Specialist QA (5:00 pm - 5:30 am)

Veg Group; Juncos (PR); Sur place; USD 80 000 - 110 000; Plein temps

Résumé du poste

Veg Group is seeking a Specialist QA to ensure regulatory compliance in pharmaceutical manufacturing. This role includes reviewing processes, approving critical documentation, and leading audits. Ideal candidates will have advanced degrees (Doctorate, Master's, Bachelor's) with relevant experience. Strong communication and organizational skills are essential for this position. Join a team dedicated to providing high-quality solutions in the pharmaceutical and biotechnology industries. The company offers a supportive environment focused on employee empowerment and development.

Qualifications

• Doctorate or Master’s degree with 2 years of related experience.
• 4 years of experience with Bachelor’s degree.
• Must have strong organizational and communication skills.

Responsabilités

• Review and approve product master plans.
• Approve process validation protocols and reports.
• Provide oversight for clinical and licensed pharmaceutical production.
• Support audits and inspections.

Connaissances

Experience with key electronic systems

Experience in computer systems validation

Strong communication skills

Leadership and negotiation skills

Bilingual proficiency in English and Spanish

Formation

Doctorate

Masters + 2 years of experience

Bachelors + 4 years of experience

Outils

SAP

TrackWise

LIMS

Maximo

Description du poste

Validation & Engineering Group, Inc. (V&EG), a Pinnaql company, is a leading services supplier providing solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.

We are seeking a talented, dedicated individual for the Specialist QA role (5:00 pm – 5:30 am).

SUMMARY

Perform one or more of the following duties and responsibilities in support of the Quality Assurance program under minimal supervision.

FUNCTIONS

• Review and approve product MPs.
• Approve process validation protocols and reports for manufacturing processes.
• Request Quality on incident triage team.
• Approve Environmental Characterization reports.
• Release of sanitary utility systems.
• Approve planned incidents.
• Represent QA on NPI team.
• Lead investigations.
• Lead site audits.
• Own site quality program procedures.
• Designee for QA manager on local CCRB.
• Review Risk Assessments.
• Support Automation activities.
• Support facilities and environmental programs.
• Review and approve Work Orders.
• Review and approve EMS/BMS alarms.
• Approve NC investigations and CAPA records.
• Approve change controls.
• Provide lot disposition and authorize lots for shipment.

EDUCATION

• Doctorate OR
• Masters + 2 years of directly related experience OR
• Bachelors + 4 years of directly related experience OR

RESPONSIBILITIES

• Execute Quality disposition (approval or rejection) of bulk drug substances.
• Provide Quality oversight to ensure that operations for clinical and licensed pharmaceutical Drug Substance (API) are manufactured, tested, stored, and managed according to current Good Manufacturing Practices (cGMP), Good Laboratory Practices (cGLP), and other applicable regulations.
• Ensure that deviations from established procedures are identified, reported, and documented per procedures.
• Ensure that changes that could potentially impact drug substance quality are assessed according to procedures.
• Ensure that production records and testing results are complete, accurate, and documented according to written procedures and cGMP requirements.
• Ensure that facilities, equipment, materials, organization, processes, and procedures align with cGMP practices and other applicable regulations.
• Champion continuous improvement initiatives, programs, and projects, including developing efficiency projects and supervising progress.
• Ensure completion of required training and maintain assigned training adherence to support successful task execution.
• Collaborate and partner cross functionally to ensure the Quality Management System (QMS) processes are completed in accordance with established procedures.
• Support internal and external audits and inspections as part of the audit/inspection management team, including acting as Quality Unit representative as needed.
• Alert senior management of quality, compliance, supply, and safety risks.
• Provide support and oversight for New Product Introduction (NPI).

ATTRIBUTES

• Experience with key electronic systems, such as documentation platforms (e.g., CDOCS), Maximo, TrackWise, LIMS, MES/electronic batch record systems, and SAP.
• Experience in computer systems validation (CSV) or computer systems quality assurance, including consulting level technical proficiency.
• Experience with validation of GxP applications, including Validation Master Plans, GxP risk assessments, IQ/OQ/PQ protocols, test scripts, and summary/approval reports.
• Robust knowledge of manufacturing and distribution processes, including QA, QC, and Process Development operations.
• Validated experience serving as Quality Contact for complex projects involving packaging, inspection, commissioning, qualification, and new drug substances/products.
• Strong organizational skills, with the ability to drive assignments through successful completion.
• Demonstrated leadership, influencing, and negotiation skills, including interactions with regulatory agencies and evaluation of compliance issues.
• Strong communication skills (written and oral), facilitation abilities, and full bilingual proficiency in English and Spanish, with the ability to work independently and effectively across all organizational levels.

At Validation & Engineering Group, people always come first. We believe that when you're empowered to do your best work, bold ideas thrive and real progress happens. This isn't just a job — it's an opportunity to make a meaningful difference by shaping the future of healthcare and technology alongside a purpose-driven, supportive team.

We look forward to hearing from you.

Validation & Engineering Group is an equal opportunity employer. All applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, or disability status.