QA Lab Tech NJ

Job Summary: Provide Quality Assurance support for production, purchasing, product development, project managers, and customers. Assist various groups to interpret and ensure product regulations and customer requirements are met. Quality Technicians review test data results, CoAs, and production records for both raw material and finished product release.

Essential Accountabilities:

• Provide daily support to all manufacturing cells and other internal customers for Quality related issues and concerns.
• Maintain device history record and test data review and release of finished goods.
• Inspection and release of raw materials, raw material defects identified before being released to production
• Perform non-conforming material investigations. Write investigation reports. Update NCM raw materials and finished product disposition.
• Work on special projects as assigned by the QA Manager or QA Engineer.
• Train and develop QA technicians.
• Training and development of production floor associates in quality, procedures, and production records.
• Provide data as needed on request for Quality and Operational issues.
• Provide external customers with required finished good samples, Certificates of Analysis or Certificates of Manufacture for products produced by Rockline/Iatric.
• Conduct or participate in internal audits.
• Gather QA data and compose investigative reports.
• May write QA procedures and work instructions.
• Oversee the incoming inspection program and the skip lot program.
• May supervise QA Lab Techs.
• Demonstrate commitment to Rockline’s RRITE Values of Renew, Respect, Integrity, Teamwork, and Excellence.
• Associates have a direct and important role in ensuring that all work is performed in a safe manner. Effectiveness in carrying out this responsibility is part of each associate’s essential accountabilities.
• Contribute to a cooperative working effort by demonstrating a willingness to perform other job-related work, as needed or requested.

This position is designated as a Safety-Sensitive (A safety-sensitive position is one in which the associate’s inability or impaired ability to perform their job-related tasks could result in a direct threat to the associate’s safety or the safety of others).

Qualification Requirements:

• High School Diploma/GED, required plus 5 years’ experience in Quality, a Laboratory setting or manufacturing; associate OR bachelor’s degree in technical, quality or life science preferred, or any combination of equivalent education and experience.
• Working knowledge of Microsoft tools (Word, Excel, PowerPoint) required.
• Strong problem-solving skills.
• Ability to communicate across all levels of the organization.
• Working knowledge of the FDA’s regulations (21 CFR) is highly recommended.
• Ability to work in a fast-paced, high-pressure environment with limited supervision is a plus.
• Work prioritizing is essential for success.
• Ability to make sound decisions and influence others.
• Experience in conducting audits highly desired in addition to demonstrated leadership skills.

Physical and Mental Requirements:

• Must be able to communicate face-to-face and over the phone
• Occasional lifting up to 50 lbs.
• Frequent standing/walking. Occasional sitting, bending, twisting, kneeling, climbing, pushing/pulling and reaching.
• Repetitive hand and foot movement.
• Work environment includes occasional noise >85db, hot and cold temperatures.
• Requires ability to read, write, calculate and analyze.
• Requires good visual acuity with depth perception and color vision.

Benefits:

• Immediate Vacation – Vacation time is prorated based on your month of hire and available from day one.
• Paid Sick Leave – Up to 40 hours of paid sick time per year, prorated according to your start date.
• Competitive Compensation – Pay is based on your skills and experience.
• Comprehensive Benefits Package, including:
• • Medical, Dental, Vision, and Prescription coverage
  • Life and Disability Insurance
  • 401 (k) with Company Match
  • Health Savings Account (HSA) and Flexible Spending Account (FSA) options
  • Fitness Reimbursement Program
  • Education Reimbursement
  • Paid Holidays and more
  
  

Compensation:

• Starting Rate: $33.00

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor.