Quality Assoc I

About the role

The primary responsibility of this position is to provide Quality Assurance and Quality Control activities to support Production. This role ensures compliance with all applicable regulatory mandates, customer-specific requirements, and conducts routine audits and inspections at various stages of production. It is responsible for detecting and reporting all findings of non-conforming raw materials, finished product, and goods as the initial point of prevention and appraisal.

Responsibilities

• Conduct various Quality audits and inspections:
  • In-process/Line audits
  • Start-ups and changeovers
  • Finished Goods
  • Trailers
  • Incoming raw materials
  • GMP Audits
• Identify and report any nonconformances and process deviations.
• Maintain cGMP-compliant documentation of Production and Quality records.
• Assist with Stability, Reserve, and USP Sampling Programs.
• Review guidance and documents as directed for alignment with current processes.
• Observe processes for reporting systemic improvement opportunities.
• Complete and submit Laboratory Requests.
• Collect Environmental monitoring data.
• Review Daily Batch Records and other Quality records for GDP errors and GMP compliance.
• Identify and place any non-conforming material or products on Quality Hold, including physical placarding, quarantining, and system Quality Holds.
• Assist with product returns and make appropriate notifications.
• Maintain cleanliness and organization of all Quality areas.
• Maintain Quality Hold Logs and the Disposition of products.
• Data Entry (Logbooks and Spreadsheets).
• Assist Supervisor with maintaining Daily Compliance Logs.
• Coordinate with training staff to educate employees on Good Manufacturing Practices, Good Documentation Practices, and Safety and Housekeeping Policies.
• Assist Production Supervisors and the Training Dept. with employee training.
• Maintain and organize Document/Record Storage.
• Report observations of unsafe working conditions to management.

Requirements

• High school diploma or GED.
• No prior experience required; however, prior experience is preferred.

Benefits

• Medical
• Prescription Drug
• Dental
• Vision
• Health Care Reimbursement Account
• Dependent Care Reimbursement Account
• Wellness Programs
• Employee Assistance Plan
• Paid Holidays and Vacation
• 401(k) with Company matching
• Pension
• Salary Continuation – Short-Term Disability
• Long-Term Disability Options
• Employee Life Insurance
• Spouse & Dependent Life Insurance
• Business Travel Accident Insurance
• Direct Deposit Payroll
• Educational/Tuition Assistance Plan
• College Scholarship Program – for dependent children
• Matching Gift Program
• New Auto Purchase Discount Plans