Quality Assoc I

POSITION SUMMARY

The primary responsibility of this position is to provide Quality Assurance and Quality

Control activities to support Production. This role will also ensure compliance with all applicable regulatory mandates, customer specific requirements, as well as conduct routine audits and inspections at various stages of production. This role 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.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Conduct various Quality audits and inspections.

o In-process

o Line audits

o Start-ups and changeovers

o Finished Goods

o Trailers

o Incoming raw materials.

o 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. This will include 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.
• Will 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.

EDUCATION and/or EXPERIENCE

Minimum Education Details:

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