GENERAL DESCRIPTION: The Quality Management Coordinator is responsible for reviewing documentation needed to determine and assign status to all material and finished product within the AVOA Quality Management, IFS and RF Gen systems of the company. This position requires collaboration with cross functional teams within the organization and a flexible work schedule to meet Company demands.
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Carry out final review of batch records for all finished product that is manufactured in-house as per company standard operating procedures.
- Assign product status (Release/Reject/Hold) on all finished goods manufactured in – house, from contract manufacturing companies, all raw material used for manufacturing of finished goods, and to all WIP.
- Responsible for creating all Certificates of Analysis (CoA’s) needed to facilitate product/material shipments.
- Scan and file all completed documentation required for the release process to include batch records and C of A’s in Company shared drives and quality system and submit all originals to Document Control.
- Update all spreadsheets for released goods.
- Comply with applicable regulations and conform to Company SOPs, Policies and standards.
MARGINAL JOB FUNCTIONS:
- Assist QM Coordinator II with handling of non-conforming products and coordination of material reviews as necessary.
- Assist Batch Record Coordinator with issuance of blank batch records and compilation of completed batch records as necessary.
- File and organize quality documents.
- Compile KPI data and carry out trend analysis for the release process.
- Assist with Quality and Regulatory audits, quality inspections and Management reviews as necessary.
- Assist with special projects delegated from management.
- Analytical skills
- Detail Oriented
- Collaboration skills
- Decision making
- Ethical conduct
- Focus on quality
- Interpersonal skills
- Learning orientation
- Organizational skills
- Personal effectiveness/creditability
- Problem solving/analysis
QUALIFICATIONS & SKILLS REQUIRED TO PERFORM JOB DUTIES:
- Ability to read, speak, write 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 including copy machine, fax, telephone, PC, and 10-key calculator.
- Knowledge of Good Manufacturing Practices (cGMPs).
PHYSICAL REQUIREMENTS TO PERFORM JOB DUTIES:
- Lift up to 20 lbs.
- Sit, stand, kneel, twist, turn and stoop.
- Use keyboard, computer and calculator.
- Reach forward and overhead as needed.
- Stand/remain upright for up to 4 or more hours at a time.
- Sit 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 relatable work experience in a similar industry.
If interested in this position, please send your resume to
Jason Maxwell, QA Manager at email@example.com