Position Details:

Industry: Medical Device / Infectious Disease Diagnostics (Regulated Manufacturing – Quality Control Laboratory)
Job Title: Quality Control Technician I
Duration: 12 Months  Contract
Location: South Portland, ME 04106 (100% Onsite)
Shift Details: Monday – Friday | 2:00 PM – 10:30 PM (2nd Shift) | 8 Hours/Day | 40 Hours/Week
Note:: Will train on 1st shift before moving to 2nd shift
Pay Range: $20.00 - $26.00 per hour 

Position Summary

• This position of Quality Control Technician I is located at South Portland, Maine. In this role you will perform work required to ensure Company product quality is maintained at standards set forth by Company Quality System and mandated by regulatory agencies such as the FDA, ISO, and CMDR.
• Perform a wide variety of activities to support the Quality Management System.

Key Responsibilities

• Perform testing of in-process components for Lateral Flow, ELISA and Molecular products.
• Perform final release testing for Lateral Flow, ELISA and Molecular products.
• Troubleshooting of technical and quality issues.
• Undertake new procedures and observe proper safety precautions.
• Able to perform technical procedures and use laboratory equipment.
• Review batch records.
• Calibrate/maintain laboratory equipment.
• Maintain Good Manufacturing/Laboratory Practices (GMP/GLP).
• Perform a wide variety of activities to support the Quality Management System.
• Follow procedures and accurately document results.
• Understand the manufacturing processes of Company products and recognize deviations from approved documented procedures.
• Ability to use bleach for cleaning purposes is required.

Education & Experience

• Associates degree in Biology, Chemistry, Life Sciences or other related technical field or equivalent combination of education and experience.
• 1+ years of laboratory and/or quality control experience.
• Preferred Qualifications:
• 2+ years’ experience in a regulated industry.
• 2+ years’ experience with GMP, FDA, ISO and USDA regulations.
• Prior experience in:
• Pipette experience
• pH meter
• ELISA assays

Additional Education Criteria:

• Bachelor's degree in a scientific or technical area or equivalent combination of experience and education.
• At least one year in quality assurance role in medical device industry is preferred.

Technical / Business Knowledge (Job Skills)

• Working knowledge of internet software, MRP Inventory/Manufacturing software and MS Office Suite (Outlook, Excel, and Word).
• Knowledge of enzyme and/or immunochromatographic assays.
• Knowledge of inspection/measurement systems.
• Systematic troubleshooting skills.
• Statistics and data analysis knowledge.
• Ability to follow Good Manufacturing/Laboratory Practices (GMP and GLP).
• Ability to read and interpret safety rules, operating and maintenance instructions, and procedure manuals.
• Ability to write routine reports and correspondence.
• Ability to speak effectively before small groups of customers or employees of organization.
• Ability to apply mathematical concepts such as fractions, percentages, ratios, and proportions to practical situations.
• Knowledge of database software, internet software, inventory software, spreadsheet software, and word processing software.

Cognitive Skills

• Ability to perform each essential duty satisfactorily.
• Ability to follow procedures and accurately document results.
• Attention to detail.
• Ability to recognize deviations from approved documented procedures.
• Exercises judgment within defined procedures and practices.

Physical Demands

• While performing the duties of this Job, the employee is regularly required to sit and stand. The employee is occasionally required to walk.

Work Environment

• The noise level in the work environment is quiet to moderate.
• Work is performed in a regulated manufacturing and laboratory environment.

Benefits:
The Company offers the following benefits for this position, subject to applicable eligibility requirements: medical insurance, dental insurance, vision insurance, 401(k) retirement plan, life insurance, long-term disability insurance, short-term disability insurance, paid parking/public transportation, (paid time , paid sick and safe time , hours of paid vacation time, weeks of paid parental leave, paid holidays annually – These all are subject to applicable eligibility).