Schedule- Two open Positions: Please send a message indicating the shift you are applying for

• 1st Shift Mon-Fri 8am-5pm (2 openings)
• 2nd shift Mon- Thurs ( 4x10 hours) 130pm-12:00am (1 opening)

******MUST have experience or regulatory background in FDA Part 210, 211, and 226

SUMMARY OF POSITION:

The Quality Assurance document specialist will author, format, track, store, review, update and maintain control over Quality Assurance documentation. These documents include SOPs, forms, logs, org charts, training records, supplier qualification documentation, facility-wide signage, Quality manual, sanitation records, etc. The Quality Assurance Document Specialist reports to the Director of Quality Assurance. This individual functions as an information source to production technicians and various company departments when special and critical quality issues occur.

KEY DUTIES AND RESPONSIBILITIES:

• Maintain raw materials/components database
• Maintain files and retrieve requested documents during inspections, audits, traceability exercises, recalls, market withdrawals, business continuity, etc.
• Write & revise IQ/OQ/PQ protocol documentation
• Assist in researching customer complaints; write deviation reports
• Assist with the drafting of product, ingredient and component specifications
• Assist with the review of master batch records and completed batch records
• Assist with maintaining and processing supplier qualification documentation
• Document, store, and retrieve raw material qualification
• Assist in Quality audits as needed
• Follow regulatory and cGMP guidelines at all times
• Confirm that plant audit procedures are properly carried out.
• Conduct system line clearance as needed.
• Assist in resolution of major quality problems at production facilities and warehouses.
• Educate and instruct plant personnel in recommended quality control testing, equipment sanitation and general sanitation and housekeeping practices. Confirm these procedures are being maintained.
• Maintain training records and ensure production technicians are trained on current SOPs and product specs.
• Revise product specifications as needed.
• Assist the PCQI individual in the implementation and maintenance of the FSMA initiative.
• Consult with plant management and personnel on better operational procedures to improve overall efficiency and product yields.
• Function as an information source for production technicians and other departments when quality issues arise.
• Work in conjunction with Director of Quality Assurance to assist in development of special department projects.
• Other duties as assigned

The above statements are intended to describe the general nature and level of work being performed by employees in this position. This is not intended to be an exhaustive list of all responsibilities.

EXPERIENCE REQUIRED:

2-4 years of experience in field, laboratory, or production facility.

Forklift certification a plus

EDUCATION/LICENSES/CERTIFICATION/FORMAL TRAINING:

· B.S. Chemistry, Biology, Microbiology or related field

· Professional certification in Quality, compliance or regulatory affairs a plus

ESSENTIAL ABILITIES:

• How to handle customer complaints in a professional manner
• Deviations
• Creating batch records
• Regulation: 21 CFR Part 507, 21 CFR PART 225, 21 CFR PART 226
• Excellent math and English skills
• Performance Management
• Technical Capacity
• Discretion
• Problem Solving/Analysis
• Decision Making
• Communication Proficiency
• Collaboration Skills

SUPERVISORY RESPONSIBILITY

This position has no direct supervisory responsibilities but does serve as a coach and mentor for other positions in the department.

PHYSICAL REQUIREMENTS:

· Prolonged sitting and standing.

· Ability to lift 50-75 lbs

Please be aware that our entire production facility may contain or you may come into contact with common allergens, such as dairy, eggs, wheat, soybeans, tree nuts, peanuts, fish, shellfish or wheat.

Precision Science is An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, genetic information or protected veteran status.