SUMMARY Inspect, sample and test to ensure that quality standards for production are being met to Customer and/or Bright Innovation Labs specifications using GMP's. Maintain quality standards by adhering and upholding programs to safeguard product safety and quality.
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.
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Ensure Fill and Assembly specifications are followed during production operations.
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Monitor and record weights with tarred containers using full head inspection, data collectors, or X-R control charts.
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Perform and record torques, pump to prime, and other required tests with applicable gauged and instruments.
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Conduct line clearance prior to start and at the end of production operations.
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Inspect components staged at production line and compare to specifications for correctness.
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Conduct visual inspections as required during production operations
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Verify that the correct labels, UPC's and batch codes are in use.
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Inspect for legible and correct codes on container and shippers and record.
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Call for corrective action/unacceptable quality by informing Production Supervisor, Line Lead, QA Department Lead and Mechanic. Keep Quality Assurance Supervisor/Manager advised at all times.
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Ensure production documentation is completed in compliance with Bright Innovation Labs GMP requirements.
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Follow procedure for unacceptable products by using quarantine and hold tags. Keep Production Supervisor, Line Lead, QA Department Lead and Mechanic advised on actions taken.
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Inspect finished good pallets and compare to specifications for correctness.
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Pull finished goods samples as required by Bright Innovation Labs and/or customer protocols.
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Prepare all required paperwork.
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Promote compliance with Bright Innovation Labs 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
SUPERVISORY RESPONSIBILITIES None.
EDUCATION and/or EXPERIENCE
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High school diploma or general education degree (GED). Previous working experience in similar QA positions required.
SKILLS/QUALIFICATIONS: 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.
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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.
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Experience using Microsoft Work, Excel, and Outlook
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Ability to multi-task
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Flexibility with schedule including shift work.
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Overtime may be required with very little notice
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Requires knowledge with basic math skills
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Must successfully pass a background check and drug screen
LANGUAGE SKILLS
Ability to read and comprehend simple instructions, short correspondence, and memos. Ability to write simple correspondence. Ability to effectively present information in one-on-one and small group situations to customers, clients, and other employees of the organization. Bilingual a plus.
MATHEMATICAL SKILLS
Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers common fractions, and decimals. Ability to compute rate, ratio, and percent and to draw and interpret bar graphs.
REASONING ABILITY
Ability to apply common sense understanding to carry out instructions furnished in written, oral or diagram form. Ability to deal with problems involving several concrete variables in standardized situations.
CERTIFICATES, LICENSES, REGISTRATIONS
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.
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.
