Empleos actuales relacionados con QA Associate, Quality Operations - Juncos - BioPharma Consulting JAD Group
-
Specialist QA
hace 55 minutos
Juncos, Puerto Rico Inteldot A tiempo completoInteldot has over 14 years in the life sciences industry, with operations across Puerto Rico, the United States, Europe, and Japan. This is a great opportunity for one of our leading clients in Puerto Rico.Job Description:Under minimal supervision, support Quality Assurance program by performing a variety of key responsibilities in manufacturing, process...
-
Specialist QA
hace 55 minutos
Juncos, Puerto Rico Mentor Technical Group A tiempo completoMentor Technical Group (MTG) provides a comprehensive portfolio of technical support and solutions for the FDA-regulated industry. As a world leader in life science engineering and technical solutions, MTG has the knowledge and experience to ensure compliance with pharmaceutical, biotechnology, and medical device safety and efficacy guidelines. With offices...
-
Specialist QA
hace 2 semanas
Juncos, Puerto Rico BioPharma Consulting JAD Group A tiempo completoThe Quality Assurance Specialist provides quality oversight and support for regulated manufacturing operations, ensuring compliance with current Good Manufacturing Practices (cGMP), regulatory requirements, and internal quality systems. This role performs QA review, approval, and leadership activities under minimal supervision and serves as a key quality...
-
Specialist Quality Control
hace 55 minutos
Juncos, Puerto Rico BioPharma Consulting JAD Group A tiempo completoThe position focuses on complex technical issues, multi-department and/or multi-site initiatives, and coordination with external resources when needed. Responsibilities include advanced troubleshooting, method support, documentation oversight, compliance, and cross-functional leadership.Key ResponsibilitiesProvide technical guidance and ensure effective...
-
Specialist Manufacturing
hace 55 minutos
Juncos, Puerto Rico Inteldot A tiempo completoInteldot has over 14 years in the life science industry with allocations a cross Puerto Rico, United Sates, Europe and Japan. This is a great opportunity for one of our leading clients in Puerto Rico. Administrative shift (8 hours)Job Description:Support the execution of manufacturing/quality systems such as non-conformances, process validation, procedures,...
-
Quality Control Specialist
hace 55 minutos
Juncos, Puerto Rico Mentor Technical Group A tiempo completoMentor Technical Group (MTG) provides a comprehensive portfolio of technical support and solutions for the FDA-regulated industry. As a world leader in life science engineering and technical solutions, MTG has the knowledge and experience to ensure compliance with pharmaceutical, biotechnology, and medical device safety and efficacy guidelines. With offices...
-
Engineer
hace 55 minutos
Juncos, Puerto Rico BioPharma Consulting JAD Group A tiempo completoUnder general supervision, the Manufacturing/Process Engineer provides technical support for process optimization, troubleshooting, and operational improvements in manufacturing, pilot plant, or capital projects. Applies basic engineering principles to implement system modifications, experiments, and capital projects, while organizing, analyzing, and...
-
Specialist Quality Control 34863
hace 55 minutos
Juncos, Puerto Rico Inteldot A tiempo completoInteldot has over 14 years of experience in the life sciences industry, with allocations across Puerto Rico, the United States, Europe, and Japan. This is a great opportunity for one of our leading clients in Puerto Rico.Job DescriptionUnder general direction, functions as the technical specialist for testing and development in areas of molecular biology and...
-
Senior Associate Manufacturing Systems
hace 55 minutos
Juncos, Puerto Rico BioPharma Consulting JAD Group A tiempo completoThe Senior Associate, Manufacturing Systems (Automation) provides technical engineering support for system and equipment optimization, upgrades, replacements, and modifications. This role ensures that maintenance operations are performed in full compliance with corporate policies, industry standards, regulatory guidelines, and FDA requirements. The...
-
Associate Tech Engineering
hace 55 minutos
Juncos, Puerto Rico BioPharma Consulting JAD Group A tiempo completoThe Associate Technical Engineer (Automation) provides hands-on automation and technical support for system and equipment optimization, upgrades, replacements, and modifications. This role ensures that all supported areas operate in compliance with corporate policies, industry standards, regulatory requirements, and FDA guidelines. The position supports...
QA Associate, Quality Operations
hace 2 semanas
The QA Associate, Quality Operations is a floor-facing Quality Assurance role that supports day-to-day manufacturing operations in a GMP-regulated environment. This position was opened due to increased team activity and requires strong collaboration with cross-functional partners across Manufacturing, Quality Control, Validation, Engineering, Facilities, and Materials. The role is ideal for an early-career QA professional with hands-on GMP experience who is comfortable working on the production floor and engaging with diverse teams.
Key Responsibilities
- Provide on-the-floor QA support to manufacturing operations, including area clearance, line clearance, and changeover activities to ensure production readiness.
- Support raw material processes, including review and approval of incoming material documentation and release for GMP use.
- Review and approve SOPs, Master Batch Records (MBRs), specifications, risk assessments, and other GMP documentation.
- Generate, revise, and maintain quality-related SOPs and controlled forms.
- Perform executed batch record review and approval to ensure accuracy, completeness, and compliance.
- Review and approve deviations, CAPAs, change controls, and associated investigations within the quality management system.
- Review and approve validation protocols, reports, and protocol executions in alignment with regulatory and site requirements.
- Review and approve QC laboratory qualification and equipment qualification documentation.
- Approve work orders in maintenance systems to verify equipment maintenance and calibration compliance.
- Support inspection readiness activities, partner audits, and regulatory inspections, including document retrieval and subject matter support.
- Collaborate closely with cross-functional teams to drive continuous improvement and promote a strong quality culture.
Technical Skills
- Experience using quality and enterprise systems such as:
- SAP (highly used)
- Veeva Vault (highly used)
- LIMS (plus)
- Infor / CMMS systems (nice-to-have)
- Proficiency in reviewing and managing GMP documentation and quality system records.
Requirements
Qualifications & Experience
- Bachelor's degree in a scientific or engineering discipline (e.g., Biology, Chemistry, Biotechnology) required.
- Minimum of 2 years of professional GMP experience; 2–4 years preferred.
- Open to candidates with up to ~10 years of experience, provided GMP exposure aligns with the role scope.
- At least one role with direct, hands-on GMP experience.
- Experience supporting manufacturing or operational environments required.
- Knowledge of cGMP regulations (21 CFR Parts 210/211/11, ICH Q7/Q10) and Good Documentation Practices (GDP).
Benefits
- 9-month contract
- Administrative shift
