Position is responsible for quality oversight and assistance to production processes, supporting departments and laboratories. Position recommends corrective action in response to deviations noted. Assures compliance to SOP’s and cGMP’s. Maintains the finished product reserve, appropriate sampling and FDA retention sample storage areas.

• The MQA Specialist will drive a culture of continuous quality improvement by on the shop-floor presence. Act with competency, integrity and appropriately as Quality Assurance personnel and assure that the processes required are adhered to.
• Authorized to stop production activities and contain materials and/or products with immediate effect where Critical Deviations are noted. Escalate Isolated and Systemic issue to site management, including proposed CAPAs. Is the QA key contact to shop floor employees. On the floor QA contact to escalate issues and provide real-time documentation requirements/trouble shooting analysis.
• Participates in 5S activities. Support in investigations & root-cause analyses (incidents & investigations).
• Shop-floor documentation review of MBRs and logbooks for GMP and procedural compliance. Support quality and compliance and continuous Improvement projects.
• Special oversight activities based on case by case demand.

Requirements

• Minimum of High School Diploma with one (1) to three (3) years of work experience required
• Associate degree or High School diploma with previous related field experience or knowledge of a GMP – regulated industry preferred
• Candidates must have knowledge of the competencies as described below and complete the required training activities in the defined timelines:
• o Knowledge & expertise in regulatory requirements and industry /company best practices approaches
• Competency in different computerized system (including software)
• Knowledge of Word/Access and Excel applications is a plus
• Aptitude for understanding of the technology employed in production activities
• Organizational abilities, troubleshooting capabilities, stress resilience, personal integrity
• Relevant work experience/functions (production activities)

Job Type: Full-time

Pay: $20.53 - $24.72 per hour

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Flexible spending account
• Health insurance
• Life insurance
• Paid time off
• Tuition reimbursement
• Vision insurance

Schedule:

• Day shift

Ability to commute/relocate:

• Melrose Park, IL 60164: Reliably commute or planning to relocate before starting work (Required)

Work Location: One location

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