Manages audit observation, investigations, change control, and CAPAs records in the applicable QMS on timely manner. * Provides technical guidance and quality assurance support in the transfer of new ...
Manages audit observation, investigations, change control, and CAPAs records in the applicable QMS on timely manner. * Provides technical guidance and quality assurance support in the transfer of new ...
Senior Manager Quality Assurance - Major Deviations Lifecycle Team
Juncos, PR · On-site
$150 - $190/hr
Senior Manager Quality Assurance - Major Deviations Lifecycle TeamSkip to main content#Senior Manager Quality Assurance - Major Deviations Lifecycle Team page is loaded## Senior Manager Quality ...
Senior Manager Quality Assurance - Major Deviations Lifecycle Team
Juncos, PR · On-site
$150 - $190/hr
Senior Manager Quality Assurance - Major Deviations Lifecycle TeamSkip to main content#Senior Manager Quality Assurance - Major Deviations Lifecycle Team page is loaded## Senior Manager Quality ...
The Senior Manager partners cross-functionally with Quality Assurance, Quality Control, Manufacturing, Engineering, Supply Chain, Regulatory Affairs and Compliance, Process Development, Environmental ...
The Senior Manager partners cross-functionally with Quality Assurance, Quality Control, Manufacturing, Engineering, Supply Chain, Regulatory Affairs and Compliance, Process Development, Environmental ...
The Senior Manager partners cross-functionally with Quality Assurance, Quality Control, Manufacturing, Engineering, Supply Chain, Regulatory Affairs and Compliance, Process Development, Environmental ...
The Senior Manager partners cross-functionally with Quality Assurance, Quality Control, Manufacturing, Engineering, Supply Chain, Regulatory Affairs and Compliance, Process Development, Environmental ...
Senior Manager Quality Assurance - Major Deviations Lifecycle Team
Juncos, PR · On-site
$130 - $170/hr
The Senior Manager partners cross‑functionally with Quality Assurance, Quality Control, Manufacturing, Engineering, Supply Chain, Regulatory Affairs and Compliance, Process Development ...
Senior Manager Quality Assurance - Major Deviations Lifecycle Team
Juncos, PR · On-site
$130 - $170/hr
The Senior Manager partners cross‑functionally with Quality Assurance, Quality Control, Manufacturing, Engineering, Supply Chain, Regulatory Affairs and Compliance, Process Development ...
JT669 - SPECIALIST QA
Juncos, PR · On-site
$90 - $130/hr
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 ...
JT669 - SPECIALIST QA
Juncos, PR · On-site
$90 - $130/hr
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 ...
Specialist QA
Juncos, PR · On-site
Lead investigations, audits, and support internal/external inspections as part of the audit management team. * Represent QA in New Product Introduction (NPI) activities and provide quality oversight ...
Quick apply
Specialist QA
Juncos, PR · On-site
Lead investigations, audits, and support internal/external inspections as part of the audit management team. * Represent QA in New Product Introduction (NPI) activities and provide quality oversight ...
Specialist QA
Juncos, PR · On-site
COMPETENCIES/SKILLS - Project management skills. - Strong organizational skills, including ability ... QA, QAL, validation and process development. - Demonstrate ability to interact with regulatory ...
Specialist QA
Juncos, PR · On-site
COMPETENCIES/SKILLS - Project management skills. - Strong organizational skills, including ability ... QA, QAL, validation and process development. - Demonstrate ability to interact with regulatory ...
JT670 - SPECIALIST QA
Juncos, PR · On-site
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 ...
JT670 - SPECIALIST QA
Juncos, PR · On-site
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 ...
Specialist QA
Juncos, PR · On-site
$90 - $120/hr
Designee for QA manager on local CCRB. * Review Risk Assessments. * Support Automation activities. * Support facilities and environmental programs. * Review and approve Work Orders. * Review and ...
New
Specialist QA
Juncos, PR · On-site
$90 - $120/hr
Designee for QA manager on local CCRB. * Review Risk Assessments. * Support Automation activities. * Support facilities and environmental programs. * Review and approve Work Orders. * Review and ...
New
Specialist QA - 35615
Juncos, PR · On-site
$65 - $95/hr
... project management involved. Position Summary The Specialist QA is responsible for ensuring ... compliance with quality standards, regulatory requirements, and internal procedures throughout ...
Specialist QA - 35615
Juncos, PR · On-site
$65 - $95/hr
... project management involved. Position Summary The Specialist QA is responsible for ensuring ... compliance with quality standards, regulatory requirements, and internal procedures throughout ...
JT670 - SPECIALIST QA
Juncos, PR · On-site
$90 - $150/hr
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 ...
JT670 - SPECIALIST QA
Juncos, PR · On-site
$90 - $150/hr
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 ...
How about this one? We're seeking an Quality Assurance Analyst to work with one of our top global ... Exception Reporting System, Change Management or Risk Management quality records and programs.
Quick apply
How about this one? We're seeking an Quality Assurance Analyst to work with one of our top global ... Exception Reporting System, Change Management or Risk Management quality records and programs.
QA Specialist
Aguadilla, PR · On-site
$52 - $76/hr
Ensuring product quality and compliance with IMS (Integrated Management System,), ISO 9001 and ... Implement and maintain QA QC procedures and protocols. * SCAR (Supplier Corrective Action Request)
Posted today
QA Specialist
Aguadilla, PR · On-site
$52 - $76/hr
Ensuring product quality and compliance with IMS (Integrated Management System,), ISO 9001 and ... Implement and maintain QA QC procedures and protocols. * SCAR (Supplier Corrective Action Request)
Posted today
This position reports to the Sr. Manager QA Engineering and is part of the Quality Assurance Engineering Team located in Fajardo, Puerto Rico and will be an on-site role. What you will do: Provide ...
This position reports to the Sr. Manager QA Engineering and is part of the Quality Assurance Engineering Team located in Fajardo, Puerto Rico and will be an on-site role. What you will do: Provide ...
This position reports to the Sr. Manager QA Engineering and is part of the Quality Assurance Engineering Team located in Fajardo, Puerto Rico and will be an on-site role. What you will do: * Provide ...
This position reports to the Sr. Manager QA Engineering and is part of the Quality Assurance Engineering Team located in Fajardo, Puerto Rico and will be an on-site role. What you will do: * Provide ...
This position reports to the Sr. Manager QA Engineering and is part of the Quality Assurance Engineering Team located in Fajardo, Puerto Rico and will be an on-site role. What you will do: Provide ...
This position reports to the Sr. Manager QA Engineering and is part of the Quality Assurance Engineering Team located in Fajardo, Puerto Rico and will be an on-site role. What you will do: Provide ...
This position reports to the Sr. Manager QA Engineering and is part of the Quality Assurance Engineering Team located in Fajardo, Puerto Rico and will be an on-site role. What you will do: * Provide ...
This position reports to the Sr. Manager QA Engineering and is part of the Quality Assurance Engineering Team located in Fajardo, Puerto Rico and will be an on-site role. What you will do: * Provide ...
This position reports to the Sr. Manager QA Engineering and is part of the Quality Assurance Engineering Team located in Fajardo, Puerto Rico and will be an on-site role. What you will do: * Provide ...
This position reports to the Sr. Manager QA Engineering and is part of the Quality Assurance Engineering Team located in Fajardo, Puerto Rico and will be an on-site role. What you will do: * Provide ...
This position reports to the Sr. Manager QA Engineering and is part of the Quality Assurance Engineering Team located in Fajardo, Puerto Rico and will be an on-site role. What you will do: * Provide ...
This position reports to the Sr. Manager QA Engineering and is part of the Quality Assurance Engineering Team located in Fajardo, Puerto Rico and will be an on-site role. What you will do: * Provide ...
Manager Quality Assurance information
What are the roles and responsibilities of a Manager Quality Assurance?
What are the key skills and qualifications needed to thrive as a Manager Quality Assurance?
What are some common challenges faced by a Manager Quality Assurance, and how can they be addressed?
Is a quality assurance manager a stressful job?
What do quality assurance managers do?
What does a manager of quality assurance do?
What are the most commonly searched types of Quality Assurance jobs in Puerto Rico?
The most popular types of Quality Assurance jobs in Puerto Rico are:
What are popular job titles related to Manager Quality Assurance jobs in Puerto Rico?
For Manager Quality Assurance jobs in Puerto Rico, the most frequently searched job titles are:
What job categories do people searching Manager Quality Assurance jobs in Puerto Rico look for?
The top searched job categories for Manager Quality Assurance jobs in Puerto Rico are:
What cities in Puerto Rico are hiring for Manager Quality Assurance jobs?
Cities in Puerto Rico with the most Manager Quality Assurance job openings:

Contractor
Re-posted 2 days ago
Job description
WHAT MAKES YOU A FIT:
The Technical Part:
- Bachelor's Degree in Chemical Engineering, Biology, or Microbiology Science & six (6) years of experience in the Pharmaceutical Manufacturing industry.
- Bilingual (English & Spanish)
- Shifts: 2nd shift and as needed.
- 2:00 PM - 10:00 PM
- Work irregular hours, rotating shifts, weekends, and holidays when needed.
- Experience in:
- Area non-sterile Inspection & Packaging
- Audit Inspection & Packaging lines
- Quality Assurance & cGMP Compliance
- GMP Document Approval
- Investigation & Root Cause Analysis
- Cross-Functional Collaboration
The Personality Part:
- Our Next Piece is someone who treats everyone they meet like family, especially our resources, clients, and team members. In other words, being a customer service pro is one of your (many) talents. Being the Piece means you're full of bright ideas and eager to innovate, consistently delivering top-quality results. Are you ready to Be The Piece?
AS A PIECE OF FITS, YOU WILL: (The day-to-day on the job)
- Interfaces directly with manufacturing and/or support areas operations to ensure that appropriate procedures are in place, through the execution of thorough reviews of procedures against practice.
- Leads and participates in the critical review of all documents associated with the manufacturing and/or support areas operations, release, packaging, and relevant activities in the operations areas.
- Ensures that deviations in documentation related to OOS or process parameters outside filing or validation are investigated and resolved by thoroughly reviewing timely corrective actions.
- Provides key technical guidance and oversight to manufacturing and/or support area operations (Sterile, Non-Sterile, QC Laboratories, Warehouse, Engineering, Supply Chain, MS&T, IM, among others) to ensure appropriate cGMPs are in place through quarterly, monthly, weekly, or daily operations audits, as applicable.
- Ensures compliance with all procedures (SOP's) to avoid potential regulatory and compliance issues, including GDP and electronic systems compliance.
- Provides scientific input into investigation management to ensure root causes and CAPAs are aligned with the opportunities identified, enabling a systematic approach.
- Supports actively the investigation processes in manufacturing areas (Sterile and Non Sterile) and support areas such as Warehouse, QC laboratories, IT, MS&T, facilities, and utilities, providing coaching from a quality perspective.
- Provides guidance on gaps identified from the review and actively participates in determining potential remediation activities.
- Supports risk analysis process when required per procedures.
- Evaluates product impact and provides lot disposition recommendations when an investigation is completed as needed.
- Manages audit observation, investigations, change control, and CAPAs records in the applicable QMS on timely manner.
- Provides technical guidance and quality assurance support in the transfer of new products and processes to maintain quality standards.
- Participates in Manufacturing Alignment Teams (MAT) and Project Alignment Teams (PAT), department staff, planning, and change control board meetings, as required.
- Evaluates documentation compliance, including data GDP compliance and electronic system data compliance, and its overall management requirements for all manufacturing and support areas, including QC laboratories, such as CR's, SOP's, BR's, Forms, Logbooks, BOM's, WPP's, qualification and validation Protocols, according to government regulations and clients Policies.
- Provides support to the area QA Leader during the budget preparation activities.
- Evaluates department performance indicators and develops the appropriate corrective actions if needed
- Assists management during internal and regulatory agencies inspections (FDA, DEA, MCA, etc).
- Develops sampling plans based on acceptance quality level criteria when additional or special testing is required.
- Performs trend analysis to provide recommendations in order to improve the process and /or the product quality.
- Supports Media Fill activities to ensure that both typical and atypical interventions are performed as established.
- Supports the Annual Product Review elements for Quality events of manufacturing and environmental monitoring.
- Evaluates and approves the instrumentation and equipment calibration records and critical area engineering drawings.
- Reviews and approves equipment, utilities, and facilities qualification, and system life-cycle documentation.
- Reviews and approves all process, product, and computer systems validation protocols and reports, change control documentation, redressing/reprocessing / rework operations, investigation reports related to manufacturing process and microbiology laboratory, and Annual Product Quality Review (APQRs) elements.
- Approves or rejects procedures impacting drug products, raw material, or packaging components.
- Verifies compliance with clients' policies and Guidelines.
- Participates as quality representative or liaison in site projects
- Performs pre-operational review form approval in the manufacturing and packaging area.
- Performs shop floor walk-through audits and challenges adherence to area procedures, providing coaching and Quality Support in alignment with the business unit to optimize compliance and effectiveness.
- Verifies consistency with other site procedures and/or specifications.
- Reviews and approves investigations related to process, products, utilities, microbiology laboratory, and calibrations.
- Approves Corrective and Preventive actions (CAPAs).
- Approves or rejects specifications impacting drug products, raw material, or packaging components.
- Ensures effective systems for equipment maintenance and calibration, and approves calibration requests.
- Ensures the designation and monitoring of storage conditions for quarantine materials and products.
- Reviews and approves procedures for processes, products, utilities, and laboratories.
- Maintains management informed (via frequent written reports) of any problem that might affect the quality and/or timely release of materials
WHO WE ARE:
We are a Service Provider company different from the rest. We pride ourselves on how we treat the most important piece of our company's puzzle: you! We integrate Engineering, Construction, Maintenance, Utilities, and Specialized Technical services across the Island (and in the US as well!). Our company is flexible, family-oriented, and focused on our resources' well-being, while providing our Pharmaceutical, Medical Device, and Manufacturing industry clients with top-notch quality talent. We're FITS!
Are you the Next Piece?