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Quality Assurance Biotech Jobs in Puerto Rico (NOW HIRING)

Specialist QA

Juncos, PR · On-site

$90 - $120/hr

... Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory ... Specialist QA FUNCTIONS * Review and approve product MPs. * Approve process validation protocols ...

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... biotechnology & bio-engineering companies within the regulated industry for over 30 years. Since ... We are looking candidates with experience within regulated environment for a SR. Quality Assurance ...

... biotechnology? At Cytiva, one of Danaher's 15+ operating companies, our work saves lives-and we're ... This position reports to the Sr. Manager QA Engineering and is part of the Quality Assurance ...

... biotechnology? At Cytiva, one of Danaher's 15+ operating companies, our work saves lives-and we're ... This position reports to the Sr. Manager QA Engineering and is part of the Quality Assurance ...

... biotechnology? At Cytiva, one of Danaher's 15+ operating companies, our work saves lives-and we're ... This position reports to the Sr. Manager QA Engineering and is part of the Quality Assurance ...

... biotechnology? At Cytiva, one of Danaher's 15+ operating companies, our work saves lives-and we're ... This position reports to the Sr. Manager QA Engineering and is part of the Quality Assurance ...

... biotechnology? At Cytiva, one of Danaher's 15+ operating companies, our work saves lives-and we're ... This position reports to the Sr. Manager QA Engineering and is part of the Quality Assurance ...

... biotechnology? At Cytiva, one of Danaher's 15+ operating companies, our work saves lives-and we're ... This position reports to the Sr. Manager QA Engineering and is part of the Quality Assurance ...

Specialist QA - 35615

Juncos, PR · On-site

$65 - $95/hr

Position Summary The Specialist QA is responsible for ensuring compliance with quality standards ... Experience within the pharmaceutical, biotechnology, medical device, or highly regulated ...

... Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory ... Specialist QA (5:00 pm - 5:30 am) SUMMARY Perform one or more of the following duties and ...

... Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory ... Specialist QA (5:00 pm - 5:30 am) SUMMARY Perform one or more of the following duties and ...

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Quality Assurance Biotech information

What is a quality assurance biotech?

A Quality Assurance (QA) Biotech job involves ensuring that biotechnology products meet regulatory and company standards for safety, efficacy, and quality. QA professionals develop and implement quality systems, conduct audits, review documentation, and ensure compliance with Good Manufacturing Practices (GMP) and other regulations. They collaborate with various departments, including manufacturing, R&D, and regulatory affairs, to maintain product integrity. Their role is critical in preventing defects, ensuring consistent processes, and maintaining compliance with industry standards.

What are the key skills and qualifications needed to thrive in quality assurance biotech?

To thrive as a Quality Assurance Biotech, you need a solid understanding of biotechnology processes, quality control methodologies, and regulatory standards such as GMP, often supported by a degree in biology, chemistry, or a related field. Familiarity with laboratory information management systems (LIMS), documentation software, and industry certifications like ASQ or GMP training is highly beneficial. Attention to detail, strong analytical thinking, and effective communication skills are valued soft skills in this role. These abilities ensure precise compliance with regulatory requirements, facilitate collaboration with cross-functional teams, and help maintain the integrity and safety of biotech products.

What are the most common challenges faced by quality assurance professionals in the biotech industry?

Quality Assurance professionals in biotechnology often encounter challenges related to staying up-to-date with evolving regulatory requirements and ensuring that all processes consistently meet strict quality standards. Additionally, managing thorough documentation and collaborating across various departments—such as research, manufacturing, and regulatory affairs—can be complex. Those in the role may also need to respond quickly to deviations or quality events, requiring both proactive problem-solving and excellent organizational skills. However, overcoming these challenges is highly rewarding, as it directly contributes to maintaining the safety and efficacy of biotech products.

What are the most commonly searched types of Quality Assurance Biotech jobs in Puerto Rico?

The most popular types of Quality Assurance Biotech jobs in Puerto Rico are:

Infographic showing various Quality Assurance Biotech job openings in Puerto Rico as of August 2026, with employment types broken down into 1% As Needed, 81% Full Time, 14% Part Time, 3% Contract, and 1% Nights. Highlights an 91% Physical, 1% Hybrid, and 8% Remote job distribution.

Contractor

Posted 11 days ago


Job description

QUALITY CONSULTING GROUP, a leader in the pharmaceutical, biotech, medical devices, and manufacturing industry, is looking for a talented, highly motivated and enthusiastic to join our team. In this role, you'll work with a highly enthusiastic team, contributing in a world-class manufacturing industry in Puerto Rico & USA.
Responsibilities:
  • Review, approve, and maintain manufacturing process documentation (MPs) in compliance with cGMP requirements
  • Review, approve, and ensure accuracy, completeness, and traceability of GMP documentation, including protocols, reports, investigations, and quality records
  • Approve process validation protocols and reports, including PPQs and cleaning validation documentation
  • Participate as Quality representative on incident triage teams, ensuring timely and compliant decision-making
  • Review and approve planned incidents, deviations, and nonconformances, ensuring appropriate risk assessment and documentation
  • Approve Environmental Characterization and environmental monitoring reports
  • Release and maintain compliance of sanitary utility systems
  • Represent Quality Assurance on New Product Introduction (NPI) teams
  • Lead and document investigations, root cause analyses, and CAPA development
  • Lead and support site audits, including internal, external, and regulatory inspections
  • Own, maintain, and continuously improve site quality program procedures
  • Serve as QA Manager designee on the local Change Control Review Board (CCRB)
  • Review and approve risk assessments and mitigation strategies
  • Support automation systems, including review of validation and change documentation
  • Support facilities, utilities, and environmental compliance programs

Qualifications:
  • Possess a BS in Science, Engineering, Physics, Biology, Chemistry or related fields.
  • Experience in Change Control, Documentation Review, Validation & PPQ
  • Administrative Shift

Quality Consulting Group, LLC is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.