Quality Assurance Coordinator I

Position Title: Quality Assurance Coordinator I
Classification: Temp-Hire, Hourly,
Shift: M-F 8am-4:30pm
Department: Quality Management
Reports To: Quality Assurance Manager
Pay:$23.00-25.00hr.

General Description:

The Quality Assurance Coordinator I is responsible for reviewing documentation to determine and assign status to all material and finished products within the AVOA Quality Management, IFS, and RF Gen systems. This position requires collaboration with cross-functional teams and a flexible work schedule to meet company demands.

Essential Duties/Responsibilities/Functions:

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Documentation Review & Product Status Assignment:

  • Conduct final reviews of batch records for all finished products manufactured in-house per company SOPs.

  • Assign product status (Release/Reject/Hold) to finished goods, raw materials, and WIP, both in-house and from contract manufacturers.

• Certificates of Analysis (CoA):

  • Responsible for creating all necessary Certificates of Analysis (CoA) for product/material shipments.

• Document Management:

  • Scan, file, and maintain all completed documentation required for the release process, including batch records and CoAs, in company shared drives and the quality system.

  • Submit original documentation to Document Control.

• Data Management & Reporting:

  • Update all spreadsheets for released goods.

  • Compile Key Performance Indicator (KPI) data and perform trend analysis for the release process.

• Support to Quality Management:

  • Assist QM Coordinator II with handling non-conforming products and coordinating material reviews.

  • Assist Batch Record Coordinator with issuing blank batch records and compiling completed batch records.

• Audit & Compliance Support:

  • Assist with Quality and Regulatory audits, quality inspections, and Management reviews as necessary.

• Special Projects:

  • Assist with special projects delegated by management.

Supervisory Responsibilities:

• N/A

Competencies:

• Analytical skills

• Detail-oriented

• Accountability

• Collaboration skills

• Cooperation

• Decision-making

• Ethical conduct

• Focus on quality

• Independence

• Interpersonal skills

• Initiative

• Learning orientation

• Organizational skills

• Personal effectiveness/credibility

• Problem-solving/analysis

Qualifications & Skills Required:

• Ability to read, write, speak, and comprehend English.

• Computer proficiency: Intermediate to high proficiency in Microsoft Office and data entry.

• Knowledge of basic office procedures.

• Ability to operate office equipment (copy machine, fax, telephone, PC, 10-key calculator).

• Knowledge of Good Manufacturing Practices (cGMPs).

Physical Requirements:

• Able to lift up to 20 lbs.

• Ability to sit, stand, kneel, twist, turn, and stoop.

• Proficiency in using a keyboard, computer, and calculator.

• Ability to reach forward and overhead as needed.

• Ability to remain upright or sit for up to 4 or more hours at a time.

Education and/or Experience Required:

• High School Diploma or equivalent required.

• Bachelor of Science Degree preferred.

• 5 years of related work experience in a similar industry.

• Nesco Resource and affiliates (Lehigh G.I.T Inc, and Callos Resource, LLC) is an equal employment opportunity employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, disability, age, or veteran status, or any other legally protected characteristics with respect to employment opportunities.