Inteldot has over 15 years in the life sciences industry, with operations across Puerto Rico, the United States, Europe, and Japan. This is a great opportunity for one of our leading clients in Puerto Rico.
Administrative Shift
Job Description:
Under minimal supervision, support Quality Assurance program by performing a variety of key responsibilities in manufacturing, process validation, regulatory compliance, and quality assurance activities.
Requirements & Qualifications:
- 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.
Functions:
- 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).
Education
- Bachelor’s degree in Science or Engineering + 4 years of directly related experience
