Quality Assurance Services

Mentor Technical Group (MTG) provides a comprehensive portfolio of technical support and solutions for the FDA-regulated industry. As a world leader in life science engineering and technical solutions, MTG has the knowledge and experience to ensure compliance with pharmaceutical, biotechnology, and medical device safety and efficacy guidelines. With offices in Caguas, PR, Boston, MA & San Francisco, CA and we serve life sciences clients in six global markets: United States, Puerto Rico, Dominican Republic, Mexico, Germany, Canada, and South America.

Responsibilities:

• Evaluates documentation compliance for all manufacturing and support areas such as CR’s, SOP’s, BR’s, BOM’s, WPP’s, URS, qualification and validation Protocols, validation plans according with government regulations and employer Policies.
• Reviews and approves the CSV Installation and Operational Qualification Protocol (IOQ) for computerized systems, and/or automated manufacturing/laboratory equipment, processes, and systems with respective reports.
• Reviews and approves the Process/Laboratory Performance qualification protocols, Traceability Matrix document, and Validations reports among others.
• Review and approve equipment, utilities and facilities qualification and system lifecycle documentation.
• Reviews and approves all equipment, utilities, facilities, process, product and computer systems validation protocols and reports, change control documentation, reprocessing / rework operations, investigation reports related to manufacturing process and analytical and microbiology laboratory.
• Review/Approve equipment/facilities/system validation documents such as Users design Specifications (URS), Design Specifications(DQ), Risk Assessment(RA), Data Mapping/Data Flow/data Integrity, Audit Trail Review Applicability, Traceability Matrix, Installation, Operational and Performance Qualification, Validation Plan and Reports, DCS, QBASM and QBAS Design Specification and Qualification Documents, among others.
• Reviews/approve test script and manage revision/approval of the deviation investigation process ( initial phase, execution, final phase/approval) in the ALM environment or any other application system.
• Reviews and approves procedures related to process, products, utilities, and laboratories, and ensures compliance of all procedures (SOP’s-Operational and/or Administrative) to avoid potential regulatory and compliance issues.
• Supports, review and approves actively the investigation process occurred in manufacturing, warehouse, calibration, analytical and microbiology laboratory, facilities, and utilities areas related to process, products, utilities among others providing coaching from Quality perspective. Provides scientific input into investigations management to assure root cause and CAPAs are aligned with the opportunities identified in order to perform a systematic approach.
• Supports risk analysis process when a quality event has happened that cannot be solved immediately. This assessment needs to be completed to continue or prior to resumption of manufacturing process.
• Manages audit observation, investigations, change control and CAPAs records in Infinity System on timely manner.
• Participates in Manufacturing Alignment Teams (MAT) and Project Alignment Teams (PAT), department staff, planning and change control board meetings as required.
• Reviews and approved Commissioning Packages for utilities, manufacturing and Laboratory Facilities and equipment.
• Reviews and approves Corrective and Preventive actions (CAPA’s).

Qualifications Requirements/Knowledge/Education/Skills:

• Bachelor Degree in Science (Chemical, Engineering, Biology, Pharmacy or Microbiology)
• Six (6) years of experience in Quality Assurance responsibilities in a pharmaceutical industry
• Knowledge of laboratory instruments operations and background in pharmaceutical products manufacturing environment.
• Strong knowledge of relevant GMP, FDA, 21 CFR Part 11 and Data Integrity Regulations (Risk Assessment, Data Mapping etc), EU regulations and the ability to interpret and apply them for intended use
• Knowledge with network communications protocol (i.e. TCP/IP)
• Knowledge in Computerized System Validations.
• Acquainted with GAMP5 methodology for validations.
• Good skills revising validation/commissioning, and technical documentation in English and using MS Office applications.
• Fully bilingual (Spanish/English) communication skills, both written and verbal.
• Self-motivated, creative and teamwork oriented
• Technical and scientific capability to make firm decisions and recommendations
• Excellent interpersonal skills and the ability to interact with people at all levels
• Effective communication Skills
• Sense of urgency and analytical thinking
• Proficient knowledge of computer systems (Microsoft Office etc.) with data collection software (database) and applications like Infinity and SAP
• Solid ability for analyzing data detecting deviations, inconsistencies and interpret sampling test results
• Proficient knowledge of problem solving and root cause analysis methodologies (i.e. Kepner Tregoe)
• Willing to work irregular hours, rotative shifts, weekends and holidays when needed.

Mentor Technical Group es un empleador que ofrece igualdad de oportunidades y todos los solicitantes calificados recibirán consideración para el empleo sin importar raza, color, religión, sexo, orientación sexual, identidad de género, información genética, origen nacional, estado de veterano protegido, estado de discapacidad o cualquier otro grupo protegido por ley.

Mentor Technical Group is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.