Quality control analyst jobs in Dorado, PR - 15 jobs
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LL01-251118 Quality Control Scientist III
Validation & Engineering Group
Quality control analyst job in Imbry, 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:
Quality Control Scientist III
Qualifications:
Bachelor's Degree in Science.
Minimum of 8 years of experience in direct pharmaceutical quality control areas and regulatory operations.
Must be fully bilingual (English / Spanish) with excellent oral skills.
Must be proficient using MS Windows and Microsoft Office applications.
Strong knowledge in cGxP and regulatory guidance as well as understanding of how they are applied to regulatory compliance.
Strong knowledge (according to related area).
Technical Writing skills and investigations processes.
Available to work extended hours, possibility of weekends and holidays.
Responsibilities:
Evaluate compendial changes from the different pharmacopeias.
Generate trend reports of investigations based on the company's procedures.
Evaluate global documents against site-specific procedures and update the site procedure accordingly.
Draft technical documents such as methods, specifications, method validation protocols and reports, method transfer protocols and reports, based on corporate policies, SOPs, compendial guidelines, ICH, DEA, and FDA regulatory guidance.
Generate required change requests for analytical documents and route documents for review and approval.
Conduct laboratory event/out-of-specification/out-of-trend investigations and close them on time.
$60k-71k yearly est. 26d ago
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Specialist Quality Control
Mentor Technical Group 4.7
Quality control analyst 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, PR, Boston, MA & San Francisco, CA and we serve life sciences clients in six global markets: United States, Puerto Rico, Dominican Republic, Mexico, Germany, Canada, and South America.
Responsibilities:
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
Qualifications Requirements/Knowledge/Education/Skills:
Bachelor's Degree in Engineering, Science or Business field and 5 years of 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.
Knowledge in Pharmaceutical and Medical Devices.
PMP Certification Preferred
Fully Bilingual
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.
$57k-67k yearly est. Auto-Apply 60d+ ago
QC Chemistry Scientist (6 openings)
Johnson & Johnson 4.7
Quality control analyst job in Gurabo, PR
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at *******************
Job Function:
Quality
Job Sub Function:
Quality Control
Job Category:
Professional
All Job Posting Locations:
Gurabo, Puerto Rico, United States of America
Job Description:
About Innovative Medicine
Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.
Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.
Learn more at *******************/innovative-medicine
We are searching for the best talent for QC Chemistry Scientist (6 openings) to be located at Gurabo, PR. An internal pre-identified candidate for consideration has been identified. However, all applications will be considered.
The QC Chemistry Scientist is responsible for performing and reviewing all chemical and physical testing of raw materials, products and utilities (i.e. water, etc.) according with internal and compendia specifications. Performs investigations when questionable analytical results have been generated Assures the compliance to all quality control policies, procedures and systems to ensure the timely release of high quality product in support of the supply chain process failure to perform his/her functions effectively could result in product recall.
You will be responsible for:
* Performs all laboratory analysis and activities in accordance with cGMP's practices, internal and external regulations and policies, and consistent with supply chain cycle time goals. Responsible for following laboratory priority report and in-process boards to support manufacturing rhythm wheels and business rules. Complies with all Laboratory Schedules for raw materials and/or drug product testing and special projects. Assures to follow QC initiatives and requirements.
* Verifies (Peer Reviewer) documentation of data generated by other QC Scientist in a timely manner and according to specifications. Assures correctness and informs Supervisors and Managers of any deviation encountered for proper investigation and corrective action plan. Maintains all solutions and samples tested until release of lot for any laboratory investigation required.
* Operates, with the proper training, all laboratory equipment and instrumentation required for testing such as: UV-Visible spectrophotometers, FTIR, pH meters, viscometers, specific gravity apparatus, analytical balances, polarimeters, GC and HPLC chromatographers, dissolution baths and any other computerized system.
* Maintains accurate and neat records of all work performed. Reports results and/or deviations associated in a clear, concise and accurate manner and within the standard time assigned for each material. Limited amount of errors are generated.
* Works on special projects such as equipment calibration, process validation and cleaning and method transfers.
* Complies with the goals of the quality team and with overall business and process goals.
* Maintains the hazardous material storage area in full compliance and optimum housekeeping conditions. Assures all containers and glassware used are properly labeled during usage at all times. Assures proper disposal and reporting to management of any spill deviation encountered related to environmental compliance or safety.
* Actively participates in projects, safety and environmental, GMPs, SOPs trainings and others as required and/or special activities that the company promotes to foster employee involvement and their professional development/growth such as: environmental/safety/GMP improvement project to simplify, reduce, minimize or eliminate environmental or compliance aspects at the job area.
Qualifications / Requirements:
* A minimum of a Bachelor's degree in Chemistry is required.
* A minimum of 1 years of work experience is required.
* Knowledge of cGMP's and compliance.
* Technical knowledge of Chemistry.
* Broader knowledge of basic sample preparation techniques.
* Broader knowledge of analytical techniques such as HPLC, GC, UV-Visible spectrophotometer, Gravimetric, Volumetric, TOC, FTIR, pH meters, Polarimetry.
* Experience working with Wet Chemistry and USP/EP/JP/ChP compendia techniques.
* Computer and Software skills. LIMS system basic knowledge.
* Understand impact of laboratory performance on supply chain and business results.
* Bilingual (English & Spanish).
* Technical writing skills.
* Problem solving/troubleshooting.
* Ability on training colleagues on analytical techniques.
* This position may require availability to work the 1st and/or 2nd shifts, including irregular (non-standard) shifts and/or weekends based on business needs.
Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.
Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via *******************/contact-us/careers , internal employees contact AskGS to be directed to your accommodation resource.
#LI-Onsite
Required Skills:
Preferred Skills:
Analytical Reasoning, Chemical Laboratory, Chemistry, Compliance Management, Continuous Improvement, Controls Compliance, Data Analysis, Execution Focus, Quality Control (QC), Quality Standards, Quality Systems Documentation, Report Writing, Sample Testing, Technical Writing
$56k-68k yearly est. Auto-Apply 3d ago
MV01-120925 Specialist Quality Control
Validation & Engineering Group
Quality control analyst 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 Quality Control
SUMMARY
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.
EDUCATION
Doctorate OR
Masters + 2 years of directly related experience OR
Bachelors + 4 years of directly related experience OR
Associates + 8 years of directly related experience OR
COMPETENCIES/SKILLS
Understand, support and demonstrate the company 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.
$40k-48k yearly est. 7d ago
QC Chemistry Scientist (6 openings)
6120-Janssen Scientific Affairs Legal Entity
Quality control analyst job in Gurabo, PR
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at *******************
Job Function:
Quality
Job Sub Function:
Quality Control
Job Category:
Professional
All Job Posting Locations:
Gurabo, Puerto Rico, United States of America
Job Description:
About Innovative Medicine
Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.
Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.
Learn more at *******************/innovative-medicine
We are searching for the best talent for QC Chemistry Scientist (6 openings) to be located at Gurabo, PR. An internal pre-identified candidate for consideration has been identified. However, all applications will be considered.
The QC Chemistry Scientist is responsible for performing and reviewing all chemical and physical testing of raw materials, products and utilities (i.e. water, etc.) according with internal and compendia specifications. Performs investigations when questionable analytical results have been generated Assures the compliance to all quality control policies, procedures and systems to ensure the timely release of high quality product in support of the supply chain process failure to perform his/her functions effectively could result in product recall.
You will be responsible for:
Performs all laboratory analysis and activities in accordance with cGMP's practices, internal and external regulations and policies, and consistent with supply chain cycle time goals. Responsible for following laboratory priority report and in-process boards to support manufacturing rhythm wheels and business rules. Complies with all Laboratory Schedules for raw materials and/or drug product testing and special projects. Assures to follow QC initiatives and requirements.
Verifies (Peer Reviewer) documentation of data generated by other QC Scientist in a timely manner and according to specifications. Assures correctness and informs Supervisors and Managers of any deviation encountered for proper investigation and corrective action plan. Maintains all solutions and samples tested until release of lot for any laboratory investigation required.
Operates, with the proper training, all laboratory equipment and instrumentation required for testing such as: UV-Visible spectrophotometers, FTIR, pH meters, viscometers, specific gravity apparatus, analytical balances, polarimeters, GC and HPLC chromatographers, dissolution baths and any other computerized system.
Maintains accurate and neat records of all work performed. Reports results and/or deviations associated in a clear, concise and accurate manner and within the standard time assigned for each material. Limited amount of errors are generated.
Works on special projects such as equipment calibration, process validation and cleaning and method transfers.
Complies with the goals of the quality team and with overall business and process goals.
Maintains the hazardous material storage area in full compliance and optimum housekeeping conditions. Assures all containers and glassware used are properly labeled during usage at all times. Assures proper disposal and reporting to management of any spill deviation encountered related to environmental compliance or safety.
Actively participates in projects, safety and environmental, GMPs, SOPs trainings and others as required and/or special activities that the company promotes to foster employee involvement and their professional development/growth such as: environmental/safety/GMP improvement project to simplify, reduce, minimize or eliminate environmental or compliance aspects at the job area.
Qualifications / Requirements:
A minimum of a Bachelor's degree in Chemistry is required.
A minimum of 1 years of work experience is required.
Knowledge of cGMP's and compliance.
Technical knowledge of Chemistry.
Broader knowledge of basic sample preparation techniques.
Broader knowledge of analytical techniques such as HPLC, GC, UV-Visible spectrophotometer, Gravimetric, Volumetric, TOC, FTIR, pH meters, Polarimetry.
Experience working with Wet Chemistry and USP/EP/JP/ChP compendia techniques.
Computer and Software skills. LIMS system basic knowledge.
Understand impact of laboratory performance on supply chain and business results.
Bilingual (English & Spanish).
Technical writing skills.
Problem solving/troubleshooting.
Ability on training colleagues on analytical techniques.
This position may require availability to work the 1st and/or 2nd shifts, including irregular (non-standard) shifts and/or weekends based on business needs.
Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.
Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via *******************/contact-us/careers , internal employees contact AskGS to be directed to your accommodation resource.
#LI-Onsite
Required Skills:
Preferred Skills:
Analytical Reasoning, Chemical Laboratory, Chemistry, Compliance Management, Continuous Improvement, Controls Compliance, Data Analysis, Execution Focus, Quality Control (QC), Quality Standards, Quality Systems Documentation, Report Writing, Sample Testing, Technical Writing
Working with Us Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible.
Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us.
Working with Us
Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.
Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us
Position Summary
Selected employee will be responsible for QC Laboratories Automation of EM Trend Reports. This role requires collaboration with multiple functional areas. The incumbent must comply with all Security Guidelines, Environmental Health and Safety regulations and the current Good Manufacturing Practices required by the Job Function.
Program dates: June 1, 2026 - August 7, 2026.
The hourly compensation for this assignment is $15/hr. Please note that the final individual compensation and any applicable benefits will be determined by your employer of record (and not BMS). Factors influencing this decision may include the characteristics of the assignment, such as demonstrated experience, required skill, and the geographic location of the job. Compensation details are subject to change. This is a temporary, time-bound position intended for the duration of the internship or co-op program. Employment in this role does not imply or guarantee ongoing or permanent employment with BMS.
Key Responsibilities
* Evaluate all site EM trend reports.
* Propose a standardized template for all site EM trend reports.
* Develop an automated tool to build the EM trend reports.
Qualifications & Experience
* Applicants must attend an accredited university in Puerto Rico or reside in Puerto Rico.
* Seniors graduating in Spring or Summer 2026 are eligible to apply only if they will be continuing their education for the following semester (Fall 2026).
* Minimum 2 years of subgraduate studies in Science disciplines such as Biology, Chemistry, Microbiology or Engineering.
* Good knowledge of Personal Computers and computer applications such as Microsoft Office.
* Excellent communications skills (Oral and Written) in English and Spanish.
* Strong interpersonal and teamwork skills; ability to develop and maintain effective professional relations with colleagues at all levels across the organization; ability to integrate actions toward objectives.
If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.
Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as "Transforming patients' lives through science ", every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.
Compensation Overview:
The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee's work schedule, job-related knowledge, and experience. Final, individual compensation will be decided based on demonstrated experience.
Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit *************************************
Benefit offerings are subject to the terms and conditions of the applicable plans in effect at the time and may require enrollment. Our benefits include:
* Health Coverage: Medical, pharmacy, dental, and vision care.
* Wellbeing Support: Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).
* Financial Well-being and Protection: 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support.
Work-life benefits include:
Paid Time Off
* US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees)
* Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees: 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays
Based on eligibility*, additional time off for employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day.
All global employees full and part-time who are actively employed at and paid directly by BMS at the end of the calendar year are eligible to take advantage of the Global Shutdown.
* Eligibility Disclosure: The summer hours program is for United States (U.S.) office-based employees due to the unique nature of their work. Summer hours are generally not available for field sales and manufacturing operations and may also be limited for the capability centers. Employees in remote-by-design or lab-based roles may be eligible for summer hours, depending on the nature of their work, and should discuss eligibility with their manager. Employees covered under a collective bargaining agreement should consult that document to determine if they are eligible. Contractors, leased workers and other service providers are not eligible to participate in the program.
Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as "Transforming patients' lives through science ", every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
On-site Protocol
BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:
Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.
Supporting People with Disabilities
BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to **************************. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.
Candidate Rights
BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: *********************************************
Data Protection
We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at *****************************************
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
If you believe that the job posting is missing information required by local law or incorrect in any way, please contact BMS at ********************. Please provide the Job Title and Requisition number so we can review. Communications related to your application should not be sent to this email and you will not receive a response. Inquiries related to the status of your application should be directed to Chat with Ripley.
R1598117 :
$15 hourly Auto-Apply 10d ago
Quality Control Specialist
Mentor Technical Group 4.7
Quality control analyst 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, PR, Boston, MA & San Francisco, CA and we serve life sciences clients in six global markets: United States, Puerto Rico, Dominican Republic, Mexico, Germany, Canada, and South America.
Responsibilities:
• Laboratory experience in a GMP environment within the Pharmaceutical and/or Biotech industry
• Fully bilingual communications skills (English and Spanish)
• Good communications and presentation skills in English and Spanish
• Project management skills
• Strong organizational skills, including ability to follow assignments through to completion
• Enhanced skills in leading, influencing and negotiating
• Knowledge of and experience with processes involved in manufacturing and distribution, QA, QC, validation and process development
• Basic Knowledge and skills of word processing, presentations, and spreadsheet applications
Qualifications Requirements/Knowledge/Education/Skills:
• Educational background in Chemistry, Microbiology, Biology or Life Sciences
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.
$57k-67k yearly est. Auto-Apply 60d+ ago
QC Chemistry Scientist (6 openings)
8427-Janssen Cilag Manufacturing Legal Entity
Quality control analyst job in Gurabo, PR
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at *******************
Job Function:
Quality
Job Sub Function:
Quality Control
Job Category:
Professional
All Job Posting Locations:
Gurabo, Puerto Rico, United States of America
Job Description:
About Innovative Medicine
Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.
Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.
Learn more at *******************/innovative-medicine
We are searching for the best talent for QC Chemistry Scientist (6 openings) to be located at Gurabo, PR. An internal pre-identified candidate for consideration has been identified. However, all applications will be considered.
The QC Chemistry Scientist is responsible for performing and reviewing all chemical and physical testing of raw materials, products and utilities (i.e. water, etc.) according with internal and compendia specifications. Performs investigations when questionable analytical results have been generated Assures the compliance to all quality control policies, procedures and systems to ensure the timely release of high quality product in support of the supply chain process failure to perform his/her functions effectively could result in product recall.
You will be responsible for:
Performs all laboratory analysis and activities in accordance with cGMP's practices, internal and external regulations and policies, and consistent with supply chain cycle time goals. Responsible for following laboratory priority report and in-process boards to support manufacturing rhythm wheels and business rules. Complies with all Laboratory Schedules for raw materials and/or drug product testing and special projects. Assures to follow QC initiatives and requirements.
Verifies (Peer Reviewer) documentation of data generated by other QC Scientist in a timely manner and according to specifications. Assures correctness and informs Supervisors and Managers of any deviation encountered for proper investigation and corrective action plan. Maintains all solutions and samples tested until release of lot for any laboratory investigation required.
Operates, with the proper training, all laboratory equipment and instrumentation required for testing such as: UV-Visible spectrophotometers, FTIR, pH meters, viscometers, specific gravity apparatus, analytical balances, polarimeters, GC and HPLC chromatographers, dissolution baths and any other computerized system.
Maintains accurate and neat records of all work performed. Reports results and/or deviations associated in a clear, concise and accurate manner and within the standard time assigned for each material. Limited amount of errors are generated.
Works on special projects such as equipment calibration, process validation and cleaning and method transfers.
Complies with the goals of the quality team and with overall business and process goals.
Maintains the hazardous material storage area in full compliance and optimum housekeeping conditions. Assures all containers and glassware used are properly labeled during usage at all times. Assures proper disposal and reporting to management of any spill deviation encountered related to environmental compliance or safety.
Actively participates in projects, safety and environmental, GMPs, SOPs trainings and others as required and/or special activities that the company promotes to foster employee involvement and their professional development/growth such as: environmental/safety/GMP improvement project to simplify, reduce, minimize or eliminate environmental or compliance aspects at the job area.
Qualifications / Requirements:
A minimum of a Bachelor's degree in Chemistry is required.
A minimum of 1 years of work experience is required.
Knowledge of cGMP's and compliance.
Technical knowledge of Chemistry.
Broader knowledge of basic sample preparation techniques.
Broader knowledge of analytical techniques such as HPLC, GC, UV-Visible spectrophotometer, Gravimetric, Volumetric, TOC, FTIR, pH meters, Polarimetry.
Experience working with Wet Chemistry and USP/EP/JP/ChP compendia techniques.
Computer and Software skills. LIMS system basic knowledge.
Understand impact of laboratory performance on supply chain and business results.
Bilingual (English & Spanish).
Technical writing skills.
Problem solving/troubleshooting.
Ability on training colleagues on analytical techniques.
This position may require availability to work the 1st and/or 2nd shifts, including irregular (non-standard) shifts and/or weekends based on business needs.
Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.
Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via *******************/contact-us/careers , internal employees contact AskGS to be directed to your accommodation resource.
#LI-Onsite
Required Skills:
Preferred Skills:
Analytical Reasoning, Chemical Laboratory, Chemistry, Compliance Management, Continuous Improvement, Controls Compliance, Data Analysis, Execution Focus, Quality Control (QC), Quality Standards, Quality Systems Documentation, Report Writing, Sample Testing, Technical Writing
$60k-71k yearly est. Auto-Apply 4d ago
ZL01-120925 - Specialist Quality Control
Validation & Engineering Group
Quality control analyst 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 Quality Control
SUMMARY
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.
EDUCATION
Doctorate OR
Masters + 2 years of directly related experience OR
Bachelors + 4 years of directly related experience OR
COMPETENCIES/SKILLS
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.
ATRIBUTES:
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.
Working with Us Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible.
Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us.
Working with Us
Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.
Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us
Program dates: June 1, 2026 - August 7, 2026.
The hourly compensation for this assignment is $15/hr. Please note that the final individual compensation and any applicable benefits will be determined by your employer of record (and not BMS). Factors influencing this decision may include the characteristics of the assignment, such as demonstrated experience, required skill, and the geographic location of the job. Compensation details are subject to change. This is a temporary, time-bound position intended for the duration of the internship or co-op program. Employment in this role does not imply or guarantee ongoing or permanent employment with BMS.
Position Summary
Selected employee will be responsible for QC Laboratories Equipment calibration and maintenance Program Optimization. This role requires collaboration with multiple functional areas. The incumbent must comply with all Security Guidelines, Environmental Health and Safety regulations and the current Good Manufacturing Practices required by the Job Function.
Key Responsibilities
1) List all QC equipment.
2) Evaluate current equipment Job Plans.
3) Challenge current Job Plans against vendor recommendations and historical performance.
4) Propose and implement identified changes for the improvement of the Equipment calibration and maintenance Program.
Qualifications & Experience
* Applicants must attend an accredited university in Puerto Rico or reside in Puerto Rico.
* Seniors graduating in Spring or Summer 2026 are eligible to apply only if they will be continuing their education for the following semester (Fall 2026).
* Minimum 2 years of subgraduate studies in Science disciplines such as Biology, Chemistry, Microbiology or Engineering.
* Good knowledge of Personal Computers and computer applications such as Microsoft Office.
* Excellent communications skills (Oral and Written) in English and Spanish.
* Strong interpersonal and teamwork skills; ability to develop and maintain effective professional relations with colleagues at all levels across the organization; ability to integrate actions toward objectives.
If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.
Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as "Transforming patients' lives through science ", every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.
Compensation Overview:
The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee's work schedule, job-related knowledge, and experience. Final, individual compensation will be decided based on demonstrated experience.
Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit *************************************
Benefit offerings are subject to the terms and conditions of the applicable plans in effect at the time and may require enrollment. Our benefits include:
* Health Coverage: Medical, pharmacy, dental, and vision care.
* Wellbeing Support: Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).
* Financial Well-being and Protection: 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support.
Work-life benefits include:
Paid Time Off
* US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees)
* Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees: 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays
Based on eligibility*, additional time off for employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day.
All global employees full and part-time who are actively employed at and paid directly by BMS at the end of the calendar year are eligible to take advantage of the Global Shutdown.
* Eligibility Disclosure: The summer hours program is for United States (U.S.) office-based employees due to the unique nature of their work. Summer hours are generally not available for field sales and manufacturing operations and may also be limited for the capability centers. Employees in remote-by-design or lab-based roles may be eligible for summer hours, depending on the nature of their work, and should discuss eligibility with their manager. Employees covered under a collective bargaining agreement should consult that document to determine if they are eligible. Contractors, leased workers and other service providers are not eligible to participate in the program.
Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as "Transforming patients' lives through science ", every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
On-site Protocol
BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:
Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.
Supporting People with Disabilities
BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to **************************. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.
Candidate Rights
BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: *********************************************
Data Protection
We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at *****************************************
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
If you believe that the job posting is missing information required by local law or incorrect in any way, please contact BMS at ********************. Please provide the Job Title and Requisition number so we can review. Communications related to your application should not be sent to this email and you will not receive a response. Inquiries related to the status of your application should be directed to Chat with Ripley.
R1598115 :
$15 hourly Auto-Apply 10d ago
QC Lab Equipment Qualification Support
Validation & Engineering Group
Quality control analyst 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.
$23k-27k yearly est. 60d+ ago
Specialist Quality Control
Mentor Technical Group 4.7
Quality control analyst 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:
Laboratory experience in a GMP environment within the Pharmaceutical and/or Biotech industry
Fully bilingual communications skills (English and Spanish)
Good communications and presentation skills in English and Spanish
Project management skills
Strong organizational skills, including ability to follow assignments through to completion
Enhanced skills in leading, influencing and negotiating
Knowledge of and experience with processes involved in manufacturing and distribution, QA, QC, validation and process development
Basic Knowledge and skills of word processing, presentations, and spreadsheet applications
Qualifications Requirements/Knowledge/Education/Skills:
Ph.D OR MD + 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.
Educational background in Chemistry, Microbiology, Biology or Life Sciences
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.
$57k-67k yearly est. Auto-Apply 60d+ ago
LL01-251118 Quality Control Scientist III
Validation & Engineering Group
Quality control analyst job in Manat, 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:
Quality Control Scientist III
Qualifications:
Bachelor's Degree in Science.
Minimum of 8 years of experience in direct pharmaceutical quality control areas and regulatory operations.
Must be fully bilingual (English / Spanish) with excellent oral skills.
Must be proficient using MS Windows and Microsoft Office applications.
Strong knowledge in cGxP and regulatory guidance as well as understanding of how they are applied to regulatory compliance.
Strong knowledge (according to related area).
Technical Writing skills and investigations processes.
Available to work extended hours, possibility of weekends and holidays.
Responsibilities:
Evaluate compendial changes from the different pharmacopeias.
Generate trend reports of investigations based on the company's procedures.
Evaluate global documents against site-specific procedures and update the site procedure accordingly.
Draft technical documents such as methods, specifications, method validation protocols and reports, method transfer protocols and reports, based on corporate policies, SOPs, compendial guidelines, ICH, DEA, and FDA regulatory guidance.
Generate required change requests for analytical documents and route documents for review and approval.
Conduct laboratory event/out-of-specification/out-of-trend investigations and close them on time.
$60k-71k yearly est. 26d ago
Quality Control Scientist, Laboratory Chemist
Validation & Engineering Group
Quality control analyst job in Juncos, PR
Validation & Engineering Group (V&EG) is a leading services supplier 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.
Job Description
Under general direction, functions as the technical specialist for testing & 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.
Competencies/Skills: Understand, support and demonstrate 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
Qualifications
Expertise in Technical Writing, must have written reports for investigations, method transfers/validations,
• Root Cause Analysis experience and CAPA identification and implementation
• Fully bilingual English/Spanish
• Meeting and conference calls facilitator, with multilevel audience (Upper level Management to analysts)
• Presentation skills
• Oriented to solve problems and troubleshoot, technical proficiency
• Simple statistical assessments
Doctorate degree in Sciences or Master's degree in Sciences & 3 years of directly related experience or Bachelor's degree in Sciences & 5 years of directly related experience
• BS in Chemistry or Biochemistry preferred
• Knowledge in TrackWise, CDOCS, Maximo
• Knowledge in PowerPoint, Excel, Word, One Note
Additional Information
Positions available for Puerto Rico.
Validation and Engineering Group, Inc. is an Equal Employment Opportunity employer.
$60k-71k yearly est. 60d+ ago
QC Analyst
Validation & Engineering Group
Quality control analyst job in Manat, PR
Validation & Engineering Group (VEG) is a leading services supplier 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.
Job Description
Responsible for performing chemical and physical testing and analysis in accordance with prescribed methods, procedures and regulations. Performs a variety of duties related to the efficient and effective functioning of the laboratory.
Performs chemical and physical testing and analysis to raw materials, in-process product, validation samples, special samples, finished goods, and stabilities in accordance with prescribed methods, procedures and regulations.
Reports any deviation or suspect result immediately to the laboratory supervisor and collaborates to identify the root cause.
Accurately and timely captures and document data. Promptly enters data into respective system. Maintains detailed records in compliance with applicable procedures.
Reviews laboratory data for validity and accuracy. Reports any non conformances.
Executes validation protocols and documents results.
Troubleshoots and maintains laboratory equipment and instruments.
Assists with Change Controls.
Maintains laboratory supplies and assures adequate inventory.
Qualifications
Bachelor Degree in Sciences, preferred in Chemistry or Biochemistry
Active license preferred,(based on professional experience for the job, Chemical Technology, Biology, Microbiology, and Medical Technology may be considered).
This position requires one year of relevant experience in laboratory.
Additional Information
Positions available for Puerto Rico.
Validation and Engineering Group, Inc. is an Equal Employment Opportunity employer.
How much does a quality control analyst earn in Dorado, PR?
The average quality control analyst in Dorado, PR earns between $40,000 and $58,000 annually. This compares to the national average quality control analyst range of $40,000 to $86,000.
Average quality control analyst salary in Dorado, PR