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Quality Assurance Biotech Jobs in Puerto Rico (NOW HIRING)

Quality Consulting Group

JT626 - ENGINEER

Juncos, PR · On-site

QUALITY CONSULTING GROUP, a leader in the pharmaceutical, biotech, medical devices, and ... Work with manufacturing, maintenance, process development, utilities, facilities, quality assurance ...

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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:

What job categories do people searching Quality Assurance Biotech jobs in Puerto Rico look for?

The top searched job categories for Quality Assurance Biotech jobs in Puerto Rico are:

Quality Assurance Biotech jobs near you
Infographic showing various Quality Assurance Biotech job openings in Puerto Rico as of August 2026, with employment types broken down into 1% As Needed, 82% Full Time, 13% Part Time, 3% Contract, and 1% Nights. Highlights an 88% Physical, 2% Hybrid, and 10% Remote job distribution.

JT371 - SR QUALITY ENGINEER

Quality Consulting Group

Humacao, PR • On-site

$89K - $120K/yr

Temporary

Posted 12 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:
  • Develops, modifies, applies and maintains quality standards and protocol for processing materials into partially finished or finished materials product.
  • Collaborates with engineering and manufacturing functions to ensure quality standards are in place.
  • Devises and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment.
  • Designs or specifies inspection and testing mechanisms and equipment; conducts quality assurance tests; and performs statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications.
  • Ensures that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements.
  • May specialize in the areas of design, incoming material, production control, product evaluation and reliability, inventory control and/or research and development as they apply to product or process quality.
  • Equipment & Process Validation
  • Quality Systems & Change Control
  • Regulatory Compliance & Manufacturing Change Management

Qualifications:
  • Bachelor's or Master's degree in Mechanical, Industrial, Electrical Engineering, or related field preferred.
  • Experience in FDA/ISO-regulated manufacturing environments, including GMP compliance, inspection readiness, ISO 13485, CAPA, nonconformance management, change control, document control, and risk management.
  • Knowledge of validation and manufacturing processes, including equipment, process, product, and software validation (IQ/OQ/PQ), risk-based validation, and manufacturing controls.
  • Proficiency in problem-solving, risk assessment, and data analysis tools, including FMEA, 5 Whys, Fishbone, SPC, DOE, capability analysis, trending, and process monitoring.
  • Experience with quality and business systems (e.g., Minitab, JMP, Excel, Power BI, SAP) and strong communication, collaboration, continuous improvement, and critical-thinking skills; Lean Six Sigma certification and automation/programming experience are preferred.
  • Availability for 1st shift and 2 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.

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