Quality Assurance Supervisor-10Am To 6:30Pm

SUMMARY

The Quality Assurance Supervisor is responsible for assisting with investigations, training, and Document Control.

Quality Assurance Supervisor is responsible for setting the standard for professionalism in the workplace at Wells Pharma of Houston.

This position supervises the daily function of Quality Assurance: Release of finished product, verifying the building monitoring system, reviewing validation/ qualification documents, and revision of SOPs.

ESSENTIAL DUTIES AND RESPONSIBILITIES

· Familiarity with quality standards and processes to follow federal, state, and local regulations

· Communication skills to convey information in reports, meetings, and status reports

· Knowledge of the processes to perform thorough quality audits, assessments and or approval

· Analysis, critical-thinking and problem-solving skills to investigate non-conformances and identified gaps in processes

· Assist in the release of finished goods to ensure it meets specification per USP/FDA/WPH by reviewing laboratory test results, environmental data, monitoring data, visual inspection data, and label reconciliation.

· Oversee visual inspection to ensure SOPs are followed and equipment is calibrated and functional per its intended use.

· Ensure Visual Inspectors training is current and eye exams are performed per FDA requirement

· Ensure batch release/finished goods meet all acceptance criteria before release for order fulfillment.

· Ensuring that products adhere to quality standards for release of drug products

· Assisting with the initiation of non-conformance reports by collecting, analyzing, and summarizing data using the DMAIC tools

· Assist with the training and managing of CAPA, Deviations, and OOS investigations

· Ability to work together with a cross-functional team

· Participate in the management of associated Quality Systems, monitoring effectiveness of Quality Systems and providing updates to Senior Quality management.

· Initiate the revision of appropriate SOPs through review, revision and approval processes.

· Ensure associates are adhering to the procedures/regulations in designated GMP areas as it relates to ISO standards, GxP standards with emphasis on cGMP, and current industry compounding practices.

· Ability to manage a team to ensure QA tasks are completed in a timely manner, particularly visual inspection and batch release.

· Complete other duties as requested by senior management.

Job Type: Full-time

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Employee assistance program
• Flexible spending account
• Health insurance
• Life insurance
• Paid time off
• Vision insurance

Schedule:

• 8 hour shift
• Monday to Friday

Application Question(s):

• Do you have an Associate Degree in Science or in a related field, plus 5 to 7 years of related experience? REQUIRED
• Do you have a very strong understanding of GXP as it pertains to 21 CFR 210, 211 and 503B regulated environments? REQUIRED
• Do you have recent experience with validation of aseptic drug product, calibration and validation of critical equipment, and bulk manufacturing process? Preferred
• Do you have knowledge of 21 CFR parts: 503B, 210, 211 and other related regulatory and industry standardards?

Work Location: In person