QA Specialist III

Validation-; Barceloneta (PR); Vor Ort; USD 80.000 - 110.000; Vollzeit

Zusammenfassung

Validation & Engineering Group, Inc. seeks a QA Specialist III to implement and maintain the Quality System and support manufacturing operations. You will resolve events, assess risk, review investigations, and provide guidance for product and process impact analyses.

You will also back up the QA Manager and participate in the Validation Review Board. The role requires strong English/Spanish communication, GMP knowledge, and technical writing skills, with the ability to work in a fast-paced

Qualifikationen

• Bachelor's degree in Biotechnology, Biology, Chemistry or Engineering; Masters Degree in Science preferred.
• Four years of experience in Pharmaceutical/Biotechnology industry preferred.
• Knowledge of GMP, safety regulations and regulatory guidance (cGxP).
• Excellent written and spoken communication skills in English and Spanish.
• Proficient with MS Windows and Microsoft Office applications.

Aufgaben

• Support routine operations to ensure quality goals are met and procedures comply with policies and regulations.
• Lead investigations and risk assessments; approve CAPA-related documents.
• Perform product impact analyses and place products on QA hold when needed.
• Participate in Validation Review Board as Manufacturing QA function.

Kenntnisse

MS Windows & MS Office

Technical Writing

Bilingual English/Spanish

GMP knowledge

Ausbildung

Bachelor's degree in Biotechnology, Biology, Chemistry or Engineering

Masters Degree in Science preferred

Jobbeschreibung

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:

• QA Specialist III

Description

Responsible for implementing and maintaining the effectiveness of the Quality System. Support manufacturing operations in the resolution of events, impact assessment and documentation discrepancies. Provide guidance for product/process impact analysis, perform holistic evaluation of events, review and approve investigations and risk based evaluations in support to routine operations and product disposition.

Responsibilities

• Support routine operations to ensure that all quality goals are met, and all practices and procedures comply with policies and applicable regulations for the Quality areas under responsibility. Serve as backup for the QA Manager leading the team and providing support to quality initiatives.
• Ensures investigations of plant events are evaluated in a timely manner; completed thoroughly and documented accurately in the plant CAPA system.
• Performs product impact analyses for plant events and places product on QA hold where appropriate.
• Participates on the Validation Review Board as the Manufacturing Quality Assurance function.
• Approves standard operating procedures; change management and risk management documents. Ensures all documents are in compliance with global procedures and regulatory requirements.
• Approves calibration requests, calibration out of tolerance and preventive maintenance records. Ensures that these documents have appropriate justifications according to product /process limits established.
• Demonstrates accountability and responsibility of EHS performance and compliance.
• Maintains an effective liaison and cooperative relationship with other Quality areas and Plant departments. Oversees manufacturing operations to ensure practices are in alignment with approved procedures.
• Provide support to the Compliance team during internal and external audits as required.
• Provide guidance for new product introduction activities. Develop risk assessments to support manufacturing activities for new products and ensure material control until regulatory approval.
• Conform to EHS management system requirements and compliance obligations, promote continuous improvement, and consider EHS aspects during the design and change process. Comply with all EHS procedures and policies including incident reporting, use of PPE, waste management and disposal, and any other program applicable according to the position duties.

Qualifications

• Bachelors degree in Biotechnology, Biology, Chemistry or Engineering. Masters Degree in Science preferred.
• Four (4) years of experience in Pharmaceutical/Biotechnology industry in a similar position.
• This position requires knowledge of quality / compliance /Investigations /Risk management as well as regulations and standards affecting biological products.
• Excellent written and spoken communication skills in English and Spanish.
• Knowledge of GMP, safety regulations.
• Quality/compliance management skills.
• Fast paced and adaptable to continuously changing environment. Subject to work with multiple priorities and interruptions and under reasonable pressure due to the nature and function of the area.
• Must be proficient using MS Windows and Microsoft Office applications.
• Strong knowledge in cGxP and regulatory guidance as well as understanding of how they are applied to regulatory compliance.
• Technical Writing skills and investigations processes.

Teamwork and time management skills.

• Available to work extended hours, possibility of weekends and holidays.

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.