Job Description

1. SUMMARY / OBJECTIVE

To control and assure and provide technical support for production by means of basic microbiological analyses of finished products, raw materials, and water. To sample and test raw materials for microbial contamination. Maintain quality standards by adhering and upholding programs to safeguard product safety and quality.

1. ESSENTIAL FUNCTIONS: include the following. Other duties may be assigned.

• Comply with Bright Innovation Laboratories' policies, SOP's, quality standards and current Good Manufacturing Practices (cGMP) as well as safety and environmental regulations.
• Collection and sorting of received microbiological samples. Perform microbiological testing of raw materials, finished products, and water samples, using Bright Innovation labs approved methods.
• Recording samples in laboratory records and electronic tracking systems.
• Ensure accuracy of results and documentation prior to releasing products for distribution.
• Environmental monitoring activities under the guidance of the Plant Hygienist and Microbiology Lead.
• Cleaning and maintenance of microbiology laboratory utensils and equipment.
• Interface with QC, Production, Compounding and R&D as needed.
• Prepare media for pour plating by weighing, hydrating, and sterilizing media use.
• Quality testing of microbial media to verify performance against client specifications and consumer safety requirements.
• Understand and perform Gram stain and identification of contaminants through the use of API Kits.
• Investigate Out-of-Specifications (OOS) and perform root cause analyses.
• Document analytical results, utilizing approved forms and reports. Interface with QC & QA Managers in reporting inconsistencies or discrepancy of test results.
• Prepare standards, reagents, media, and equipment as directed to support laboratory operations.
• Maintain instruments, calibration of gauges, and document equipment performance as directed.
• Promote compliance with Bright Innovation Laboratories 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

1. 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.

• Ability to use Microsoft Word, Excel and Outlook
• Ability to use laboratory equipment such as a microscope, incubators, autoclaves, hot plates, laboratory glassware, pipettes, etc.
• Ability to perform work with minimal supervision and guidance
• Ability to multi-task
• Accurate and have strong attention to detail
• Flexibility with schedule including shift work

1. SUPERVISORY RESPONSIBILITIES

• This position has no supervisory responsibilities.

1. WORK ENVIRONMENT

• While performing the duties of this job, the employee may occasionally experience exposure to wet and/or humid conditions, moving mechanical parts, fumes or airborne particles, and toxic or caustic chemicals. The noise level in the work environment in these situations may be lower. Normal work environment has low levels and mild humidity.

1. 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 stand, walk, sit, use hands and fingers, talk or hear. Infrequent stair climbing. The employee is occasionally required to reach with hands and arms and to move within and between the buildings. The employee must occasionally lift and/or move up to twenty (20) pounds. Close vision is required by this job. A computer terminal is used to access, input, and retrieve data.

1. 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.
• Weekend work required.

1. TRAVEL

• No travel is expected for this position.

1. REQUIRED EDUCATION & EXPERIENCE

• High school diploma or general education degree (GED). Previous working experience in similar QA positions required.

1. PREFERRED EDUCATION & EXPERIENCE LANGUAGE SKILLS

• BS in Microbiology/Chemistry or related sciences knowledge. 2-year experience in lab setting
• Experience with gram stains, sub-culturing and identification of microorganisms and environmental monitoring
• Experience with current practices and procedures used in microbiological and analytical laboratory
• Good understanding of FDA Good Manufacturing Practices Regulations (GMP's) and OSHA safety requirements
• Self-starter with strong work ethic
• Ability to plan ahead to minimize potential issues as well as to meet company growth objectives
• Ability to perform professional, scientific laboratory work to insure conformity to company and customer requirements
• Able to work overtime & weekends as required

1. ADDITIONAL ELIGIBILITY QUALIFICATIONS

• 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.

1. WORK AUTHORIZATION

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

1. 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.

1. OTHER DUTIES

• Subject to change.