Specialist QA
Juncos, PR · On-site
The Specialist QA performs a wide range of Quality Assurance activities under minimal supervision ... Present EM/CU data at Quality System forums and Management Review meetings. * Ensure facilities ...
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Specialist QA
Juncos, PR · On-site
The Specialist QA performs a wide range of Quality Assurance activities under minimal supervision ... Present EM/CU data at Quality System forums and Management Review meetings. * Ensure facilities ...
PR · On-site
... data quality and integrity, ANDA documentation and other routine QA functions. The QA Specialist is the responsible person for FDA inspections at the site and is listed on the FDA filing and ...
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PR · On-site
... data quality and integrity, ANDA documentation and other routine QA functions. The QA Specialist is the responsible person for FDA inspections at the site and is listed on the FDA filing and ...
Specialist QA
Juncos, PR · On-site
... Quality Assurance program under minimal supervision. FUNCTIONS - Review and approve product MPs ... levels. - Advanced data trending and evaluation. - Ability to evaluate compliance issues ...
Specialist QA
Juncos, PR · On-site
... Quality Assurance program under minimal supervision. FUNCTIONS - Review and approve product MPs ... levels. - Advanced data trending and evaluation. - Ability to evaluate compliance issues ...
... Quality Assurance program under minimal supervision. FUNCTIONS - Review and approve product MPs ... levels. - Advanced data trending and evaluation. - Ability to evaluate compliance issues ...
Quick apply
... Quality Assurance program under minimal supervision. FUNCTIONS - Review and approve product MPs ... levels. - Advanced data trending and evaluation. - Ability to evaluate compliance issues ...
Engage in the Quality Assurance operation in accordance with the QSR, ISO and Ethicon written ... Data Analysis, Process Improvements and Decision Making: * Exercise initiative, leadership and ...
Engage in the Quality Assurance operation in accordance with the QSR, ISO and Ethicon written ... Data Analysis, Process Improvements and Decision Making: * Exercise initiative, leadership and ...
Engage in the Quality Assurance operation in accordance with the QSR, ISO and Ethicon written ... Data Analysis, Process Improvements and Decision Making: * Exercise initiative, leadership and ...
Engage in the Quality Assurance operation in accordance with the QSR, ISO and Ethicon written ... Data Analysis, Process Improvements and Decision Making: * Exercise initiative, leadership and ...
Engage in the Quality Assurance operation in accordance with the QSR, ISO and Ethicon written ... Data Analysis, Process Improvements and Decision Making: * Exercise initiative, leadership and ...
Engage in the Quality Assurance operation in accordance with the QSR, ISO and Ethicon written ... Data Analysis, Process Improvements and Decision Making: * Exercise initiative, leadership and ...
Engage in the Quality Assurance operation in accordance with the QSR, ISO and Ethicon written ... Data Analysis, Process Improvements and Decision Making: * Exercise initiative, leadership and ...
Engage in the Quality Assurance operation in accordance with the QSR, ISO and Ethicon written ... Data Analysis, Process Improvements and Decision Making: * Exercise initiative, leadership and ...
Data trending, analysis, and evaluation * Microbiological testing methods and standards for ... Serve as QA representative on incident triage teams * Approve Environmental Characterization ...
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Data trending, analysis, and evaluation * Microbiological testing methods and standards for ... Serve as QA representative on incident triage teams * Approve Environmental Characterization ...
PR · On-site
Maintain appropriate documentation in compliance with Good Documentation Practices (GDP) and data integrity requirements. Quality Oversight & Compliance Provide Quality Assurance oversight to GMP ...
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PR · On-site
Maintain appropriate documentation in compliance with Good Documentation Practices (GDP) and data integrity requirements. Quality Oversight & Compliance Provide Quality Assurance oversight to GMP ...
Specialist Quality Assurance
Juncos, PR · On-site
For QA Services in the Downstream area. WHAT MAKES YOU A FIT: The Technical Part: * Bachelor ... Data trending, statistical anlaysis, and electronic platforms (Veeva, Spotfire, LIMS, Maximo). The ...
Specialist Quality Assurance
Juncos, PR · On-site
For QA Services in the Downstream area. WHAT MAKES YOU A FIT: The Technical Part: * Bachelor ... Data trending, statistical anlaysis, and electronic platforms (Veeva, Spotfire, LIMS, Maximo). The ...
JT382 - SPECIALIST QA
Juncos, PR · On-site
Bachelor's degree in Microbiology, Biology or Life Sciences * 4+ years of directly related QA ... Data trending and evaluation experience * Microbiological testing methods and standards for clean ...
JT382 - SPECIALIST QA
Juncos, PR · On-site
Bachelor's degree in Microbiology, Biology or Life Sciences * 4+ years of directly related QA ... Data trending and evaluation experience * Microbiological testing methods and standards for clean ...
Specialist QA 35382
Juncos, PR · On-site
Administrative Shift Under minimal supervision, support Quality Assurance program by performing a ... Data trending and evaluation * Microbiological testing methods and standards for clean rooms and ...
Specialist QA 35382
Juncos, PR · On-site
Administrative Shift Under minimal supervision, support Quality Assurance program by performing a ... Data trending and evaluation * Microbiological testing methods and standards for clean rooms and ...
Specialist QA - 35382
Juncos, PR · On-site
Position Summary We are seeking a highly motivated Specialist QA to support Quality Operations ... Key Responsibilities Data Analytics & Trending * Develop, maintain, and continuously improve ...
Specialist QA - 35382
Juncos, PR · On-site
Position Summary We are seeking a highly motivated Specialist QA to support Quality Operations ... Key Responsibilities Data Analytics & Trending * Develop, maintain, and continuously improve ...
Experience in batch record review, audit trail reviews and GDP with focus on data integrity (ALCOA ... of QA operations within the facility, including but not limited to on-the-floor QA support ...
Experience in batch record review, audit trail reviews and GDP with focus on data integrity (ALCOA ... of QA operations within the facility, including but not limited to on-the-floor QA support ...
Experience in batch record review, audit trail reviews and GDP with focus on data integrity (ALCOA ... of QA operations within the facility, including but not limited to on-the-floor QA support ...
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Experience in batch record review, audit trail reviews and GDP with focus on data integrity (ALCOA ... of QA operations within the facility, including but not limited to on-the-floor QA support ...
We help companies connect, protect, analyze, and act on their data and applications wherever they ... Oversee quality assurance processes for hardware modules (e.g., chassis, line cards, ASICs ...
We help companies connect, protect, analyze, and act on their data and applications wherever they ... Oversee quality assurance processes for hardware modules (e.g., chassis, line cards, ASICs ...
We help companies connect, protect, analyze, and act on their data and applications wherever they ... Oversee quality assurance processes for hardware modules (e.g., chassis, line cards, ASICs ...
We help companies connect, protect, analyze, and act on their data and applications wherever they ... Oversee quality assurance processes for hardware modules (e.g., chassis, line cards, ASICs ...
We help companies connect, protect, analyze, and act on their data and applications wherever they ... Oversee quality assurance processes for hardware modules (e.g., chassis, line cards, ASICs ...
We help companies connect, protect, analyze, and act on their data and applications wherever they ... Oversee quality assurance processes for hardware modules (e.g., chassis, line cards, ASICs ...
We help companies connect, protect, analyze, and act on their data and applications wherever they ... Oversee quality assurance processes for hardware modules (e.g., chassis, line cards, ASICs ...
We help companies connect, protect, analyze, and act on their data and applications wherever they ... Oversee quality assurance processes for hardware modules (e.g., chassis, line cards, ASICs ...
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Job description
The Specialist QA performs a wide range of Quality Assurance activities under minimal supervision to support GMP operations. This role is responsible for reviewing, approving, and overseeing quality systems, environmental monitoring programs, investigations, audits, and lot disposition. The Specialist QA serves as a key QA representative across cross‑functional teams, ensuring compliance with cGMP, regulatory expectations, and site quality standards.
Key Responsibilities
- Review and approve product manufacturing procedures (MPs).
- Approve process validation protocols and reports for manufacturing processes.
- Participate in incident triage teams and provide QA oversight.
- Approve Environmental Characterization reports.
- Release sanitary utility systems.
- Approve planned incidents and change controls.
- Represent QA on New Product Introduction (NPI) teams.
- Own and maintain site quality program procedures.
- Serve as QA designee on local CCRB.
- Review and approve Work Orders and EMS/BMS alarms.
- Approve non‑conformance (NC) investigations and CAPA records.
- Provide lot disposition and authorize lots for shipment.
- Lead investigations and support root cause analysis activities.
- Lead site audits and support internal/external inspections.
- Evaluate compliance issues and escalate quality, supply, or safety risks to senior management.
- Support GMP building Environmental Monitoring processes.
- Generate Environmental Monitoring (EM) and Critical Utilities (CU) trend reports.
- Participate or lead Risk Assessments for sampling sites in GMP areas.
- Provide environmental control assessments for change controls, deviations, and audit processes.
- Participate in Environmental Control Network, Aseptic Council, or Contamination Control Network.
- Present EM/CU data at Quality System forums and Management Review meetings.
- Ensure facilities, equipment, materials, processes, and products comply with cGMP and applicable regulations.
Skills
- Strong project management and organizational skills.
- Ability to lead and influence cross‑functional teams.
- Strong knowledge of manufacturing, distribution, QA, validation, and process development.
- Ability to interact effectively with regulatory agencies.
- Strong computer literacy (word processing, presentations, databases, spreadsheets).
- Ability to work independently and collaborate across multiple levels.
- Ability to evaluate compliance issues and recommend corrective actions.
Requirements
Required Education
- Doctorate, OR
- Master’s + 2 years of directly related experience, OR
- Bachelor’s + 4 years of directly related experience, OR
- Associate’s + 8 years of directly related experience, OR
- High School/GED + 10 years of directly related experience
Preferred: Microbiology, Biology, or Life Sciences
Preferred Qualifications
- Environmental Monitoring & Microbial Identification
- Critical Utilities monitoring
- Sampling techniques and equipment
- Data trending, statistical evaluation, and visualization
- Microbiological testing methods for cleanrooms and controlled environments
- Aseptic behavior and contamination control
- Facility cleaning and disinfection practices
- Regulatory standards: Annex 1, FDA Guidance, ISO‑14644‑1, USP
- Software tools: Smartsheets, Microsoft Office, Spotfire, Veeva, LIMS, Maximo
- Fully bilingual (English/Spanish) with strong communication skills
Benefits
- 6-month contract with possible extension
- Administrative shift
About BioPharma Consulting JAD Group
Sourced by ZipRecruiter
Industry
Biotechnology research and development
Company size
51 - 200 Employees
Headquarters location
Cambridge, MA, US
Year founded
2010