Lab Assistant Confidence Validation Services

Sartorius; Yauco (PR); On-site; USD 65,000 - 90,000; Full time

Benefits offered by this job

Paid vacation

Medical insurance

On-site facilities

Job summary

Sartorius is seeking a QA/Validation Specialist to support qualification and validation activities at our Puerto Rico facility. You will perform viability and compatibility testing, handle materials, prepare media, and maintain lab data and SOPs. Must be self-motivated with strong organizational and communication skills.

Ideal candidates hold a sciences/engineering degree, 3+ years in pharma, and solid GMP knowledge. Experience with microbiological testing and cross-functional teamwork is a plus.

Qualifications

• Academic or technical degree in sciences / engineering or similar.
• Minimum of 3 years of relevant experience (including academic training).
• Experience in the pharmaceutical industry is a plus.
• Good understanding of GMP requirements.
• Familiar with microbiological analysis testing and operating related equipment.

Responsibilities

• Provide qualification / validation quality / compliance support per Sartorius SOPs.
• Perform viability, bacterial challenge, product integrity and chemical compatibility tests.
• Perform in-coming material testing.
• Prepare strains, culture media, test solutions and reagents.
• Handle indicators, cultures, chemicals and test solutions per regulations and SOPs.
• Complete laboratory data forms, interpret results and review.
• Inform lab manager of deviations related to validation protocols.
• Initiate investigations related to deviations or out of specification results.
• Perform cleaning and sanitizing of lab and equipment.
• Check daily monitoring data of lab environment and equipment.
• Inventory control of consumables and reagents for safe stock.
• Qualification, calibration and maintenance of equipment; review protocols/reports.
• Assist in maintenance of SOPs, including writing/revising documents.

Skills

GMP knowledge

English fluency

Problem solving

Communication

Project management

Teamwork

Microsoft Office

Education

Science/Engineering degree

Tools

Microsoft Office

Job description

Responsibilities

• Provide qualification / validation quality / compliance support compliant with laboratory safety procedures and requirements of Sartorius Stedim
• Perform viability, bacterial challenge, product specific integrity and chemical compatibility tests according to Sartorius standard operating procedures and approved validation protocols
• Perform in-coming material testing
• Prepare strains, culture media, test solutions and reagents necessary for the performance of all laboratory tests
• Handle biological indicators, cultures, chemicals and test solutions according to government regulations and company standard operating procedures
• Complete laboratory data form, interpret results and review
• Inform laboratory manager of any deviations related to validation protocol execution
• Initiate and complete any investigations related to deviation of validation protocols or out of specification results
• Perform necessary cleaning and sanitizing of the laboratory and equipment after testing
• Check daily monitoring data of laboratory environment and temperature controlled equipment
• Perform inventory control of consumables and standard reagents to ensure the safety stock
• Perform qualification, calibration and maintenance of relevant equipment or devices
• Review validation protocols and validation reports
• Assist in maintenance of standard operating procedures, including writing and revising

Qualifications

• Academic or technical degree in sciences / engineering or similar
• Requires a minimum of 3 years of relevant work experience (which can include academic training)
• Experience in the pharmaceutical industry is a plus
• Good understanding of GMP requirements
• Familiar with microbiological analysis testing and operating related equipment
• Self-sufficient, target oriented, well organized and self-motivated work style
• Good communication and problem-solving skills
• Experienced with project management and teamwork (ideally in a global environment)
• Team and customer service orientated attitude
• Proven software skills, e.g. Microsoft Office
• Fluent in English

What we offer

• Paid vacation and sick leave
• 14 paid holidays annually
• Impressive campus: Located on 219,000 square meters, our campus is home for more than 1,000 employees. We offer conference areas, and a development center
• Medical, Dental and Vision insurance along with Company Retirement Plan
• On-site cafeteria and coffee shop
• On-site occupational health offices including Laboratory Services

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex or national origin.

We are also an equal opportunity employer of individuals with disabilities and protected veterans.

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About Sartorius

Sartorius is part of the solution in the fight against cancer, dementia, and many other diseases. Our technologies help translate scientific discoveries into real-world medicine faster, so that new therapeutics can reach patients worldwide. We look for ambitious team players and creative minds, who want to contribute to this goal and advance their careers in a dynamic global environment. Join our global team and become part of the solution.

Information on the application process can also be found in this video and under FAQ & Contact.

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