Quality Assurance Specialist

PCCA•Houston, TX

30d

About The Position

This role focuses on ensuring compliance with Good Manufacturing Practices (GMP), internal procedures, and regulatory requirements. The specialist will collaborate with management to investigate quality issues, develop preventative strategies, and report concerns to Quality Management. Key responsibilities include managing customer product complaints, conducting investigations, and providing customer support. The role also involves maintaining quality systems, managing data, performing internal audits, and overseeing equipment calibration to ensure adherence to GMP standards.

Requirements

Experience in quality assurance and GMP compliance.
Ability to investigate quality issues and develop preventative strategies.
Proficiency in technical writing for clear and concise documentation.
Experience with complaint management and root cause analysis.
Familiarity with quality systems and data management.
Experience performing internal audits.
Knowledge of equipment calibration and maintenance procedures.
Ability to review and approve calibration certificates and maintenance records.

Nice To Haves

Experience with MasterControl system administration.
Experience participating in external audits by regulatory agencies.
Strong customer support skills via phone and email.

Responsibilities

Support compliance with Good Manufacturing Practices (GMP), internal procedures, and regulatory requirements.
Collaborate with department management to investigate quality issues and develop strategies to prevent recurring deviations.
Report potential quality or compliance concerns to Quality Management in a timely manner.
Create, update, and review Standard Operating Procedures (SOPs) and other controlled documents in compliance with GMP requirements.
Lead, initiate, track, and trend investigations related to customer product complaints.
Review reported complaints for accuracy and completeness prior to triaging.
Assist subject matter experts with root cause analysis and corrective action activities.
Utilize technical writing practices to ensure investigations are clear, concise, and well-documented.
Provide customer support related to product complaints through phone and email communication.
Compile, maintain, and analyze quality performance metrics and trend data.
Support MasterControl system administration activities, including troubleshooting and process improvements.
Maintain accurate and compliant quality records and documentation.
Perform internal audits to assess compliance with regulatory, quality, and procedural requirements.
Participate in external audits conducted by regulatory agencies and provide documentation and audit support as needed.
Support continuous improvement initiatives resulting from audit findings and quality trends.
Ensure equipment calibrations are completed according to defined schedules and GMP requirements.
Review and approve calibration certificates and maintenance records to verify equipment remains within acceptable operating parameters.
Coordinate follow-up activities related to equipment calibration or maintenance issues.