The Role
Performs plant quality assurance reviews, batch record approvals, deviation and CAPA oversight, validation activities, and change-control assessments in regulated manufacturing environments. Supports audits, inspections, commissioning, qualification, new product introduction, and quality management systems. Advises management on quality and compliance risks, collaborates cross-functionally, evaluates compliance issues, and leads continuous improvement initiatives. Requires strong English and Spanish communication skills, regulatory interaction experience, and expertise with GxP applications and computer systems validation.
Summary Generated by Built In
We are seeking a Sr. Specialist QA with experience in regulated industries:
Responsibilities:
- Perform On-the-floor Plant Quality Assurance (PQA) review, approval, and tracking of cGMP processes, procedures, testing methods in manufacturing, documents and records, batch record review, MES, EBR, SAP, EDMQ, DQMS, Trackwise; including but not limited to deviations, CAPAs, and validations.
- Actively engage in continuous improvement initiatives, programs, and projects.
- Vigilantly ensure that changes potentially impacting product quality are assessed according to procedures.
- Certify that deviations from established procedures are investigated and documented per procedures and ensure on-the-floor triage is completed, documented, and current procedural controls are achieved, including ensuring the initiation of deviation records.
- Ensure that production records and testing results are complete, accurate, and documented according to written procedures and cGMP requirements.
- Require strong collaboration and cross-functional partnership to ensure the Quality Management System, Manufacturing, Process Development, Validation, Quality Control, Warehouse, Engineering, Contractors, Environmental, Facilities, and other processes are executed according to established procedures.
- Serve as a strategic advisor to senior management regarding quality, compliance, supply, and safety risks.
- Support internal/external audits and inspections as part of the audit/inspection management team, including acting as Quality unit representative as needed.
- Accountable for adherence to assigned training, permitting execution of required tasks.
- Champion continuous improvement initiatives and projects.
- Provide support and oversight for New Product Introduction (NPI).
- Demonstrate validated expertise in Quality Systems such as deviations, CAPA, and change control.
- Exhibit experience in computer systems validation or computer systems quality assurance, particularly with medical devices and/or consulting background technical proficiency.
- Possess robust knowledge and experience with processes involved in manufacturing and distribution, QA, QAL, and Process Development.
- Experience with validation of GxP applications, including development of Validation Master Plan, Installation Qualification (IQ), Risk Assessment/GxP assessment, Operational Qualification (OQ), and Performance Qualification (PQ) protocols, test scripts, and completion/summary report approvals per compliance requirements.
- Validated experience serving as Quality Contact for complex projects involving new products.
- Validated experience in commissioning and qualification.
- Strong organizational skills, including the ability to follow assignments through to completion.
- Enhanced skills in leading, influencing, and negotiating.
- Demonstrate the ability to interact effectively with regulatory agencies.
- Solid word processing, presentation, database, and spreadsheet application skills.
- Strong communication skills in English and Spanish (both written and oral), facilitation, and presentation skills.
- Proven skill in working independently and effectively interacting with all levels throughout the organization.
- Advanced data trending and evaluation abilities.
- Ability to evaluate compliance issues.
Requirements
- Education: Bachelors Degree in Science or Engineering + 4 years of directly related experience.
- Bilingual (English & Spanish)
Skills Required
- Bachelor’s degree in Science or Engineering
- Four years of directly related experience
- Bilingual proficiency in English and Spanish
- Experience in regulated industries and cGMP manufacturing environments
- Experience with quality systems, including deviations, CAPA, and change control
- Experience with computer systems validation or computer systems quality assurance
- Experience validating GxP applications, including IQ, OQ, PQ, risk assessments, and validation documentation
- Experience with commissioning and qualification
- Experience supporting audits, inspections, and regulatory agency interactions
- Advanced data trending and evaluation skills
Am I A Good Fit?
Get Personalized Job Insights.
Our AI-powered fit analysis compares your resume with a job listing so you know if your skills & experience align.
Success! Refresh the page to see how your skills align with this role.
The Company
What We Do
QRC Group specializes in providing expert consulting services in regulatory compliance, quality management, and risk management for the pharmaceuticals, medical devices, biotechnology, and other regulated industries, delivering comprehensive project management and validation solutions.
