Specialist QA

Veg Group; Juncos (PR); On-site; USD 90,000 - 120,000; Full time

Job summary

Validation & Engineering Group, Inc. (V&EG) is seeking a talented Specialist QA to join our compliance-driven team in Puerto Rico.

You will review and approve MPs, validation protocols, CAPA records, change controls and QA documentation, while leading investigations and audits. Applicants should have a Bachelor’s degree plus four years of directly related experience, strong leadership, cross-functional collaboration, and solid knowledge of QA, QAL, validation and process development within

Qualifications

• Bachelor’s degree plus 4 years of directly related experience.
• Experience with regulatory audits and CAPA processes.
• Strong ability to lead cross-functional teams.
• Experience in QA, QAL, validation and process development.

Responsibilities

• Review and approve product MPs.
• Approve validation protocols and reports for manufacturing processes.
• Lead investigations.
• Lead site audits.
• Own site quality program procedures.
• Designee for QA manager on CCRB.
• Review Risk Assessments.
• Provide lot disposition and authorize lots for shipment.

Skills

Project management

Cross-functional leadership

Regulatory interaction

QA/QAL experience

Process validation

Data analysis

Education

Bachelor's degree + 4 years of directly related experience

Tools

Word processing

Presentation software

Database

Spreadsheet

Job description

Current job opportunities are posted here as they become available.

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

We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:

• Specialist QA

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

• Bachelors + 4 years of directly related experience

COMPETENCIES/SKILLS

• Project management skills.
• Strong organizational skills, including ability to follow assignments through to completion.
• Initiate and lead cross functional teams.
• Enhanced skills in leading, influencing and negotiating.
• Strong knowledge in area of expertise.
• Collaborate and coordinate with higher level outside resources.
• Strong knowledge of and experience with processes involved in manufacturing and distribution, QA, QAL, validation and process development.
• Demonstrate ability to interact with regulatory agencies.
• Strong word processing, presentation, database and spreadsheet application skills.
• Strong communication (both written and oral), facilitation and presentation skills.
• Strong skill in working independently and to effectively interact with various levels.
• Advanced data trending and evaluation.
• Ability to evaluate compliance issues.
• Demonstrate the Amgen Values/Leadership Practices.

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.

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.