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Quality Assurance Technician I
2 months ago
Immediate Opportunities Available
Work Schedule: Full-time position.
Attractive Compensation & Benefits: Overtime pay, health insurance, dental coverage, vision plans, paid time off, and a 401k plan with additional benefits.
KEY RESPONSIBILITIES:
Quality & Safety are Core Values at Comar
- Conduct initial and daily visual and dimensional assessments of finished products at specified intervals according to inspection protocols.
- Execute first article inspections and evaluations.
- Perform audits of documentation, materials, finished products, and control plans at designated intervals as outlined in inspection protocols.
- Manage Non-Conforming Products - Inspect non-conforming items, initiate containment actions, and document results in accordance with established procedures.
- Collaborate with team members to ensure daily tasks are completed efficiently.
- Report issues to the Lead Quality Inspector as necessary.
- Effectively operate required equipment.
- Maintain a clean and safe working environment.
- Adhere to and communicate all plant Health, Safety, and Quality guidelines and Good Manufacturing Practices (GMP).
- Additional responsibilities for ISO13485 compliance: Provide operational support and guidance on the floor regarding ISO 13485 and cGMP standards.
- Perform other assigned duties as needed.
- Possess a fundamental understanding of cGMPs and Good Hygiene Practices.
- Inform the SQF Practitioner and/or Supervisor of any necessary repairs or adjustments.
- Carry out basic sanitation tasks.
- Fulfill all duties required to meet Company and Regulatory standards as prioritized by the Company, HACCP, and SQF.
- Notify the SQF Practitioner/Quality Manager or other management personnel of any Food Safety or Quality concerns.
- Identify issues related to Food Safety and Quality of raw materials, processes, quality systems, or safety systems through assigned Production/Quality Checks.
- Take proactive measures to prevent nonconformities related to Food Safety and Quality of products, processes, quality systems, or safety systems, and execute the HOLD Standard Operating Procedure (SOP).
- Control the further processing or delivery of nonconforming products concerning Food Safety and Quality until deficiencies are resolved.
- Adhere to all Food Fraud/Food Defense Policies while on company premises.
- Thoroughly understand all Company policies, including GMPs and safety protocols, HACCP, and SQF.
- Follow safety protocols diligently.
- Keep a clean and safe workspace and report any unsafe conditions to a supervisor.
- Utilize company-issued personal protective equipment (PPE) such as uniforms, gloves, and hairnets.
Are You?
- A high school or vocational school graduate with 0-1 years of experience in Quality Control or a GMP Manufacturing setting.
- Proficient in using computers and software applications.
- Knowledgeable in Statistical Process Control (SPC) tools and techniques, including Repeatability and Reproducibility (Gauge R&R).
- Bachelor's degree in a relevant field such as science, technology, or engineering, or significant applicable experience, training, and certifications.
- Experience in medical device, pharmaceutical, or food manufacturing sectors.
- Familiarity with visual inspection standards and processes.
- Experience in an ISO, cleanroom, or regulated environment.
- Possess the ability to read and interpret safety rules, operating instructions, and procedure manuals.
- Work effectively both independently and as part of a team.
- Demonstrate proficiency in using equipment for dimensional analysis.
- Exhibit attention to detail and the capability to identify nonconformances in documentation and materials.
- Apply basic math skills: addition, subtraction, multiplication, division, and compute rates, ratios, and percentages.
- Follow instructions provided in written, oral, or visual formats.
- Communicate job-related functions effectively with colleagues, cross-departmental teams, customers, and auditors as needed.
- Prepare routine reports as required.
- Engage with manufacturing associates to foster collaboration and trust.
- Communicate effectively with supervisors.
- Read, write, and comprehend information accurately.
- Stand for the majority of the work shift.
- Utilize hands and fingers for handling or feeling; reach with hands and arms; stoop, crouch, bend, twist, and occasionally sit.
- Lift and/or move up to 10 pounds, with heavier items moved using equipment assistance.
