Specialist QA at BioPharma Consulting JAD Group

Juncos, , Puerto Rico -

Full Time

Start Date

Immediate

Expiry Date

24 Jan, 26

Salary

0.0

Posted On

26 Oct, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Project Management, Organizational Skills, Cross-Functional Team Leadership, Stakeholder Influence, Quality Assurance, Manufacturing, Validation, Process Development, Regulatory Compliance, Data Trending, Data Analysis, MS Office, Communication, Facilitation, Presentation Skills, Independent Work

Industry

Biotechnology Research

Description

This position supports the Quality Assurance program by executing a broad range of responsibilities with minimal supervision. The role is ideal for candidates with strong experience in manufacturing quality systems, validation, and regulatory compliance. Key Responsibilities: Review and approve Master Production Records (MPs) Approve process validation protocols and reports Participate in incident triage and approve planned incidents Approve Environmental Characterization reports and sanitary utility system releases Represent QA on New Product Introduction (NPI) teams Lead investigations and site audits Own and manage site quality program procedures Serve as designee for QA Manager on local Change Control Review Board (CCRB) Review risk assessments and support automation, facilities, and environmental programs Review and approve work orders and EMS/BMS alarms Approve non-conformance investigations and CAPA records Approve change controls and authorize lot disposition for shipment Skills: Strong project management and organizational skills Ability to lead cross-functional teams and influence stakeholders Expertise in QA, QAL, manufacturing, validation, and process development Skilled in regulatory interaction and compliance evaluation Advanced data trending and analysis Proficient in MS Office (Word, Excel, PowerPoint, databases) Excellent communication, facilitation, and presentation abilities Ability to work independently and collaborate across all levels Doctorate (PhD) Master’s degree + 2 years of directly related experience Bachelor’s degree + 4 years of directly related experience Associate’s degree + 8 years of directly related experience High School Diploma/GED + 10 years of directly related experience Preferred Qualifications: Experience with New Product Introduction (NPI) Familiarity with Change Control processes Exposure to Factory Acceptance Testing (FATs) Hands-on experience with Validation and Process Performance Qualification (PPQ) 10- months contract with possible extension Administrative Shift

Responsibilities

The Specialist QA will support the Quality Assurance program by reviewing and approving various quality-related documents and participating in incident triage. This role also involves leading investigations, managing site quality program procedures, and representing QA on New Product Introduction teams.