Specialist QA

Validation & Engineering Group, Inc.; Juncos (PR); On-site; USD 70,000 - 100,000; Full time

Job summary

Validation & Engineering Group, Inc. (V&EG) is seeking a Specialist QA to support the Quality Assurance program under minimal supervision in our pharma and biotech focused operations in Puerto Rico.

You will review MPs, approve validation protocols, lead investigations, and coordinate site audits while ensuring regulatory alignment and efficient release of manufactured lots. The ideal candidate has advanced degrees (PhD or MS with relevant experience) and strong cross-functional leadership,

Qualifications

• Doctorate or
• Masters plus 2 years of related experience or
• Bachelors plus 4 years of related experience

Responsibilities

• 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.

Skills

Project management

Organizational skills

Cross-functional leadership

Communication skills

Regulatory interactions

QA processes

Documentation skills

Independent work

Data trending

Education

Doctorate

Masters + 2 years of directly related experience

Bachelors + 4 years of directly related experience

Job description

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

Summary

Perform one or more of the following duties and responsibilities in support of 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

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.