Specialist QA

QRC Group, LLC•Juncos, PR

About The Position

We are seeking a Specialist QA to 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. The role involves actively engaging in continuous improvement initiatives, programs, and projects, and vigilantly ensuring that changes potentially impacting product quality are assessed according to procedures. The Specialist QA will certify that deviations from established procedures are investigated and documented per procedures, ensure on-the-floor triage is completed, documented, and current procedural controls are achieved, including ensuring the initiation of deviation records. This role ensures that production records and testing results are complete, accurate, and documented according to written procedures and cGMP requirements. It requires 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. The Specialist QA will serve as a strategic advisor to senior management regarding quality, compliance, supply, and safety risks, and support internal/external audits and inspections as part of the audit/inspection management team, including acting as Quality unit representative as needed. This role is accountable for adherence to assigned training and permitting execution of required tasks. The Specialist QA will champion continuous improvement initiatives and projects, provide support and oversight for New Product Introduction (NPI), and demonstrate validated expertise in Quality Systems such as deviations, CAPA, and change control. The role requires robust knowledge and experience with processes involved in manufacturing and distribution, QA, QAL, and Process Development.

Requirements

Bachelor’s degree in Science or Engineering + 4 years of directly related experience
Strong communication skills in English and Spanish (both written and oral), facilitation, and presentation skills.
Validated experience in commissioning and qualification.
Validated experience serving as Quality Contact for complex projects involving new products.
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.
Exhibit experience in computer systems validation or computer systems quality assurance, particularly with medical devices and/or consulting background technical proficiency.

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.
Possess robust knowledge and experience with processes involved in manufacturing and distribution, QA, QAL, and Process Development.
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.
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.