Manufacturing Specialist/Tablet Press
Quality assurance technician job in Caguas, PR
Mentor Technical Group (MTG) provides a comprehensive portfolio of technical support and solutions for the FDA-regulated industry. As a world leader in life science engineering and technical solutions, MTG has the knowledge and experience to ensure compliance with pharmaceutical, biotechnology, and medical device safety and efficacy guidelines. With offices in Caguas, Puerto Rico, and Boston, United States, we serve life sciences clients in six global markets: United States, Puerto Rico, Dominican Republic, Mexico, Germany, Canada, and South America.
Job Summary: We are seeking a skilled Technical Services Specialist with expertise in tablet press operations to join our team. The ideal candidate will be responsible for ensuring the efficient and effective operation of tablet press machinery, troubleshooting technical issues, and optimizing production processes.
Key Responsibilities:
Operate and maintain tablet press machinery to ensure optimal performance.
Troubleshoot and resolve technical issues related to tablet press operations.
Conduct routine maintenance and calibration of equipment.
Collaborate with the production team to optimize manufacturing processes.
Ensure compliance with safety and quality standards.
Document and report any deviations or issues in the production process.
Provide technical support and training to production staff.
Assist in the development and implementation of process improvements.
Qualifications:
Bachelor's degree in Mechanical Engineering, Pharmaceutical Sciences, or a related field.
Proven experience in tablet press operations and technical services.
Strong understanding of pharmaceutical manufacturing processes.
Excellent problem-solving skills and attention to detail.
Ability to work independently and as part of a team.
Strong communication and interpersonal skills.
Knowledge of GMP (Good Manufacturing Practices) and regulatory requirements.
Mentor Technical Group es un empleador que ofrece igualdad de oportunidades y todos los solicitantes calificados recibirán consideración para el empleo sin importar raza, color, religión, sexo, orientación sexual, identidad de género, información genética, origen nacional, estado de veterano protegido, estado de discapacidad o cualquier otro grupo protegido por ley.
Mentor Technical Group 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.
Auto-ApplyAssoc Config Assurance Administrator
Quality assurance technician job in Juncos, PR
Responsibilities may include the following and other duties may be assigned. Analyzes proposed changes of product design to determine effect on overall product and system. Coordinates modification records for management control. Establishes change orders and prepares for change authorization and documentation by company and subcontractor.
Prepares reports of change effect on overall product.
Reviews and analyzes released engineering change data and coordinates changes with engineering, quality, support, manufacturing, and engineering data control activities.
Ensures that customer requirements are implemented and reviews change accounting activity to ensure compliance with configuration management policies.
SPECIALIST CAREER STREAM: Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects - from design to implementation - while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education.
DIFFERENTIATING FACTORS
Autonomy: Entry-level individual contributor on a project or work team.
Works with close supervision.
Organizational Impact: Delivers work of limited scope, typically smaller, less complex projects or related activities.
Innovation and Complexity: Identifies, defines and addresses problems that are not immediately evident but typically not difficult or complex.
Makes minor changes in systems and processes to solve problems .
Communication and Influence: Communicates primarily with internal contacts within immediate group.
Contacts others to gather, confirm and convey information.
Leadership and Talent Management: N / A - job at this level is focused on self-development .
Required Knowledge and Experience: Requires broad theoretical job knowledge typically obtained through advanced education.
Requires a Baccalaureate degree (or for degrees earned outside of the United States, a degree which satisfies the requirements of 8 C.F.R. § 214.2(h)( 4)(iii)(A), 0 years of experience required.
Specialist QA (Warehouse- Incoming Sampling & Inspection)- 34685
Quality assurance technician job in Juncos, PR
Perform one or more of the following duties and responsibilities in support of Amgen's Quality Assurance program under minimal supervision. Functions: - Review and approve product MPs. - Approve process validation protocols and reports for manufacturing processes.
- Request Quality on incident triage team.
- Approve Environmental Characterization reports.
- Release of sanitary utility systems.
- Approve planned incidents.
- Represent QA on NPI team.
- Lead investigations.
- Lead site audits.
- Own site quality program procedures.
- 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 approve EMS/BMS alarms.
- Approve NC investigations and CAPA records.
- Approve change controls.
- Provide lot disposition and authorize lots for shipment.
Education:
-Masters + 2 years of directly related experience.
-Bachelors + 4 years of directly related experience.
Preferred Qualifications:
Supply Chain; Incoming sampling and inspection; Quality audit of warehouse floor operations; Proficient in Smartsheet, Generative AI, Power BI, SAP; Initiating and approving Quality deviations (non conformances).
Skills:
- Project management skills.
- Strong organizational skills, including ability to follow assignments through to completion.
- Initiate and lead cross functional teams.
- Enhanced skills in leading, influencing and negotiating.
- Strong knowledge in area of expertise.
- Collaborate and coordinate with higher level outside resources.
- Strong knowledge of and experience with processes involved in manufacturing and distribution, QA, QAL, validation and process development.
- Demonstrate ability to interact with regulatory agencies.
- Strong word processing, presentation, database and spreadsheet application skills.
- Strong communication (both written and oral), facilitation and presentation skills.
- Strong skill in working independently and to effectively interact with various levels.
- Advanced data trending and evaluation.
- Ability to evaluate compliance issues.
- Demonstrate the Amgen Values/Leadership Practices.
Work Methodology:
100% On-site
36 months (1st Contract)
3rd (10:00 pm-6:30 am) and Non- Standard Shift (weekends and overtime may also be required).
Professional Service Contract
Quality Support Team Inspector
Quality assurance technician job in Puerto Rico
Quality Support Team Inspector
Organization:
Lufthansa Technik Puerto Rico (LTPR)
Department:
Quality
Responsible to ensure maintenance standards are secured through aircraft close, final, Defect buybacks, and RII inspections. Ensures maintenance standards are improved by identifying and suggesting improvement opportunities
Essential Responsibilities
Ensure progress is made on the aircraft in line with the project network plan and given targets.
Perform close, Final, Defect Buyback, and RII inspections.
Develop an inspection schedule with team leaders, Project Manager, and customer during inspection phase.
Perform surveillance activities using customer's and LTPR's checklists.
Record inspection findings and surveillance activities.
Analyze inspection findings and propose continuous improvement initiatives and training.
Assist or perform Aircraft CRS
Perform in-process inspection on aircraft undergoing repair, overhaul, or alteration to assure compliance with specifications and procedures and with accepted quality standards and practices.
Accomplishes final inspections on aircraft to confirm the completeness of the work done is aligned with manufacturer specification.
Ensure all work Performed by Production or required to be performed have been signed for and no defect exist that would render the aircraft unairworthy
Performed inspection on component changes, test and adjustment on airframe and powerplant systems consistent with good quality practices and to the requirements of the appropriate Aircraft Maintenance Manual
Perform inspection on structural repairs and modifications to ensure compliance to good quality practice and to the requirements of the manufacturer Structural Repair Manual (SRM) or any other approve data.
Performs Surveillance inspections and Spot Check. Document noted discrepancies on company control forms and follow-up to ensure all the noted anomalies have been corrected.
Records/documents discrepancies and conditions or operation malfunctions for correction, adjustment, or repair; evaluates defects and prescribe corrective actions on any discrepancies discovered during inspection.
Complete Service Difficulty Report (SDR) for any major incident
Complete 337 Report for customers and the Federal Aviation Administration (FAA)
Other Responsibilities
Maintains working area clean and organized.
Comply and ensure compliance with company policies, procedures, local and federal regulations.
Perform other tasks and projects, as requested.
Ensure adherence to compliance culture requirements.
Education, Skills, and Competencies
Technical university degree in aviation
A&P Certificate License
Minimum 3 years' experience in commercial aircraft maintenance of which minimum 18 months A320 family experience
A320 family 80-hour General Familiarization course desired
Involvement in aircraft maintenance for at least 6 months in the last two years
Knowledge of FAA regulations
Computer applications experience
Ability to lead and motivate teams and individuals.
Ability to work under pressure and to meet demanding deadlines.
Strong interpersonal and leadership skills
Good communication skills
Excellent organizational skills
Ability to work under pressure and demanding deadlines.
Fluent in English and Spanish (both written and spoken)
This job description reflects management's assignment of essential functions; it does not exclude or restrict the tasks that may be reasonably assigned.
Specialist QA
Quality assurance technician job in Juncos, PR
QRC Group, LLC
is a firm dedicated to offer services to the Pharmaceutical, Medical Devices and Chemical Industries in the validation and regulatory fields.
Log on now to our website ************************ to learn more about our services and solutions!
Job Description
We are seeking a highly skilled and detail-oriented Specialist QA to support supply chain operations within a pharmaceutical environment. This role focuses on ensuring compliance and quality oversight across incoming material inspection, warehouse floor audits, and deviation management. The ideal candidate will bring technical expertise, digital fluency, and a strong understanding of regulated environments.
Primary Focus Areas
• Perform sampling and inspection of incoming materials and components.
• Conduct quality audits of warehouse floor operations to ensure compliance with SOPs and GMP standards.
• Initiate, investigate, and approve quality deviations (non-conformances) in coordination with cross-functional teams.
• Utilize Smartsheet, Power BI, SAP, and Generative AI tools to manage quality data, reporting, and workflows.
Additional Responsibilities
• Review and approve Master Production Records (MPs) and process validation protocols/reports.
• Represent QA on New Product Introduction (NPI) teams and incident triage groups.
• Approve Environmental Characterization reports and release sanitary utility systems.
• Lead investigations and site audits; own site-level quality program procedures.
• Act as designer for QA Manager on local Change Control Review Board (CCRB).
• Review risk assessments, work orders, EMS/BMS alarms, and planned incidents.
• Approve NC investigations, CAPA records, and change controls.
• Provide lot disposition and authorize product lots for shipment.
• Support automation, facilities, and environmental compliance programs.
Qualifications
Education in a relevant scientific or engineering discipline:
-Doctorate or Masters + 2 years of directly related experience or
-Bachelors + 4 years of directly related experience
Shift
- Available for 3rd shit and Non-Standard Shift.
Additional Information
All your information will be kept confidential according to EEO guidelines.
Quality Assurance Specialist
Quality assurance technician job in Toa Baja, PR
Job Details Toa Baja, PR $16.00 - $22.00 Hourly Operational/Non-ERDDescription
Job Title: Quality Assurance Specialist
Company: ARG Ceres JV
ARG Ceres JV, is seeking a detail-oriented and experienced Quality Assurance Specialist to ensure the highest standards of quality and safety in our construction projects. The QA Specialist will be responsible for developing, implementing, and monitoring quality assurance processes to ensure compliance with industry standards, local regulations, and project specifications. This role requires strong technical knowledge, exceptional bilingual communication skills and a commitment to delivering exceptional construction outcomes across residential, commercial, and infrastructure projects.
Key Responsibilities:
Develop and implement quality assurance plans, policies, and procedures tailored to construction projects in Puerto Rico.
Conduct regular inspections and audits of construction sites, materials, and processes to ensure compliance with project specifications, building codes, and Puerto Rico regulations (e.g., Puerto Rico Building Code, OGPe permits).
Identify, document, and address non-conformities, defects, or deviations from quality standards, recommending corrective actions.
Collaborate with project managers, engineers, architects, and subcontractors to ensure quality standards are met throughout all project phases.
Review and verify technical documentation, including blueprints, specifications, and material certifications, for accuracy and compliance.
Monitor and evaluate the performance of construction materials and equipment to ensure durability and safety.
Conduct training sessions for site personnel on quality standards, safety protocols, and best practices.
Prepare detailed reports on quality assurance activities, findings, and corrective measures for internal and client review.
Ensure compliance with environmental regulations and sustainable construction practices specific to Puerto Rico.
Stay updated on industry trends, local regulations, and advancements in construction quality standards.
Qualifications:
Bachelor's degree in Civil Engineering, Construction Management, Architecture, or a related field.
Minimum of 3-5 years of experience in quality assurance or quality control within the construction industry.
In-depth knowledge of Puerto Rico's building codes, permitting processes (OGPe), and local construction regulations.
Familiarity with construction materials, methods, and standards (e.g., ASTM, ACI, OSHA).
Strong analytical and problem-solving skills with a keen eye for detail.
Excellent communication skills in English and Spanish (written and verbal) to interact with diverse teams and stakeholders.
Proficiency in quality management software, MS Office, and construction management tools (e.g., Procore, AutoCAD).
Certification in quality assurance (e.g., ASQ Certified Quality Auditor, ISO 9001) or construction safety (e.g., OSHA 30) is a plus.
Ability to work independently and collaboratively in a fast-paced, deadline-driven environment.
Valid driver's license and willingness to travel to various project sites across Puerto Rico.
Preferred Skills:
Experience with sustainable construction practices and LEED certification processes.
Knowledge of Puerto Rico's unique environmental and seismic considerations in construction.
Ability to manage multiple projects simultaneously while maintaining high-quality standards.
Physical Demands: While performing the duties of this Job, the employee is frequently required to stand; walk; sit; use hands to finger, handle, or feel; reach with hands and arms and talk or hear. The employee must frequently lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus. May vary from site to site and in some cases be greater or lesser than indicated here.
Work Environment: While performing the duties of this Job, the employee is frequently exposed to moving mechanical parts and outside weather conditions. The employee is frequently exposed to wet and/or humid conditions; high, precarious places and vibration. The noise level in the work environment is usually moderate.
ARG Ceres JV is an Equal Opportunity and Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to age, race, color, sex, sexual orientation, gender identity, national origin, religion, disability status, or protected veteran status
MV02-101325 Specialist QA 3rd Shift
Quality assurance technician job in Juncos, PR
Job Description
Validation & Engineering Group, Inc.
(V&EG) is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.
We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:
Specialist QA
2100 to 0530 AST (M - F)
SUMMARY
Perform one or more of the following duties and responsibilities in support of the Quality Assurance program under minimal supervision.
FUNCTIONS
- Review and approve product MPs.
- Approve process validation protocols and reports for manufacturing processes.
- Request Quality on incident triage team.
- Approve Environmental Characterization reports.
- Release of sanitary utility systems.
- Approve planned incidents.
- Represent QA on NPI team.
- Lead investigations.
- Lead site audits.
- Own site quality program procedures.
- 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 approve EMS/BMS alarms.
- Approve NC investigations and CAPA records.
- Approve change controls.
- Provide lot disposition and authorize lots for shipment.
EDUCATION
-Bachelors + 4 years of directly related experience OR
COMPETENCIES/SKILLS
- Project management skills.
- Strong organizational skills, including ability to follow assignments through to completion.
- Initiate and lead cross functional teams.
- Enhanced skills in leading, influencing and negotiating.
- Strong knowledge in area of expertise.
- Collaborate and coordinate with higher level outside resources.
- Strong knowledge of and experience with processes involved in manufacturing and distribution, QA, QAL, validation and process development.
- Demonstrate ability to interact with regulatory agencies.
- Strong word processing, presentation, database and spreadsheet application skills.
- Strong communication (both written and oral), facilitation and presentation skills.
- Strong skill in working independently and to effectively interact with various levels.
- Advanced data trending and evaluation.
- Ability to evaluate compliance issues.
PREFERRED:
Supply Chain
Incoming sampling and inspection
Quality audit of warehouse floor operations
Proficient in Smartsheet, Generative AI, Power BI, SAP
Initiating and approving Quality deviations (nonconformances)
Specialist QA (34685)
Quality assurance technician job in Juncos, PR
Perform one or more of the following duties and responsibilities in support of Quality Assurance program under minimal supervision.
Requirements:
Supply Chain
Incoming sampling and inspection
Quality audit of warehouse floor operations
Proficient in Smartsheet, Generative AI, Power BI, SAP
Initiating and approving Quality deviations (nonconformances)
Responsibilities:
Review and approve product MPs.
Approve process validation protocols and reports for manufacturing processes.
Request Quality on incident triage team.
Approve Environmental Characterization reports.
Release of sanitary utility systems.
Approve planned incidents.
Represent QA on NPI team.
Lead investigations.
Lead site audits.
Own site quality program procedures.
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 approve EMS/BMS alarms.
Approve NC investigations and CAPA records.
Approve change controls.
Provide lot disposition and authorize lots for shipment.
Education:
Doctorate or master's and 2 years of directly related experience; bachelor's and 4 years of directly related experience.
Specialist QA
Quality assurance technician job in Juncos, PR
Our team members are at the heart of everything we do. At Cencora, we are united in our responsibility to create healthier futures, and every person here is essential to us being able to deliver on that purpose. If you want to make a difference at the center of health, come join our innovative company and help us improve the lives of people and animals everywhere. Apply today!
Job Details
Summary of Role:
Perform one or more of the following duties and responsibilities in support of Quality Assurance program under minimal supervision.
Responsibilities:
Review and approve product MPs.
Approve process validation protocols and reports for manufacturing processes.
Request Quality on incident triage team.
Approve Environmental Characterization reports.
Release of sanitary utility systems.
Approve planned incidents.
Represent QA on NPI team.
Lead investigations.
Lead site audits.
Own site quality program procedures.
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 approve EMS/BMS alarms.
Approve NC investigations and CAPA records.
Approve change controls.
Provide lot disposition and authorize lots for shipment.
Shift: 3rd Shift/Non-Standard Shift
Location: Juncos, PR
Education: Doctorate degree or Master's degree and 3 years of directly related experience or Bachelor's degree and 5 years of directly related experience or Associate's degree and 10 years of directly related experience or High school diploma / GED and 12 years of directly related experience.
Preferred Qualifications:
Supply Chain; Incoming sampling and inspection; Quality audit of warehouse floor operations; Proficient in Smartsheet, Generative AI, Power BI, SAP; Initiating and approving Quality deviations (non-conformances)
Skills:
Project management skills.
Strong organizational skills, including ability to follow assignments through to completion.
Initiate and lead cross functional teams.
Enhanced skills in leading, influencing and negotiating.
Strong knowledge in area of expertise.
Collaborate and coordinate with higher level outside resources.
Strong knowledge of and experience with processes involved in manufacturing and distribution, QA, QAL, validation and process development.
Demonstrate ability to interact with regulatory agencies.
Strong word processing, presentation, database and spreadsheet application skills.
Strong communication (both written and oral), facilitation and presentation skills.
Strong skill in working independently and to effectively interact with various levels.
Advanced data trending and evaluation.
Ability to evaluate compliance issues.
Demonstrate the Values/Leadership Practices.
This position is for a fixed term contract supporting one of ECHO Consulting Group (a Cencora company) partners on site at their facility.
What Cencora offers
We provide compensation, benefits, and resources that enable a highly inclusive culture and support our team members' ability to live with purpose every day. In addition to traditional offerings like medical, dental, and vision care, we also provide a comprehensive suite of benefits that focus on the physical, emotional, financial, and social aspects of wellness. This encompasses support for working families, which may include backup dependent care, adoption assistance, infertility coverage, family building support, behavioral health solutions, paid parental leave, and paid caregiver leave. To encourage your personal growth, we also offer a variety of training programs, professional development resources, and opportunities to participate in mentorship programs, employee resource groups, volunteer activities, and much more. For details, visit **************************************
Full time Equal Employment Opportunity
Cencora is committed to providing equal employment opportunity without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, age, disability, veteran status or membership in any other class protected by federal, state or local law.
The company's continued success depends on the full and effective utilization of qualified individuals. Therefore, harassment is prohibited and all matters related to recruiting, training, compensation, benefits, promotions and transfers comply with equal opportunity principles and are non-discriminatory.
Cencora is committed to providing reasonable accommodations to individuals with disabilities during the employment process which are consistent with legal requirements. If you wish to request an accommodation while seeking employment, please call ************ or email ****************. We will make accommodation determinations on a request-by-request basis. Messages and emails regarding anything other than accommodations requests will not be returned
Affiliated CompaniesAffiliated Companies: Echo Consulting Group Inc
Auto-ApplyManufacturing Excellence Specialist
Quality assurance technician job in Catao, PR
The Manufacturing Excellence (ManEx) Specialist at Bacardi is a key driver of operational excellence, responsible for analyzing, optimizing, and sustaining manufacturing processes to deliver improvements in quality, service, productivity, and efficiency. This role supports the implementation of the Bacardi Operating System (BOS), Lean Manufacturing, and Kaizen methodologies, collaborating across all levels and departments to foster a culture of continuous improvement.
RESPONSIBILITIES - WITH OUR CONSUMER AT THE HEART YOUR KEY FOCUS WILL BE
* Process Optimization: Analyze workflows, identify inefficiencies, and implement solutions to reduce waste, improve throughput, and lower costs using data-driven approaches and Lean Six Sigma tools.
* Project Leadership: Lead cross-functional CI projects in partnership with Operations, Quality, Supply Chain, Maintenance, and Engineering.
* Bacardi Operating System (BOS) Implementation: Own BOS pillars for the site, ensuring effective deployment and adherence over time through initiatives such as OGSM, DDS, Kaizen events, Gemba walks, 5S, etc.
* Participates and owns metrics at the corresponding tier level such as Improvement Ideas, Center Lines, Change Overs, Kaizens, etc.
* Training & Coaching: Facilitate Kaizen events, workshops, and training sessions to educate and mentor staff and primos in Lean, Six Sigma, and BOS principles.
* Problem Solving and Root Cause Analysis: Facilitate problem-solving activities for process issues and use structured methods (e.g., 5 Whys, fishbone diagrams) to identify root causes of defects or inefficiencies.
* Performance Monitoring: Establish and track KPIs, analyze data to measure impact, and adjust strategies as needed.
* Documentation & Reporting: Maintain updated applicable SOPs, process maps, and improvement records. Prepare and present progress reports to management and stakeholders.
* System Establishment & Performance Assurance: Develop and implement robust systems and standardized processes to support continuous improvement initiatives across the site. Conduct regular audits and assessments to verify that systems are operating effectively and consistently meet established standards. Utilize feedback loops and performance data to drive ongoing refinement, ensuring sustained compliance and optimal results.
* Quality & Safety Compliance: Ensure all improvements align with Bacardi's safety standards and quality regulations.
* Strategic Alignment: Work with managers and leadership to align CI initiatives with Bacardi's strategic goals.
* SME on efficiency and productivity Computer Monitoring Systems.
SKILLS - THE SKILLS AND EXPERIENCE NEEDED TO CREATE YOUR LEGACY
* Education: Bachelor's degree in Industrial Engineering, Manufacturing Engineering, Operations Management, or related field. Advanced degrees preferred.
* English Level: Intermediate (B1-B2) required; higher proficiency is strongly preferred, especially for presentations and cross-functional communication.
* Microsoft Office Skills: Advanced Excel and PowerPoint are mandatory (data analysis, KPIs, process reporting, effective presentations). Strong proficiency in Outlook and Microsoft Teams is also required.
* Certifications: Lean Six Sigma (Yellow/Green) or equivalent. Familiarity with Kaizen, and BOS methodologies.
* Experience: +5 years in manufacturing operations, with hands-on experience in process improvement, Lean manufacturing, and project management.
* Technical Skills: Proficiency in data analysis, process mapping, and project management. Knowledge of ERP/MES systems is a plus.
* Leadership & Communication: Strong ability to lead teams, influence without authority, and communicate effectively across all organizational levels.
* Analytical & Problem-Solving: Expertise in root cause analysis, statistical process control, and structured problem-solving frameworks.
* Attention to Detail: Detail-oriented with disciplined process documentation and follow-through.
* Data Driven: Decision making and process improvement driven by performance data.
* Demonstrate a positive attitude, strong work ethic and attention to detail, without close supervision.
* Follow all policies/procedures, risk management, safety precautions, rules, regulations, and emergency procedures established at the facility.
* Organize and prioritize work to meet deadlines.
* Work effectively under pressure.
* Work independently, exercising judgment and initiative.
* Must be honest, trustworthy, reliable, dependable and strive to do the best job possible under all circumstances.
* Remain flexible and adjust to situations as they occur.
* Understand and behave in alignment with the Bacardi pillars of Fearless, Founder and Family
LEADERSHIP AGILITY
At Bacardi we care deeply about finding brilliant talent who can bring the following personal attributes to help elevate our 3Fs: Fearless, Family, Founder culture to the next level.
* Belonging: You have a strong capacity to create a culture of 'Belonging', where people feel appreciated for who they are, what they do, and who they can become
* Self-Awareness: You have high levels of self-awareness, are reflective and know yourself well, understanding both your own strengths and weaknesses and your impact on others
* People Agility: You bring a deep ability to understand and relate to people and navigate through tough situations to harness and multiply collective performance
* Results Agility: You demonstrate consistent delivery of results in first-time situations by inspiring teams, exhibiting a presence that builds confidence in yourself and others.
* Mental Agility: You can think critically to penetrate complex problems and expand the possibilities by making fresh connections. You think strategically whilst being execution focused and bring creativity to the challenges you're presented with
* Change Agility: You have a deep natural curiosity, desire to experiment and ability to effectively deal with the heat of change. You have a growth and learning mindset: ready to test, stumble, learn and apply from experience
Disclaimer: Bacardi seeks talent from all backgrounds to bring diversity of thought, agility and capability to our organization across the globe. We promote a working environment where all employees are treated and rewarded fairly. We do not tolerate any form of discrimination that adversely affects individuals or groups on the basis of national origin, race, color, religion, sex, gender, sexual orientation, marital status, disability, age, and any other legally protected aspect of a person's identity.
U.S. applicants have rights under Federal Employment Laws.
Perks of Working for us
At Bacardi, we are committed to providing our Primos (employees) with a comprehensive Total Rewards package of compensation, benefits, incentives, allowances, well-being, and much more to meet the needs of themselves and their families. It goes beyond just Cash! The total rewards program is based on pay for performance, whereby the incentive programs are linked to company and individual performance.
Compensation, Paid Time Off & Retirement:
* Competitive Pay Package
* Competitive Holiday/Paid Time Off, plus additional days offered ( i.e., volunteer day, allowing you to give back to the community)
* Retirement/Pension Plan
Health & Wellbeing
* Medical, Critical Illness, and Life Insurance
* Calm Meditation App subscription (free)
* Employee Assistance Programs
* Best-in-class, family-friendly, and inclusive leave policies
Additional Benefits
The benefits /perks may vary depending on the nature of your employment with Bacardi, your work location, and are subject to change.
Some benefits may be subject to an employee contribution.
Some benefits may be fully or partially subsidized. Incentive plans are linked to the nature of your employment and can vary based on region, market, function or brand.
Auto-ApplyQC/QA Technician
Quality assurance technician job in Aasco, PR
Performs complex tests and analyses to assure that products comply with established specifications. Carries out difficult calculations and prepares documentation that shows the results of tests performed. Completes record of inspection results, acceptance, rejection and disposition. Enters data into log books or computer databases. Compiles data and prepares reports on findings. Conducts scheduled calibration and maintenance on test equipment. Establishes maintenance and calibration schedule for test equipment based on manufacturers' recommendations and maintains equipment records. Coordinates specialized product\/customer quality testing. Prepares custom reports on results. Recommends and implements revisions, corrections and changes to test equipment, procedures and methods. Troubleshoots defective products returned by customers to determine root causes of failure. Compiles data to identify trends and proposes corrective action. Initiates and coordinates discussions with quality, engineering and other relevant departments to develop corrective actions for reoccurring problems.
Requirements Minimum 4 to 6 years of relevant experience in the regulated industry. Bilingual. High school, technical or associate degree completed.
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Specialist QA
Quality assurance technician job in Puerto Rico
Mentor Technical Group (MTG) provides a comprehensive portfolio of technical support and solutions for the FDA-regulated industry. As a world leader in life science engineering and technical solutions, MTG has the knowledge and experience to ensure compliance with pharmaceutical, biotechnology, and medical device safety and efficacy guidelines. With offices in Caguas, Puerto Rico, and Boston, United States, we serve life sciences clients in six global markets: United States, Puerto Rico, Dominican Republic, Mexico, Germany, Canada, and South America.
Responsibilities:
Review and approve product MPs.
Approve process validation protocols and reports for manufacturing processes.
Request Quality on incident triage team.
Approve Environmental Characterization reports.
Release of sanitary utility systems.
Approve planned incidents.
Represent QA on NPI team.
Lead investigations.
Lead site audits.
Own site quality program procedures.
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 approve EMS/BMS alarms.
Approve NC investigations and CAPA records.
Approve change controls.
Provide lot disposition and authorize lots for shipment.
Education:
Ph.D OR MS + 2 years of directly related experience OR BS + 4 years of directly related experience OR Associates + 8 years of directly related experience OR High school/GED + 10 years of directly related experience.
Life Sciences or Engineering
Skills:
Experience performing Quality Oversight
Supporting Supply Chain & Incoming operations experience
Mentor Technical Group es un empleador que ofrece igualdad de oportunidades y todos los solicitantes calificados recibirán consideración para el empleo sin importar raza, color, religión, sexo, orientación sexual, identidad de género, información genética, origen nacional, estado de veterano protegido, estado de discapacidad o cualquier otro grupo protegido por ley.
Mentor Technical Group 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.
Auto-ApplyQuality Technician
Quality assurance technician job in Vega Baja, PR
The Quality Technician will assist in the execution and documentation of quality control activities, focusing on inspection processes, document review, and support for manufacturing area(s). Responsibilities:
Review production documentation per batches.
Assist in the revision of incoming inspection documentation.
Perform quality checks on assembly and inspection lines using established techniques.
Document inspection results and escalate non-conformances.
Maintain compliance with internal procedures and regulatory requirements.
Apply regulatory compliance and quality practices in a regulated manufacturing work environment.
Other assigned duties, as assigned.
Qualifications:
Bachelor´s degree in Science, Administration, Engineering, or related field.
Minimum of 3 years of experience in quality assurance for manufacturing industries.
Familiarity with validation documentation and inspection protocols.
Detail-oriented with strong documentation and communication skills.
Bilingual (English/Spanish) preferred.
Work Methodology:
100% On-site and Full-time project
13 months (1st Contract)
Administrative Shift (if a special validation is required, a second shift may need to be scheduled based on the need).
Professional services contract
Specialist Manufacturing (34600)
Quality assurance technician job in Juncos, PR
Support the execution of manufacturing/quality systems such as non-conformances, process validation, procedures, training, and new product introductions. Apply process, operational, scientific expertise, basic compliance knowledge, and analytical and troubleshooting skills to support manufacturing operations. May serve as primary production process owner for process support systems and assist with process ownership responsibilities on more complex process systems.
Requirements:
Experience writing SOP
Experience in equipment / process
Create new SOP's provide training to manufacturing personnel.
Responsibilities:
Initiate, revise, and approve manufacturing procedures. Ensure all procedures reflect current operations. Serve as a document owner.
Assess process performance by observation of floor operations and review of performance data. Evaluate, plan, and implement solutions for process improvement opportunities.
Provide troubleshooting support.
Assist in generation of training materials and may assist in providing training on scientific or technical aspects of the process.
Support establishment of process monitoring parameters and control limits. Collect process-monitoring data and support the assessment of deviations.
Provide support of timely execution of the process monitoring quarterly reports.
Ensure that all Non-conformances are triaged within the established goal.
Responsible for authoring investigation reports.
Responsible for execution of corrective actions.
Responsible for managing NC/CAPA closure within established goal.
Monitor and communicate incidents trends.
Review equipment/system Root Cause Analysis investigations and support trend evaluations.
Assist with generation of process validation protocols and reports.
Assist with the execution of the process validation.
Support collection and analysis of process validation data.
May participate in regulatory inspections.
Participate in the NPI process to assess requirements for documentation, materials, training, and equipment modifications.
Assess, prioritize, justify, and provide implementation and project management support for process or equipment modification projects.
Assist manufacturing change owner on CCRB packages impacting the process
Participate on the assessment or implementation of special projects or initiatives.
Education:
Doctorate degree or master's degree and 3 years of Manufacturing Operations experience or bachelor's degree and 5 years of Manufacturing Operations experience.
Specialist Manufacturing
Quality assurance technician job in Juncos, PR
Our team members are at the heart of everything we do. At Cencora, we are united in our responsibility to create healthier futures, and every person here is essential to us being able to deliver on that purpose. If you want to make a difference at the center of health, come join our innovative company and help us improve the lives of people and animals everywhere. Apply today!
Job Details
Summary of Role:
With minimal supervision, support the execution of manufacturing/quality systems such as non-conformances, process validation, procedures, training, and new product introductions. Apply process, operational, scientific expertise, basic compliance knowledge, and analytical and troubleshooting skills to support manufacturing operations. May serve as primary production process owner for process support systems and assist with process ownership responsibilities on more complex process systems.
Responsibilities:
Initiate, revise, and approve manufacturing procedures. Ensure all procedures reflect current operations. Serve as a document owner.
Assess process performance by observation of floor operations and review of performance data. Evaluate, plan, and implement solutions for process improvement opportunities.
Assist in generation of training materials and may assist in providing training on scientific or technical aspects of the process.
Support establishment of process monitoring parameters and control limits. Collect process-monitoring data and support the assessment of deviations.
Provide support of timely execution of the process monitoring quarterly reports.
Ensure that all Non-conformances are triaged within the established goal.
Responsible for authoring investigation reports.
Responsible for execution of corrective actions.
Responsible for managing NC/CAPA closure within established goal.
Monitor and communicate incidents trends.
Review equipment/system Root Cause Analysis investigations and support trend evaluations.
Assist with generation of process validation protocols and reports.
Assist with the execution of the process validation.
Support collection and analysis of process validation data.
May participate in regulatory inspections
Participate in the NPI process to assess requirements for documentation, materials, training, and equipment modifications.
Assess, prioritize, justify, and provide implementation and project management support for process or equipment modification projects.
Assist manufacturing change owner on CCRB packages impacting the process.
Participate on the assessment or implementation of special projects or initiatives.
Shift: Administrative
Location: Juncos, PR
Education: Doctorate degree OR Master's degree and 3 years of Manufacturing Operations experience OR Bachelor's degree and 5 years of Manufacturing Operations experience or Associate's degree and 10 years of Manufacturing Operations experience or High school diploma / GED and 12 years of Manufacturing Operations experience.
Academic background in Engineering disciplines, particularly Life Sciences, Engineering, Biotechnology, Chemistry, or a related technical discipline
Preferred Qualifications:
Engineering Experience in Manufacturing Operations - Hands-on experience in process engineering, manufacturing support, or production systems within a regulated environment (biotech, pharmaceutical, or similar).
Technical Knowledge - Familiarity with automation systems, process equipment, and continuous improvement methodologies (Lean Six Sigma, Kaizen, root cause analysis).
Problem-Solving Skills - Demonstrated ability to troubleshoot manufacturing issues, implement corrective/preventive actions (CAPA), and drive process optimization.
Cross-Functional Collaboration - Proven experience working with operations, quality, and maintenance teams to deliver results in a fast-paced environment.
Regulatory / GMP Knowledge - Understanding of cGMP, compliance, and documentation practices for regulated industries.
Additional Strengths - Strong communication, adaptability to change
Skills:
Detailed technical understanding of bioprocessing unit operations.
Skilled in performance of GMP production operations.
Regulatory knowledge and interactions.
Participate and help lead cross-functional teams.
Ability to communicate and collaborate with technical and management staff within manufacturing, process development, and quality.
Organizational, technical writing and presentation skills.
Basic project management skills.
Basic knowledge of control charting.
This position is for a fixed term contract supporting one of ECHO Consulting Group (A Cencora company) partners on site at their facility.
What Cencora offers
We provide compensation, benefits, and resources that enable a highly inclusive culture and support our team members' ability to live with purpose every day. In addition to traditional offerings like medical, dental, and vision care, we also provide a comprehensive suite of benefits that focus on the physical, emotional, financial, and social aspects of wellness. This encompasses support for working families, which may include backup dependent care, adoption assistance, infertility coverage, family building support, behavioral health solutions, paid parental leave, and paid caregiver leave. To encourage your personal growth, we also offer a variety of training programs, professional development resources, and opportunities to participate in mentorship programs, employee resource groups, volunteer activities, and much more. For details, visit **************************************
Full time Equal Employment Opportunity
Cencora is committed to providing equal employment opportunity without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, age, disability, veteran status or membership in any other class protected by federal, state or local law.
The company's continued success depends on the full and effective utilization of qualified individuals. Therefore, harassment is prohibited and all matters related to recruiting, training, compensation, benefits, promotions and transfers comply with equal opportunity principles and are non-discriminatory.
Cencora is committed to providing reasonable accommodations to individuals with disabilities during the employment process which are consistent with legal requirements. If you wish to request an accommodation while seeking employment, please call ************ or email ****************. We will make accommodation determinations on a request-by-request basis. Messages and emails regarding anything other than accommodations requests will not be returned
Affiliated CompaniesAffiliated Companies: Echo Consulting Group Inc
Auto-ApplyQC Lab Equipment Qualification Support
Quality assurance technician job in San Juan, PR
Validation & Engineering Group, Inc. is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, manufacturing operations among other services.
Job Description
Development and execution of Laboratory Equipment Validation. Development of Validation Plan, Risk Assessment, IOQ, CSV IOQ, Traceability Matrix, Validation Report, Operational and Administrative SOPs. Execution of related validation protocols. Development of documentation packages for all activities, including: Original format documents, approved document and applicable drawings.
Qualifications
Bachelor Degree in Chemistry or related discipline
Experience developing Validation Plans, Risk Assessments, IOQ, CSV IOQ, Traceability Matrix, Validation Report, Operational and Administrative SOPs.
Validation Experience in Computer Systems
21 CFR Part 11 practical knowledge
Strong knowledge in GMPs regulations
Technical Writing Experience
Validation expertise in:
Sterilization
Kaye Validator & Data loggers
Process Validation
Equipment Qualification
Re-qualification
Computer System Validation
Additional Information
Positions available for Puerto Rico.
Only candidates that meet the minimum requirements will be considered.
Validation and Engineering Group, Inc. is an Equal Employment Opportunity employer.
Quality Assurance Specialist
Quality assurance technician job in Puerto Rico
Mentor Technical Group (MTG) provides a comprehensive portfolio of technical support and solutions for the FDA-regulated industry. As a world leader in life science engineering and technical solutions, MTG has the knowledge and experience to ensure compliance with pharmaceutical, biotechnology, and medical device safety and efficacy guidelines. With offices in Caguas, Puerto Rico, and Boston and we serve life sciences clients in six global markets: United States, Puerto Rico, Dominican Republic, Mexico, Germany, Canada, and South America.
Responsibilities:
Quality Professional with Manufacturing Process Audit and Batch Record Review experience.
Available for non-standard shifts which include nights and weekends.
Basic knowledge of the process, PASx/MES application, MAXIMO, SAP, and LIMS.
Education & Qualifications
Bachelor's degree and 5 years of directly related experience or Master's degree and 3 years of directly related experience. (Science and Engineering preferred)
Fully Bilingual (Spanish & English)
Available for rotating shifts
Mentor Technical Group es un empleador que ofrece igualdad de oportunidades y todos los solicitantes calificados recibirán consideración para el empleo sin importar raza, color, religión, sexo, orientación sexual, identidad de género, información genética, origen nacional, estado de veterano protegido, estado de discapacidad o cualquier otro grupo protegido por ley.
Mentor Technical Group 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.
Auto-ApplySpecialist Manufacturing
Quality assurance technician job in Juncos, PR
Our team members are at the heart of everything we do. At Cencora, we are united in our responsibility to create healthier futures, and every person here is essential to us being able to deliver on that purpose. If you want to make a difference at the center of health, come join our innovative company and help us improve the lives of people and animals everywhere. Apply today!
Job Details
Summary of Role:
With minimal supervision, support the execution of manufacturing/quality systems such as non-conformances, process validation, procedures, training, and new product introductions. Apply process, operational, scientific expertise, basic compliance knowledge, and analytical and troubleshooting skills to support manufacturing operations. May serve as primary production process owner for process support systems and assist with process ownership responsibilities on more complex process systems.
Responsibilities:
Initiate, revise, and approve manufacturing procedures. Ensure all procedures reflect current operations. Serve as a document owner.
Assess process performance by observation of floor operations and review of performance data. Evaluate, plan, and implement solutions for process improvement opportunities.
Assist in generation of training materials and may assist in providing training on scientific or technical aspects of the process.
Support establishment of process monitoring parameters and control limits. Collect process-monitoring data and support the assessment of deviations.
Provide support of timely execution of the process monitoring quarterly reports.
Ensure that all Non-conformances are triaged within the established goal.
Responsible for authoring investigation reports.
Responsible for execution of corrective actions.
Responsible for managing NC/CAPA closure within established goal.
Monitor and communicate incidents trends.
Review equipment/system Root Cause Analysis investigations and support trend evaluations.
Assist with generation of process validation protocols and reports.
Assist with the execution of the process validation.
Support collection and analysis of process validation data.
May participate in regulatory inspections
Participate in the NPI process to assess requirements for documentation, materials, training, and equipment modifications.
Assess, prioritize, justify, and provide implementation and project management support for process or equipment modification projects.
Assist manufacturing change owner on CCRB packages impacting the process.
Participate on the assessment or implementation of special projects or initiatives.
Shift: Non-Standard Shift / 8hrs shift
Location: Juncos, PR
Education: Doctorate degree OR Master's degree and 3 years of Manufacturing Operations experience OR Bachelor's degree and 5 years of Manufacturing Operations experience or Associate's degree and 10 years of Manufacturing Operations experience or High school diploma / GED and 12 years of Manufacturing Operations experience.
Preferred Qualifications:
Experience writing SOP, experience in equipment / process, create new SOP' and provide training to manufacturing personnel.
Skills:
Detailed technical understanding of bioprocessing unit operations.
Skilled in performance of GMP production operations.
Regulatory knowledge and interactions.
Participate and help lead cross-functional teams.
Ability to communicate and collaborate with technical and management staff within manufacturing, process development, and quality.
Organizational, technical writing and presentation skills.
Basic project management skills.
Basic knowledge of control charting.
This position is for a fixed term contract supporting one of ECHO Consulting Group (A Cencora company) partners on site at their facility.
What Cencora offers
We provide compensation, benefits, and resources that enable a highly inclusive culture and support our team members' ability to live with purpose every day. In addition to traditional offerings like medical, dental, and vision care, we also provide a comprehensive suite of benefits that focus on the physical, emotional, financial, and social aspects of wellness. This encompasses support for working families, which may include backup dependent care, adoption assistance, infertility coverage, family building support, behavioral health solutions, paid parental leave, and paid caregiver leave. To encourage your personal growth, we also offer a variety of training programs, professional development resources, and opportunities to participate in mentorship programs, employee resource groups, volunteer activities, and much more. For details, visit **************************************
Full time Equal Employment Opportunity
Cencora is committed to providing equal employment opportunity without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, age, disability, veteran status or membership in any other class protected by federal, state or local law.
The company's continued success depends on the full and effective utilization of qualified individuals. Therefore, harassment is prohibited and all matters related to recruiting, training, compensation, benefits, promotions and transfers comply with equal opportunity principles and are non-discriminatory.
Cencora is committed to providing reasonable accommodations to individuals with disabilities during the employment process which are consistent with legal requirements. If you wish to request an accommodation while seeking employment, please call ************ or email ****************. We will make accommodation determinations on a request-by-request basis. Messages and emails regarding anything other than accommodations requests will not be returned
Affiliated CompaniesAffiliated Companies: Echo Consulting Group Inc
Auto-ApplySpecialist Quality Control- 34863
Quality assurance technician job in Juncos, PR
Under general direction, functions as the technical specialist for testing and development in areas of molecular biology and microbiology. Focus is on the complex technical issues and scope is typically multi-organizational and/or multi-site and /or involving outside resources.
FUNCTIONS:
Responsible for providing technical guidance, Provide reports, data analysis and ensure flow of communication between technical groups including following up on and resolving issues that arise.
Resolve technical issues and troubleshoot for assays as necessary
Ensure lab compliance which includes: Implementing procedures that enhance GMP, GLP and safety.
Manage existing and/or develop and implement new programs, processes and methodologies.
Develop, revise and audit various complex controlled documents that may have multi-organizational and/or multi-site impact.
Approve lab investigations, Lead audit teams
May serve as subject matter expert to develop technical training.
May perform routine work in a specific area of responsibility as necessary.
Represents the department/organization on various teams, Independently responsible for following through on multi-site action items.
May interact with regulatory agencies regarding area(s) of responsibility including written responses.
May resolve issues with outside resources.
Performs special projects as requested by supervisor, May supervise employees as necessary to meet technical requirements.
REQUIREMENTS:
EDUCATION
High school/GED + 10 years of directly related experience.
Associates + 8 years of directly related experience
Bachelors + 4 years of directly related experience
Masters + 2 years of directly related experience
Preferable Scientific Background (Science or Engineering) with experience in Pharmaceutical Industry, Quality Control, Laboratory Testing, Project Management and Quality processes. Preferable experience as Microbiologist, Chemist, Biochemistry, Molecular Sciences, or Chemical Engineering
PREFERRED QUALIFICATIONS
Scientific Data Analysis
Strong Technical Writing (English and Spanish) mainly focuses.
Strong knowledge in Microsoft Excel as a Tool for Data Analysis.
Good Communication skills
Project Management
Knowledge in Computer System and Method Validation (Experience preferable).
Strong knowledge and experience with quality process management.
Basic Knowledge on equipment preventive maintenance and troubleshooting.
Agile on prioritization of critical tasks.
Ability to develop inspection or qualification protocols in a short timeframe period.
Strong negotiation skills
COMPETENCIES/ SKILLS:
Understand, support and demonstrate the AMGEN values.
Excellent communication skills, facilitation and presentation skills.
Excellent technical writing skills.
Strong computer operation skills including work processing, presentation, database and spreadsheet application skills.
Excellent project management and organizational skills including the ability to independently understand, follow, implement complex instructions and follow assignments through to completion.
Advanced skill in handling multiple responsibilities, tasks and projects simultaneously including ability to shift priorities.
Excellent knowledge of and experience with processes involved in quality analytical labs, validation, manufacturing, quality assurance, process development and distribution.
Extensive knowledge of all testing including the development and validation of assays and the ability to perform all testing in specific area of responsibility.
Knowledge of pharmaceutical processes.
Strong knowledge of U.S. regulations and practices pertaining to the testing of pharmaceutical/biological products.
Knowledge of basic international regulations and practices pertaining to the testing of pharmaceutical/biological products.
Extensive knowledge and application of GMPs/CFRs.
Ability to evaluate compliance issues.
Skill in evaluating and documenting according to Company and various guidelines.
Proficient at maintenance, troubleshooting and operation of equipment in area of expertise.
Advanced scientific data analysis and interpretation skills.
Advanced skills in solving complex problems.
Advanced data trending and evaluation.
Strong skill in working independently and to effectively interact with various levels.
Ability to interact with regulatory agencies both orally and in writing.
Initiate, coordinate and lead cross functional teams.
Excellent skill in leading, motivating, influencing, and negotiating.
WORK METHODOLOGY:
Full on site job in Juncos, PR
Full time job
Expected project duration: 7 months for the first contract
Administrative shift from Monday to Friday
Professional services contract with potential extension based on performance and budget
Expected hiring date: January 2026
MV01-060925 QA Specialist I
Quality assurance technician job in Barceloneta, PR
Validation & Engineering Group, Inc. (V&EG) is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.
We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:
* QA Specialist I
General Position Summary/Purpose:
Purpose:
The QA Technical Services Specialist is responsible for QA batch record review and disposition assuring
that bulk and finished products batch record documentation complies with the policies, regulatory
requirements and current Good Manufacturing Practices. The function ensures the plant products meet
specifications and quality requirements. This will require interaction with other Quality Assurance,
Production, Engineering, IS and Administration personnel. The batch record review encompasses
manufactured batch records, investigation of deviations, exceptions and nonconformance reports.
Responsibilities:
* Audit API and/or finished Drug Product electronic and manual (paper) batch records to assure compliance with applicable GMPs, policies, procedures and guidelines.
* Evaluate potential discrepancies detected in batch records and determine the need for a corrective action. Approve MES exceptions related to production support.
* Track/trend batch record discrepancies per procedural requirements and work with other departments to evaluate the discrepancies to establish necessary actions to reduce errors.
* Give timely disposition to manufactured products in the SAP system based upon result of testing and compliance with Regulatory Agency requirements. Prepare Certificate of Analysis, Certificates of Compliance for API and/or finished Drug Product.
* Enter and verify batch information into the lot restriction management system.
* Assemble the batch record review package and label per the approved retention procedures.
* Prepare reports related to Right the First Time, Release Cycle Time, Regulatory Audit requests and Product Quality Review. Revise procedures as required.
* Coordinate and participate in plant weekly meetings for Shop Floor Control to discuss batch records status including discrepancies and/or issues that may impact batch release.
* Demonstrates accountability and responsibility of EHS performance and compliance.
Qualifications:
* Bachelors Degree in Science preferably in Biology, Chemistry, Biotechnology or Engineering.
* Knowledge and experience in manufacturing of biotechnology products is needed and in aseptic processing is preferable.
* Knowledge of Quality regulations and standards affecting chemical, biological or medical devices (i.e. Quality Systems, FDA regulations, etc.)- 2 years
* Experience working in highly computerized Operations environments.
* Knowledge and experience in SAP, LIMS, MES and biotechnology manufacturing process is necessary. Incumbent must have excellent problem solving, analytical, communication and interpersonal skills (1 year).
* Excellent oral and written communication skills in English and Spanish.
* Minimum 2 years experience.
Daily Work Schedule Expectations Monday to Friday 8-5 / hours arrangements if needed.