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SUMMARY: Perform one or more of the following duties and responsibilities in support of Amgen's 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....

*EDUCATION:*-Doctorate OR-Masters + 2 years of directly related experience OR-Bachelors + 4 years of directly related experience OR-Associates + 8 years of directly related experience OR-High school/GED + 10 years of directly related experience.*QUALIFICATIONS:** NPI, Change Control, FATs, Validation, and PPQs*SHIFT: ** AdministrativePay: $***** - $***** per...

EDUCATION: -Doctorate OR -Masters + 2 years of directly related experience OR -Bachelors + 4 years of directly related experience OR -Associates + 8 years of directly related experience OR -High school/GED + 10 years of directly related experience. QUALIFICATIONS: NPI, Change Control, FATs, Validation, and PPQs SHIFT: Administrative Pay: $***** - $***** per...

Hourly Wage: $13 - $26 per/hour • The actual hourly rate will equal or exceed the required minimum wage applicable to the job location. Additional Compensation Includes Annual Or Quarterly Performance Incentives. Additional compensation in the form of premiums may be paid in amounts ranging from $0.35 per hour to $3.00 per hour in specific...

Description We are seeking an experienced Specialist Manufacturing – Supplier Change Control professional to manage supplier-related Change Control Records within a regulated pharmaceutical or biotechnology environment. The ideal candidate will have at least 5 years of relevant professional experience, with hands-on responsibility for managing Change...

*Description*We are seeking an experienced Specialist Manufacturing – Supplier Change Control professional to manage supplier-related Change Control Records within a regulated pharmaceutical or biotechnology environment.The ideal candidate will have at least 5 years of relevant professional experience, with hands-on responsibility for managing Change...

**At Kelly® Science, we’re passionate about helping you find a job that works for you. How about this one?** We’re seeking **Specialist Manufacturing** to work for one of our top **Biotechnology Industry client at Juncos, PR** . **Salary: $38.00 hr** **Administrative shift** - **Responsibilities:** Support the execution of manufacturing/quality...

For Change Management services in the Capital Projects area.WHAT MAKES YOU A FIT:The Technical Part:Bachelor's degree in Engineering or Life Sciences and at least five (5) years of experience in Change Management activities within the Pharmaceutical & Medical Devices Industry.Bilingual: Spanish and EnglishSoft Skills: Excellent Communication skills, and...

For Change Management services in the Capital Projects area. **WHAT MAKES YOU A FIT: .png)** **The Technical Part:** - Bachelor’s degree in Engineering or Life Sciences and at least five (5) years of experience in...

For Change Management services in the Capital Projects area. **WHAT MAKES YOU A FIT:** **The Technical Part:** - Bachelor’s degree in Engineering or Life Sciences and at least five (5) years of experience in Change Management activities within the Pharmaceutical & Medical Devices Industry. - Bilingual: Spanish and English - Soft Skills: Excellent...

**SUMMARY:** **Are there specific educational/software requirements needed?** -Doctorate + 2 years of Project Management experience OR -Masters + 4 years of Project Management experience OR -Bachelors + 6 years of Project Management experience OR -Associates + 10 years of Project Management experience OR -High school/GED + 12 years of Project...

Job Title: Documentation Specialist ILocation: Barceloneta, PR *****Duration: 12+ months (possible extension)Pay Rate: $*****/hrShift: 10:30 AM 7:00 PMMust be available to work overtime and weekends based on business needs.General Position Summary/Purpose:The Documentation Specialist is responsible for managing documentation processes, ensuring documents are...

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,...

Provide Quality oversight for drug product operations at a leading biotechnology company in Juncos, Puerto Rico, with a focus on new product introductions, change control and validation. You will work with minimal supervision and make the quality calls that keep projects and product moving. What you'll do • Represent QA on new product introduction (NPI)...

For Quality Engieneering services in the CTW and Sustaining Projects area.WHAT MAKES YOU A FIT:The Technical Part:Bachelor's degree in Engineering, Science, or a related technical discipline, with 3–5+ years of relevant Quality Engineering experience in the medical device, pharmaceutical, or other highly regulated manufacturing industry.Bilingual, Spanish...

For Quality Engieneering services in the CTW and Sustaining Projects area. WHAT MAKES YOU A FIT: The Technical Part: Bachelor's degree in Engineering, Science, or a related technical discipline, with 3–5+ years of relevant Quality Engineering experience in the medical device, pharmaceutical, or other highly regulated manufacturing industry. Bilingual,...

Associate Quality Analyst Purpose : Provide leadership and direction in all aspects of quality processes that manage nonconformance and CAPA, Change Control and Risk Management. Responsibilities : Monitor performance through appropriate Key Performance Indicators (KPIs) for CAPA, Change Control, and Risk Management. Ensure a timely completion of actions...

Title: Associate Quality Analyst ILocation: Barceloneta PRDuration: 12+ MonthsPay Range: $20/hr. - $24/hr.Purpose :Describes the primary goals, objective or function or outputs of this position.Provide leadership and direction in all aspects of quality processes that manage nonconformance and CAPA, Change Control and Risk Management.Responsibilities :Monitor...

Analyze the performance of Production and Maintenance processes and implement sustainable, data-driven improvements to enhance safety, quality, reliability, productivity and operational efficiency. The Operations Specialist serves as Operations' primary technical resource for continuous improvement, reliability and digital systems adoption. The position...

mîrus Consulting Group is a local company based in Humacao, Puerto Rico that provides computer system validation and information technology consulting services to pharmaceutical companies and other organizations across the Island and parts of the United States. Its services include the assessment and validation of automation equipment, network...