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GENERAL DESCRIPTION
The Quality Operations Inspector is responsible for providing support to the Company's Quality Operations to ensure that the work perform meets cGMP, and FDA regulatory compliance requirements. This individual is responsible for monitoring quality-oriented operations, such as non-conforming material control, final inspection of product, in-process inspection, line clearance, machines calibration system etc.
ESSENTIAL JOB DUTIES/RESPONSIBILITIES
To perform this job successfully, an individual must be able to perform each essential duty satisfactory. Reasonable accommodation may be made to enable qualified individuals with disabilities to perform the essential job functions. Essential job functions and duties include, but are not limited, to:
- Ensure all SOP's and GMP requirements are followed in production departments; checking the production equipment and other machines to ensure the cleanliness according to SOP and cGMP standards
- Ensure that employees are properly documenting information on the batch records (quantity, calculations, employee signatures/initials, date, etc.) at the time the activity is performed
- Verify that products, materials and components are properly and accurately labeled and correspond with the batch record present on the line
- Verify that the line is set up according to the specifications on the batch records
- Perform line in-process checks to ensure that the product quality and are produced according to specifications
- Confirm the performed line clearance at start-up of the manufacturing and packaging processes
- Verify product quantities based on batch reconciliation, and perform physical release of finished products for packaging and/or shipping
- Monitor the inventory of supplies, such as chart records, release labels, etc. and notifying Supervisor if more is required
- Participate in process improvement initiatives to reduce non-conforming products
- Conduct routine inspection of in-process product checks to meet product quality.
- Perform Internal Quality Audits with Operations and provide support to management
- Issue non-conforming reports
- Manage product retains
- Promptly report to Supervisor any situations in the production process that may impose quality and safety risk to the products and/or materials
- Coordinate with manufacturing to resolve quality issues and drive quality improvement throughout the facility
- Handle administrative duties related to the job, including SOP review and revision, documentation and record-keeping
- Follow company SOP's, cGMP regulations, and batch record instructions
- Comply with all company policies and procedures, including safety rules and regulations
- Safely perform assigned tasks and maintain a safe work environment
- Perform other duties related to the job, as assigned by management
QUALIFICATIONS
The requirements listed below are representative of the knowledge, skills, education, and/or abilities required for the job:
- Proficient knowledge and understanding of current good Manufacturing Practices (GMP), Standard Operating Procedures (SOP) and FDA regulatory compliance requirements
- Proficient skills in reading, writing, and speaking in English; bilingual (English/Spanish) skills a plus
- Proficient PC skills (Microsoft Word, Excel, in-house applications and programs)
- Proficient mathematical aptitude (addition, subtraction, multiplication, and division in units of measure, using whole numbers, common fractions and decimals)
- Effective and efficient problem-solving skills
- Attention to detail
- Strong organizational skills; able to prioritize to maximize efficiency
- Ability to work independently and in a team environment
- Effectively present information in one-on-one or group settings
- Ability to maintain a positive, professional, cooperative demeanor, conduct, and working relationship with peers, management, employees, and other individuals that interact with this position
- Ability to comply with Company policies, procedures, work rules, and protocols
- Ability to adapt effectively to workplace changes and new job duties/responsibilities
- Ability to represent the Company in a positive and professional manner at all times
The appropriate knowledge, skills and abilities required for this position are achievable through the following combination of education, work experience and training:
- High School Diploma or equivalent GED Certificate; and
- 1-2 years of work experience in a fast-paced work environment; or
- Any combination of experience, education, and training that provides the level of knowledge, skills, and experience needed to successful perform the job
PHYSICAL DEMANDS & WORKING CONDITIONS
The essential functions of this job require the employee to perform the following physical activities during the course of work:
- Communicates orally with management, employees, co-workers, vendors, suppliers, governmental compliance agencies, and the general public by telephone or in person, in one-on-one or group settings
- Regularly uses a telephone, computer (e-mail) and fax for communication
- Required to stand, walk, and sit for extended periods of time during the course of work shift
- Routinely required to stoop, bend, kneel, lift, and reach, in the performance of job function pull, push and tilt object in the performance of job function.
- Requires the essential use of hands, speech, eyesight, and hearing
- Requires agility to operate multiple telephone lines with the use of hands and head-set
- Lifting limitations for this position: 25-30 lbs
- Vision requirements include close and distance vision, color vision, peripheral and depth vision, and the ability to adjust focus as needed
- Requires incumbent to sit and operate computer for extended periods of time during course of work day, and the ability to proficiently use the computer key-board for typing
- Noise level for this work environment is typically low to moderate.Some work areas require hearing protection for an 8-hour work day.
- Periods of odoriferous environment.
- Work may involve moderate exposure to unusual elements, such as extreme temperatures, dirt, dust, fumes, unpleasant odors, and/or loud noises. Personal Protective Equipment provided as necessary.
- Work environment may involve exposure to chemicals, solutions, detergents, or solvents that require following extensive safety precautions and may include the use of personal protective equipment.
- Work environment may involve exposure to allergens such as Soy, Wheat, Fish, Shell Fish, Milk, Egg, Tree nuts, and Sesame.
Note: The Company reserves the right to modify, update, change and/or make corrections to this job description, at the sole discretion of senior management, at any time during the employee's employment term, at the sole discretion of management.
Best Formulations is an equal opportunity employer committed to employing a diverse workforce and providing accommodations for people with disabilities in all parts of the hiring process as required under its Employment Accommodation Policy. Best Formulations will work with applicants to meet accommodation needs that are made known to Best Formulations in advance.
