Pharma QA Supervisor: Compliance & Quality

JobRx, Inc.; Sugar Land (TX); On-site; USD 85,000 - 120,000; Full time

Benefits offered by this job

Health and wellness benefits

401k with match

Paid time off

Overtime opportunities with notice

Career advancement opportunities

Job summary

Quva seeks a Supervisor, Quality Assurance to lead QA on assigned shift, ensure compliance with FDA 503B and cGMP, and supervise QA staff throughout operations. You will oversee investigations, corrective actions, environmental monitoring, and disposition of finished products to meet specifications.

You will maintain QA records, calibrate testing equipment, develop QA policies, and communicate with Operations on product issues.

Qualifications

• High School diploma or equivalent required.
• Successful completion of drug and background check.
• 1 year of supervisory or management experience.
• 2 years' experience in Quality Assurance / cGMP / FDA regulated industry.
• Physical ability to lift up to 50 lbs., with or without accommodation.
• Must be authorized to work in the United States; no visa sponsorship.

Responsibilities

• Supervises Quality Assurance staff on assigned shift.
• Oversees failure and discrepancy investigations and documenting investigations on process deviations or equipment malfunctions.
• Develops and provides oversight to identification and implementation of appropriate corrective actions and preventive actions.
• Oversight of the environmental monitoring program including appropriate escalation of environmental and personnel monitoring results that exceed alert or action limits and interpreting results.
• Responsible for timely and accurate disposition of finished product to assure each batch meets specification prior to release.
• Periodically review records to verify that quality standards for each drug product is met.
• Maintain compliance with FDA 503B and cGMP guidelines / state and federal laws.
• Responsible for maintaining QA records associated with internal and external testing.
• Responsible to maintain all testing equipment in compliance, calibration, and certification.
• Assists in developing policies and procedures related to QA.
• Promptly communicates with Operations regarding complaints, product issues/variance.
• Assists in maintaining compliant controlled substance documentation specifically associated with sample handling and reconciliation.
• Enforces applicable personnel policies and procedures.

Skills

QA supervision

cGMP knowledge

FDA regulated industry

Attention to detail

Education

High School diploma or equivalent

Bachelor's Degree in Life Science

Tools

QA documentation tools

Job description

Quva seeks a Supervisor, Quality Assurance to lead QA on assigned shift, ensure compliance with FDA 503B and cGMP, and supervise QA staff throughout operations. You will oversee investigations, corrective actions, environmental monitoring, and disposition of finished products to meet specifications.

You will maintain QA records, calibrate testing equipment, develop QA policies, and communicate with Operations on product issues.