Quality Assurance (QA) Specialist II

Pinnaql; Barceloneta (PR); On-site; USD 65,000 - 90,000; Full time

Job summary

Validation & Engineering Group Inc V&EG a Pinnaql company is seeking a dedicated QA Specialist II for a rotating 4-day, 10-hour shift to uphold the quality system and ensure regulatory compliance across pharmaceutical, biotechnology and related operations.

The role involves supporting manufacturing, leading investigations, CAPA and change management, and serving as a QA back-up to the QA Manager while maintaining rigorous documentation and EHS alignment.

Qualifications

• Bachelor's degree in Biotechnology, Biology, Chemistry or Engineering.
• Masters Degree preferred; four years of experience in Pharmaceutical/Biotechnology.
• Knowledge of GMP and safety regulations.
• Excellent written and spoken communication in English and Spanish.

Responsibilities

• Implement and maintain effectiveness of Quality System.
• Support manufacturing operations in events resolution and documentation discrepancies.
• Provide guidance for product/process impact analyses and investigations.
• Approve SOPs, change management and risk management documents.
• Ensure documents comply with global procedures and regulatory requirements.
• Support internal/external audits and new product introductions.

Education

Bachelor's degree in Biotechnology/ Biology / Chemistry / Engineering

Masters Degree preferred

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 Quality Assurance QA Specialist IIShift Associate Rotating shift 4 days at 10hours

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 productprocess 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 preferredFour 4 years of experience in PharmaceuticalBiotechnology 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
• Qualitycompliance 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
• Assures the quality of manufactured products and processes per standard operating processes SOPS and GMP Good Manufacturing Practices
• BS degree or 3 5 years equivalent experience
• Technical Writing skills and investigations processes
• Available to work extended hours possibility of weekends and holidays

At Validation & Engineering Group people always come first We believe that when youre empowered to do your best work bold ideas thrive and real progress happens This isnt just a job its an opportunity to make a meaningful difference by shaping the future of healthcare and technology alongside a purpose driven supportive team Excited to build something meaningful together 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