handle, or feel; reach with hands and arms; and talk or hear. The employee frequently is required to walk; and stoop, kneel, crouch, or crawl. The employee is occasionally required to sit, and taste or smell. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, color vision, depth perception, and ability to adjust focus.
• POSITION TYPE/EXPECTED HOURS OF WORK

• This is a full-time position. The base days and hours are Monday through Friday, eight (8) hours per day depending on shift assigned.
• Overtime may be required with very little notice.

• TRAVEL
  • No travel is expected for this position.

• REQUIRED EDUCATION & EXPERIENCE
• Bachelor's degree in chemistry or other related science or equivalent relevant experience. Five to six years of previous Quality Control experience. Minimum of two years previous Laboratory Supervision/Management experience.
• PREFERRED EDUCATION & EXPERIENCE LANGUAGE SKILLS
• N/A
• LANGUAGE SKILLS: Must have excellent strong verbal and writing skills along with strong communication skills. Must be able to speak, read, and write in English. Ability to read, analyze, and interpret common scientific and technical manuals and instructions, professional journals, technical procedures, or governmental regulations. Ability to write basic reports and assist in editing procedure manuals. Ability to effectively present information and respond to questions from laboratory staff and quality personnel
• MATHEMATICAL SKILLS: Ability to apply mathematical concepts such as exponent, logarithms, quadratic equations, and permutations. Ability to apply mathematical operations to such tasks as frequency distribution, determination of test reliability and validity, analysis of variance, correlation techniques, sampling theory, and factor analysis
• 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 and deals with several abstract and concrete variables

• ADDITIONAL ELIGIBILITY QUALIFICATIONS
  • English language and knowledge of the structure and content of the English language including the meaning and spelling of words, rules of composition, and grammar.

• WORK AUTHORIZATION
  • Must be authorized to work in the U.S. as a pre-condition of employment.

• EEO STATEMENT
  • Bright Innovation Labs is an equal opportunity employer. Bright Innovation Labs does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need.

• OTHER DUTIES

Subject to change.