Specialist QA

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)