Metrology and Validation Supervisor

Job Description

SUMMARY

Under limited supervision, the Metrology and Validation Supervisor is responsible for supervision of all metrology/validation personnel, executing the activities required to comply with appropriate equipment, cleaning, water system validation and other support systems to ensure that product is manufactured in accordance with appropriate regulatory agency validation requirements, company standard operating procedures (SOPs), and current Good Manufacturing Processes (cGMP). The Metrology/ Validation Supervisor is responsible for calibrating, monitoring/verifying and coordinating calibration of the facility’s measurement instruments. The Metrology/Validation Supervisor is also responsible for conducting equipment and cleaning validation studies including writing protocols, coordinating with other departments, and data analysis. Must readily adapt to manufacturing, laboratory and warehouse conditions.

ESSENTIAL RESPONSIBILITIES

Maintains the calibration schedules for all existing and new equipment

Performs in-house calibration

Monitors employee performance and ensures all staff members perform job functions in accordance with SOPs, cGMPs, quality and safety requirements and adhere to company and regulatory agency policies and procedures.

Assists with scheduling outside calibration services

Verifies all calibration performed by outside services for accuracy and audits certificates prior to filing.

Maintains all the calibration files and certificate of calibration

Updates Calibration Program of company’s equipment to ensure conformance and compliance.

Maintains, repairs and troubleshoots instrumentation issues included in the calibration program and ensures conformance to established calibration standards

Prepares and executes equipment/instrument Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ) protocols and reports

Prepares and executes cleaning validation protocols and reports

Conducts general and job-specific training for all employees

Evaluates cleaning validation data and makes recommendations for changes and/or improvements

Conducts equipment/instrumentation failure investigations and troubleshoots problems

Consistently demonstrates excellent interpersonal skills and professionalism to company management, all levels of staff, vendors and outside agencies.

Adheres to company policies and procedures and sets a positive example for others within the organization.

SUPERVISORY RESPONSIBILITIES This position has direct supervisory responsibilities for the Metrology/Cleaning Validation department and is responsible for interviewing, selecting, training, coaching and developing employees, addresses performance deficiencies, conducts formal and informal performance evaluations, recommends personnel actions such as position upgrades, salary adjustments, promotions, and terminations. Addresses interpersonal conflicts, manages work schedule and assignments within the departments.

QUALIFICATIONS To perform this job successfully, an individual must be able to perform each essential responsibility satisfactorily using the skills and abilities outlined in this job description. The requirements listed below are representative of the knowledge, skills and/or abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Must be able to read, understand and interpret Material Data Safety Sheets (MSDS) and follow Standard Operating Procedures, and OHSA guidelines.

Discretion in handling confidential and sensitive matters.

Capable of handling fast paced production environment.

EDUCATION, EXPERIENCE AND LICENSURE

Experience with aseptic technique for water sampling, Bio-Luminator, and wet swab testing

Experience in writing/revising SOPs and Validation protocols

Proficient in chemistry and biology as used in pharmaceutical manufacturing testing and validation process

College degree in chemistry, biology or related scientific field or 3 to 5 years relevant experience

Prior experience in cGMP manufacturing environment

Prior supervisory experience a plus

Knowledge and expertise of calibration practices and NIST procedures

TECHNICAL SKILLS

Proficient use of Microsoft Office products including Word, Excel, and Outlook

Good oral and written communication.

Ability to quickly learn new instrument, equipment and software programs as needed

LANGUAGE SKILLS Must have the ability to communicate in English including proficiency in reading, writing and speaking.

MATHEMATICAL SKILLS Analyze and present quantitative data; compute mathematical equations such as addition, subtraction, division, multiplication, percentages, and statistics.

REASONING ABILITY Analyze and interpret data relating to various projects and resolve issues and problems that arise. The Metrology/Cleaning Validation Supervisor must be able to:

Resolve issues of a general, routine or complex nature, exercise sound judgment and escalate issues and problems that arise.

Provide troubleshooting ideas for issues that may arise. Suggest preventative and routine maintenance to reduce equipment/instrument failures.

Prioritize routine work assignments and special projects to ensure goals and timelines are met.

PHYSICAL DEMANDS AND WORK ENVIRONMENT The physical demands and work environment described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential job functions.

Work will be conducted in a standard office and manufacturing environment with associated distractions such as noise from telephones, keyboards, talking, paging systems, machinery and equipment. Temperatures are regulated by facilities management and are not within the direct control of the individual. Temperatures in the warehouse and production areas may be extremely hot or cold and not within the control of the individual.

Work is done while sitting down, using a computer keyboard and gazing at a computer monitor; walking throughout the facilities including the warehouse and production areas.

Position requires the incumbent to move from the office work area to other areas of the company, including other offices, cubicles, warehouse and production areas, conference rooms and other offices in the same building or another building. The incumbent may be required to walk or drive his or her own vehicle to a second location a short distance away.

Must be able to sit for up to six hours per day, stand or walk for up to eight hours per day; climb up and down ladders without assistance; lift and carry up to 20 lbs with or without assistance, reach above shoulder height or below knees, bend, stoop, kneel and crawl to retrieve or inspect items at ground or floor level; open and close cabinets or drawers; push and pull, use a computer keyboard throughout the workday, stand while filing or performing other essential responsibilities.

Exposure to standard chemicals used in an office environment is expected and includes but is not limited to toner, glue and liquid paper or white out. Additionally, the incumbent may be exposed to chemicals used in the manufacturing process of nutritional supplements, cosmetics, and prescription drugs.

Must have reliable transportation and valid driver’s license and be able to drive to appointments. Must maintain current, in-force vehicle insurance.

Full-time