JT845 - SPECIALIST QA
Juncos, PRJobSeen 1w agoSeen in employer's feed 1 day ago
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At a glance
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Requirements
Credentials this posting asks for.
Job overview
Quality Consulting Group seeks a Specialist QA to support pharmaceutical, biotech, medical device, and manufacturing operations in Puerto Rico. The role performs plant-floor quality assurance reviews, supports quality systems and validation activities, assesses compliance and product-quality risks, and partners with cross-functional teams. It also contributes to new product introduction, audits, regulatory inspections, and continuous improvement initiatives.
Skills & qualifications
Skills
Qualifications
Full 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:
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Perform on-the-floor Plant Quality Assurance (PQA) review and approval of cGMP manufacturing processes, procedures, testing methods, documents, and production records.
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Review and approve batch records, MES/EBR, SAP, EDMQ, DQMS, and TrackWise documentation, including deviations, CAPAs, and validations.
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Ensure deviations and quality events are properly triaged, investigated, documented, and resolved in accordance with procedures and cGMP requirements.
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Review and assess changes for potential impact to product quality and compliance.
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Support and oversee CAPA, change control, validation, and other Quality System activities.
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Partner cross-functionally with Manufacturing, Process Development, Validation, Quality Control, Warehouse, Engineering, Facilities, Environmental, and Contractors to ensure compliance with established procedures.
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Provide Quality support for New Product Introduction (NPI) and complex projects.
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Support internal and external audits and regulatory inspections, serving as a Quality representative when required.
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Support commissioning and qualification activities and GxP application validation, including risk assessments and IQ/OQ/PQ documentation.
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Analyze quality data and trends, evaluate compliance issues, and provide recommendations to address quality and operational risks.
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Participate in and lead continuous improvement initiatives and quality projects.
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Communicate quality, compliance, supply, and safety risks to appropriate levels of management.
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Work independently while effectively leading, influencing, and collaborating with cross-functional teams
Qualifications:
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Bachelor's degree in Science or Engineering
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Experience with New Product Introduction (NPI) processes.
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Knowledge of Change Control management and documentation.
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Experience with Factory Acceptance Tests (FATs).
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Knowledge of validation protocols and execution, including equipment and process validation.
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Experience supporting Process Performance Qualification (PPQ) activities.
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Knowledge of Good Manufacturing Practices (GMP) and regulatory requirements.
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Ability to prepare, review, and maintain technical documentation.
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Experience working in a pharmaceutical, biotechnology, or medical device manufacturing environment preferred.
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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.
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How this job compares
Set against the 5,036 open Quality Assurance jobs on Olive Jobs, counted November 6, 2026.
- Pay
- This postingNot listed
- US median$89–143K/yr2,281 salary ranges
- US median$25–31/hr829 hourly ranges
- Openings
- Olive Jobs lists 5,036 open Quality Assurance jobs across the US. 3% of them nationwide are listed as remote or flexible.
- Experience
- Quality Assurance postings that state a minimum ask for 5 years of experience at the median; the middle half ask for 2 to 5 years (3,867 postings).
- Education
- This posting asks for a bachelor's degree; 1,729 of the 5,036 open Quality Assurance jobs (34%) ask for a bachelor's degree or higher.
Counted across the open, public US postings on Olive Jobs on November 6, 2026. Pay medians are the middle values of the low ends and of the high ends of postings that list both ends of a range in the same cadence (a yearly salary or an hourly rate); a range's midpoint is halfway between its ends. Pay and experience figures resting on fewer than 20 postings are left out.
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