Quality control analyst jobs in Bayamn, PR

Guaynabo, PR ABOUT US At Triple S, we are committed to provide meaningful job experiences for Valuable People (Gente Valiosa). We encourage an environment of very high ethical standards, always excelling in service, collaboration among the company, agility to deliver timely, and embracing accountability for results. When you join Triple S, you will be key to our efforts on delivering high-quality and affordable healthcare as well as contribute to our purpose to enable healthier lives. We serve more than 1 million consumers in Puerto Rico through our Medicare Advantage, Medicaid, Commercial, Life and Property & Casualty Businesses. Let's build healthier communities together, join now! ABOUT THE ROLE Assists in the planning and direction of the Corporation's efforts to monitor and ensure compliance with internal controls and the NAIC Model Audit Rules across all companies within the Triple-S Management Group. Assists in the development of detailed project plans or initiatives that impact various companies/departments within a division or function and communicates those plans to build support and commitment. Evaluates the design and operation of internal controls over financial reporting and provides feedback to control owner whenever appropriate. Gives follow up and seeks continuous feedback, in order to take action to achieve results. Analyzes complex situations using a systematic approach to identify action plans and contingency plans. Maintains close communication with external auditors and helps in the coordination and the performance of external audit work as it relates to internal controls compliance. Works with other divisions/subsidiaries in other regulatory compliance efforts where internal controls compliance efforts can be leveraged upon. WHAT YOU'LL DO * Select the best methodology to achieve the identified results in a work plan or project. * Prepare reports to be used as reference in operational areas. * Collects and analyzes financial information. * Assist in the planning of the Corporation's internal controls compliance efforts, including risk assessments and the determination of the annual scope of work. Supervise internal controls compliance efforts done by internal/external resources. * Analyze data to detect deficient controls, determine effect in financial statements, and evaluate remediation plans. * Report control deficiencies to management and discuss remediation activities. Examine whether the organization's objectives are reflected in its management activities, and if employees understand the objectives. * Provide accurate and comprehensive status reporting in a timely manner. * Provide timely and accurate assessment of narratives, work papers and other documentation and recommend modifications, as appropriate. * Inquire information, realize research and keep abreast of information related to the requirements of internal controls, Model Audit Rules, the SSAE 18 and any other internal or external regulatory specification. * Develop relationships with parties across the organization to ensure a sustained understanding of internal controls control and Model Audit Rules requirements in areas such as documentation and evidence. * Participate in the training of staff personnel or external resources assisting in internal controls compliance efforts. * Provide guidance to the personnel about controls and responsibilities related and report any changes to internal controls. * Works closely with external evaluating internal controls over financial reporting. * Provide support to TSM subsidiaries with respect to internal controls' analysis. * Communicate results via written reports and/or oral presentations to management. * Ensure that the financial internal controls are implemented as designed and stay updated, resolve any observation related with the internal controls on time. * Provide guidance to your area about the controls and related responsibilities and report to TSM group, in charge of financial internal controls documentation, of any internal control changes. WHAT YOU'LL BRING Bachelor's Degree (BD) in Business Administration with a major in Finance or Accounting with 3 to 5 years preferably in a similar position in the health insurance industry. Or at least 7 years of this experience in lieu of. It is company policy to seek for the qualified applicants for positions throughout the company without distinction of race, color, national origin, religion, sex, gender identity, real or perceived sexual orientation, civil status, social condition, political ideologies, age, physical or mental disability, veteran status or any other characteristic protected by law. Drug-free company. Equality Employment Opportunity/Affirmative Action for People with Disabilities/Veterans". Employer with E-Verify to verify the eligibility of employment of all the new employees. We encourage Veterans and Disabled to Apply

**At Kelly** ** ** **Science, we're passionate about helping you find a job that works for you. How about this one?** We're seeking **Specialist QC** to work for one of our top **Biotechnology Industry client at Juncos, PR** . **Salary: $38.00 p/h** **Requirements:** + PHD or MS degree and 2 years of directly related experience OR BS degree and 4 years of directly related experience OR AD degree and 8 years of directly related experience. Preferable scientific background in Science or Engineering Preferable experience as Microbiologist, Chemist, Biochemistry, Molecular Sciences, or Chemical Engineering + Scientific Data Analysis + Strong Technical Writing (English and Spanish) mainly focuses + Strong knowledge in Microsoft Excel as a Tool for Data Analysis + Knowledge in Computer System and Method Validation (Experience preferable) + Strong knowledge and experience with quality process management + Ability to develop inspection or qualification protocols in a short timeframe period. The **Specialist QC** will be 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 **Kelly** ** ** **Science PR Offers!** + Exposure to a variety of career opportunities as a result of our expansive network of client companies + Career guides, information and tools to help you successfully position yourself throughout every stage of your career + Access to more than 3,000 online training courses through our **Kelly** ** ** **Learning Center** + **Biweekly pay ( W2)** + **Sick, Vacations & Holidays paid*** + **Christmas bonus*** + * Must comply with minimum established requirements to qualify. **APPLY TODAY!** As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here (********************************************************************* for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community. Why Kelly ? As a worker today, it's up to you to take charge of your career and look for opportunities to learn, grow, and achieve your potential. Helping you find what's next is what we're all about. We know what's going on in the evolving world of work-just ask the 440,000 people we employ each year. Connecting with us means getting the support, guidance, and opportunities needed to take your career where you may have never imagined. About Kelly Work changes everything. And at Kelly, we're obsessed with where it can take you. To us, it's about more than simply accepting your next job opportunity. It's the fuel that powers every next step of your life. It's the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life-just ask the 300,000 people we employ each year. Kelly is committed to providing equal employment opportunities to all qualified employees and applicants regardless of race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or any other legally protected status, and we take affirmative action to recruit, employ, and advance qualified individuals with disabilities and protected veterans in the workforce. Requests for accommodation related to our application process can be directed to the Kelly Human Resource Knowledge Center. Kelly complies with the requirements of California's state and local Fair Chance laws. A conviction does not automatically bar individuals from employment. Kelly participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S. Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly's Human Resource Knowledge Center. Kelly complies with the requirements of California's state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.

At TE, you will unleash your potential working with people from diverse backgrounds and industries to create a safer, sustainable and more connected world. Establishes appropriate product design or testing processes; oversees the design or testing processes and associated test equipment. Job Requirements At TE Connectivity, you'll be part of an innovative, fast-paced environment where your contributions directly impact cutting-edge technologies that shape the future. Specifically, the Digital Data Networks Business Unit is seeking a highly skilled and detail-oriented Engineering Designer to join our Advanced Technology team. This role plays a pivotal part in bridging the gap between conceptual design and manufacturable components. Core Responsibilities: Collaborate with Product Development Engineers to refine and finalize part and tool designs. Create detailed, toleranced 3D CAD models using Creo (MBD - Model Based Definition). Generate accurate 2D drawings using AutoCAD. Apply GD&T principles to ensure manufacturability and functional performance. Develop dimensioned drawings for both components and tooling. Ensure designs meet manufacturing capabilities and constraints (stamping, molding, assembly). Support design reviews and receive input on design for manufacturability (DFM). Maintain drawing standards and documentation practices. Assist in troubleshooting design-related issues during prototyping and production phases. What your background should look like Associate or bachelor's degree in mechanical engineering, Design Engineering, or related field. Proven experience in engineering, drafting and design. Proficiency in Creo 3D CAD software; SpaceClaim experience is a plus. Proficiency in AutoCAD 2D CAD software. Strong understanding of GD&T principles and application. Experience designing high-speed, high-density connectors is highly desirable. Knowledge of manufacturing processes including stamping, molding, and assembly. Ability to create dimensioned drawings for both parts and tooling. Excellent attention to detail and organizational skills - can manage multiple tasks simultaneously. Strong communication and collaboration skills - fluent in English. Ability to work in a global environment -capable of collaborating with individuals across geographies. Ability to offer creative solutions to complex problems is a desirable differentiating skill. Competencies Values: Integrity, Accountability, Inclusion, Innovation, Teamwork ABOUT TE CONNECTIVITY TE Connectivity is a global industrial technology leader creating a safer, sustainable, productive, and connected future. Our broad range of connectivity and sensor solutions enable the distribution of power, signal and data to advance next-generation transportation, renewable energy, automated factories, data centers, medical technology and more. With more than 85,000 employees, including 8,000 engineers, working alongside customers in approximately 140 countries. TE ensures that EVERY CONNECTION COUNTS. Learn more at ********** and on LinkedIn, Facebook, WeChat, Instagram and X (formerly Twitter). COMPENSATION • Competitive base salary commensurate with experience: $76,300 - $114,400(subject to change dependent on physical location) • Posted salary ranges are made in good faith. TE Connectivity reserves the right to adjust ranges depending on the experience/qualification of the selected candidate as well as internal and external equity. • Total Compensation = Base Salary + Incentive(s) + Benefits BENEFITS • A comprehensive benefits package including health insurance, 401(k), disability, life insurance, employee stock purchase plan, paid time off and voluntary benefits. EOE, Including Disability/Vets IMPORTANT NOTICE REGARDING RECRUITMENT FRAUD TE Connectivity has become aware of fraudulent recruitment activities being conducted by individuals or organizations falsely claiming to represent TE Connectivity. Please be advised that TE Connectivity never requests payment or fees from job applicants at any stage of the recruitment process. All legitimate job openings are posted exclusively on our official careers website at te.com/careers, and all email communications from our recruitment team will come only from actual email addresses ending **********. If you receive any suspicious communications, we strongly advise you not to engage or provide any personal information, and to report the incident to your local authorities.

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.

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: 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. Responsibilities: * 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. Shift: Administrative Location: Juncos, PR 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 High school/GED + 10 years of directly related experience. 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 Skill: * Understand, support and demonstrate the 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. 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 Companies Affiliated Companies: Echo Consulting Group Inc

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: 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. Responsibilities: * 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. Shift: Administrative Location: Juncos, PR 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 High school/GED + 10 years of directly related experience. 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 Skill: * Understand, support and demonstrate the 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. 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 Companies Affiliated Companies: Echo Consulting Group Inc

The incumbent will perform chemical analysis assuring compliance with regulatory agencies and procedures. Responsibilities Essential Functions & Accountabilities: Trains personnel when necessary. Executes job responsibilities as established in the Standard Operating Procedures. Executes protocols and engineering studies related to laboratory processes. Performs sampling (materials, components, other as required). Performs chemical analysis of materials, components, manufacturing materials, monomers and other applicable test as required. Performs chemical analysis disposition. Assures materials are release on time. Reviews documentation. Challenges equipment performance verification. Execute validation protocols. Generates, evaluates, and investigates nonconformance (NCR's) and assure to close in a timely manner. Complies with good laboratory practices (GLP), QSR, ISO 13485, safety, and environmental regulations. Generates laboratory investigation and assures to close in a timely manner. Performs temperature monitoring, as applicable. Cleans laboratory glassware and equipment used during analysis. Keeps laboratory areas clean and organized. Performs troubleshooting and maintenance to laboratory equipment. Notifies laboratory supplies and equipment inventory needs to perform analysis. Supports other areas as required (e.g., special tests for validations) Verifies periodically the expiration date of materials, components, manufacturing materials, reagents, standards solutions. Coordinates and/or execute laboratory's equipment preventive maintenance. Generates DCO's, ECO's, and Engineer study. Create and revise procedures. Complies and Maintain 6S (ROLESS) in the Laboratory. Non-Essential Functions: Coordinates Lab. daily activities to assure process flow including PM, Cal, and repair. Prepares pronto files. Assists to Lab. Team Leader duties. Quality System Responsibilities Complies with the Quality System Regulation (QSR). Executes job responsibilities as established in the Standard Operating Procedures (SOP). Follows the documentation procedures. Completes training for the qualification and certification, as required, to execute the job. Safety & Occupational Health Responsibilities Complies with Safety and Occupational Health Policy and procedures. Complies with Hazardous Communication program. Notifies immediately all accidents or incidents occurred in work area. Complies with the usage, inspection and maintenance of the personal protective equipment required, if applicable. “We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender, gender identity or expression, or veteran status. We are proud to be an equal opportunity workplace.” Qualifications Qualifications Knowledge, Skills and Abilities: Knowledge in chemistry laboratory instruments and troubleshooting (GC, HPLC, FTIR, UV/VIS, pH, Karl Fischer, etc.) Good skills of sampling techniques, chemical laboratory methods and techniques Good skills in analytical chemistry concepts (i.e., concentration determinations, chemical formulations, etc.) Good technical writing skills Teamwork oriented Good communication skills Initiative and problem-solving skills Able to work overtime, if necessary, with minimum supervision Good oral and written communication skills in both English and Spanish Ability to read, writes, and comprehends instructions in both languages English/Spanish Knowledge of QSR (Quality System Regulations), ISO13485, Good Laboratory Practices, Good Manufacturing Practices, safety, and environmental regulations Computer skills (i.e., Excel, Word, PowerPoint, etc.) Good mathematics skills (i.e., average, rounding rules, multiply, divide, add, subtract, percentage, linear regression, standard deviation, relative standard deviation etc.). Good interpersonal skills at all levels. Highly motivated, self-starter, and responsible person. Demonstrates accuracy and thoroughness. Looks for ways to improve and promote quality. Applies feedback to improve and promote quality. Unexpired Puerto Rico driver's license is required since the position requires to operate pallet jack or finger as usual and integral part of the job. Experience: At least four (4) years of experience in medical devices or pharmaceutical industry and chemical quality laboratory. Demonstrates Initiative and problem-solving skills. Good communication skills. Experience in equipment as HPLC, GC, FTIR, UV/VIS, titrations, pH, others. Experience in HPLC and GC troubleshooting. Education: Bachelor's degree in science with major in Chemistry

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas - immunology, oncology, neuroscience, and eye care - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at *************** Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok (******************************* . Job Description Purpose The QC Lab Supervisor II is responsible for the organization, administration, and supervision of Lab Analysts and other Lab employees; properly overseeing the day-to-day operations by prioritizing shop floor presence. Oversees the processes of the chemical analysis and release of raw materials, in-process, and final products in compliance with current quality criteria while respecting deadlines and managing costs. Ensures effective and efficient utilization of laboratory resources through management of laboratory support activities. The QC Supervisor II is expected to work independently and serve as a mentor to other supervisors. Responsibilities + Responsible for leading and developing a high performing team while prioritizing shop floor presence. This includes hiring, setting performance expectations, providing continuous and on-time performance feedback, coaching staff, assisting in problem-solving, and handling employee matters. Ensures that the department has the appropriate talent and level of performance to meet business objectives. Monitors administration of training, identifies training needs, and ensures development of team. + Oversees the operation and functions of the laboratory group which may include Raw Materials, Finished Products, Projects/validation samples, MEC, and stability samples. Organizes laboratory activity by coordinating the activity of personnel depending on the demands of planning. Controls the products (raw materials, intermediates, and finished products) by following procedures (general, specific, of analysis and use, and qualification of equipment) to meet the lab testing schedule. + Identifies aspects of the tests or results warranting further attention and implements corrective actions. + Reviews and approves Analytical data (may relate to analytical product release depending on regional regulatory requirements). + Supports laboratory investigations, including out-of-specification test results, and ensures effective corrective actions are implemented. + Effectively understands, communicates, and presents QC Metrics. Attends and leads Tier meetings. + Ensures appropriate procedures are in place and that QC activities are executed in line with internal procedures, requirements of cGMP, and relevant safety standards. Identifies improvement opportunities to lab processes and participates in continuous improvement projects. Assesses impact of changes to Laboratory Operations and communicates changes to team. + Assists analysts with analytical/microbial instrumentation. Assures instrumentation availability to achieve schedule and improves capacity by ensuring that preventive and repair maintenance as well as material qualifications are carried out in a timely matter. Plans the needs of instruments by maintaining permanent technical and technological intelligence. Applies systematic corrections and/or corrective actions that mitigate the risk of recurrent instrumentation failures. + Participates in periodic inspection of laboratory facilities to ensure that they are operated and administered according to Good Manufacturing Practices (GMP) and Good Laboratory Practices, maintaining laboratory audit readiness. When required, support supplier, internal, and regulatory audits. + May serve as a backup when the Lab Manager is unavailable. Provides mentorship and guidance to other supervisors who are developing leadership capability. Qualifications Qualifications + Bachelor's Degree required, preferably in a Scientific field (Chemistry, Microbiology, or Biology) + 2+ years of experience supervising a team and at least 2 years of experience working in a QC Lab. + Demonstrated advanced scientific knowledge and technical expertise in chemistry, technical writing, investigations, analytical laboratory equipment, and laboratory operations required. + General knowledge in cGMPs, compendia, and regulations required. + Effective problem-solving, decision-making, teamwork, influence, negotiation, and conflict resolution skills required. + Demonstrated leadership skills and ability to foster an inclusive environment. Ability to effectively train and mentor other supervisors. + Ability to work cross-functionally and coordinate work both within the department and with other departments. + Ability to interpret the impact of laboratory data for appropriate and effective actions. + Ability to identify, develop, communicate, and follow through to completion necessary corrective action plans to resolve problems. *The selected candidate must be available to work on a 1st Shift, Monday to Friday. Additional Information Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: + The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future. + We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees. + This job is eligible to participate in our short-term incentive programs. Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company's sole and absolute discretion, consistent with applicable law. AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. US & Puerto Rico only - to learn more, visit ************************************************************************* US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: *************************************************************

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. "}}],"is Mobile":false,"iframe":"true","job Type":"Full time","apply Name":"Aplicar ahora","zsoid":"6314569","FontFamily":"Arial, Helvetica, sans\-serif","job OtherDetails":[{"field Label":"Industry","uitype":2,"value":"Manufacturing"},{"field Label":"City","uitype":1,"value":"Anasco"},{"field Label":"State\/Province","uitype":1,"value":"Anasco"},{"field Label":"Zip\/Postal Code","uitype":1,"value":"00610"}],"header Name":"QC\/QA Technician","widget Id":"118922000006310086","is JobBoard":"false","user Id":"118922000000026001","attach Arr":[],"custom Template":"1","is CandidateLoginEnabled":true,"job Id":"118922000017022001","FontSize":"15","location":"Anasco","embedsource":"CareerSite","indeed CallBackUrl":"https:\/\/recruit.zoho.com\/recruit\/JBApplyAuth.do","logo Id":"nrt0md43109f3de4c490e9975771d2b120574"}

The incumbent will perform chemical analysis assuring compliance with regulatory agencies and procedures.

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.

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.

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas - immunology, oncology, neuroscience, and eye care - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at *************** Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok. Job Description Purpose The QC Lab Supervisor II is responsible for the organization, administration, and supervision of Lab Analysts and other Lab employees; properly overseeing the day-to-day operations by prioritizing shop floor presence. Oversees the processes of the chemical analysis and release of raw materials, in-process, and final products in compliance with current quality criteria while respecting deadlines and managing costs. Ensures effective and efficient utilization of laboratory resources through management of laboratory support activities. The QC Supervisor II is expected to work independently and serve as a mentor to other supervisors. Responsibilities * Responsible for leading and developing a high performing team while prioritizing shop floor presence. This includes hiring, setting performance expectations, providing continuous and on-time performance feedback, coaching staff, assisting in problem-solving, and handling employee matters. Ensures that the department has the appropriate talent and level of performance to meet business objectives. Monitors administration of training, identifies training needs, and ensures development of team. * Oversees the operation and functions of the laboratory group which may include Raw Materials, Finished Products, Projects/validation samples, MEC, and stability samples. Organizes laboratory activity by coordinating the activity of personnel depending on the demands of planning. Controls the products (raw materials, intermediates, and finished products) by following procedures (general, specific, of analysis and use, and qualification of equipment) to meet the lab testing schedule. * Identifies aspects of the tests or results warranting further attention and implements corrective actions. * Reviews and approves Analytical data (may relate to analytical product release depending on regional regulatory requirements). * Supports laboratory investigations, including out-of-specification test results, and ensures effective corrective actions are implemented. * Effectively understands, communicates, and presents QC Metrics. Attends and leads Tier meetings. * Ensures appropriate procedures are in place and that QC activities are executed in line with internal procedures, requirements of cGMP, and relevant safety standards. Identifies improvement opportunities to lab processes and participates in continuous improvement projects. Assesses impact of changes to Laboratory Operations and communicates changes to team. * Assists analysts with analytical/microbial instrumentation. Assures instrumentation availability to achieve schedule and improves capacity by ensuring that preventive and repair maintenance as well as material qualifications are carried out in a timely matter. Plans the needs of instruments by maintaining permanent technical and technological intelligence. Applies systematic corrections and/or corrective actions that mitigate the risk of recurrent instrumentation failures. * Participates in periodic inspection of laboratory facilities to ensure that they are operated and administered according to Good Manufacturing Practices (GMP) and Good Laboratory Practices, maintaining laboratory audit readiness. When required, support supplier, internal, and regulatory audits. * May serve as a backup when the Lab Manager is unavailable. Provides mentorship and guidance to other supervisors who are developing leadership capability. Qualifications Qualifications * Bachelor's Degree required, preferably in a Scientific field (Chemistry, Microbiology, or Biology) * 2+ years of experience supervising a team and at least 2 years of experience working in a QC Lab. * Demonstrated advanced scientific knowledge and technical expertise in chemistry, technical writing, investigations, analytical laboratory equipment, and laboratory operations required. * General knowledge in cGMPs, compendia, and regulations required. * Effective problem-solving, decision-making, teamwork, influence, negotiation, and conflict resolution skills required. * Demonstrated leadership skills and ability to foster an inclusive environment. Ability to effectively train and mentor other supervisors. * Ability to work cross-functionally and coordinate work both within the department and with other departments. * Ability to interpret the impact of laboratory data for appropriate and effective actions. * Ability to identify, develop, communicate, and follow through to completion necessary corrective action plans to resolve problems. * The selected candidate must be available to work on a 1st Shift, Monday to Friday. Additional Information Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: * The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future. * We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees. * This job is eligible to participate in our short-term incentive programs. Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company's sole and absolute discretion, consistent with applicable law. AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. US & Puerto Rico only - to learn more, visit ************************************************************************* US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: *************************************************************

**Kelly Science & Clinical** is seeking **_Stability Chemist_** for a **contract** position at client in **Naguabo, Puerto Rico.** **Salary: $16.00 per/hour** **Schedule:** 1st shift & 2 nd shift, overtime hours and weekends may be required as necessary _In this role you'll be responsible for Performs chemical and physical analysis to stability products and is involved in the development and validation of analytical procedures following R&D guidelines_ **Responsibilities:** + Perform analytical testing on stability products and samples from other plants. + Assure that test activities are performed in accordance with written procedures + Prepares reports of analytical results. + Maintain informed the progress of test schedules. + Inform the Lab. Manager of supplies needs, standards, and instrument change parts. + Discuss with Lab. Manager of any failure in the analysis results + Manage and handling of hazardous waste in the generation area and coordinate the proper manage to the hazardous waste shed. + Records all analytical result in the analysis forms and laboratory notebooks following specifications, SOP'S and CGMP Guidelines. + Prepares all test solutions to be used in the laboratory, following appropriate specification or analitical procedures. + Maintains Laboratory area in an orderly and clean manner, always following the Current Good Manufacturing Practices (cGMP) and Good Laboratory Practices (cGLP + Performs other specific stability work as assigned by the Lab Manager or designee. + Notifies Lab Manager when errors, incongruities or out specification conditions are observed on documentation and in the analytical data. **Qualifications:** + Bachelor's Degree in Chemistry and at least two years of experience in an analytical laboratory, or equivalent combination of education and experience. + Laboratory equipment: HPLC, GC, UV/VIS, pH meters, IR, RI,Karl Fisher Titrators, analytical balances, scientific calculators and others. + Spanish/English communication skills, both written and verbal. **For this position Kelly** ** ** **Science PR Offers!** + Exposure to a variety of career opportunities as a result of our expansive network of client companies + Career guides, information and tools to help you successfully position yourself throughout every stage of your career + Access to more than 3,000 online training courses through our Kelly Learning Center + Weekly pay + **Sick, Vacations &** **H** **olidays paid *** + **Christmas bonus*** + **_*_** **_Must comply with minimum established requirements to qualify._** **Apply to be a Stability** **_Chemist_** **today! ** **Recruiter: Lilly Abouomar** **\#SETTPuertoRico** As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here (********************************************************************* for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community. Why Kelly Science & Clinical? Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the world's most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goals-it's the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed. About Kelly Work changes everything. And at Kelly, we're obsessed with where it can take you. To us, it's about more than simply accepting your next job opportunity. It's the fuel that powers every next step of your life. It's the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life-just ask the 300,000 people we employ each year. Kelly is committed to providing equal employment opportunities to all qualified employees and applicants regardless of race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or any other legally protected status, and we take affirmative action to recruit, employ, and advance qualified individuals with disabilities and protected veterans in the workforce. Requests for accommodation related to our application process can be directed to the Kelly Human Resource Knowledge Center. Kelly complies with the requirements of California's state and local Fair Chance laws. A conviction does not automatically bar individuals from employment. Kelly participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S. Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly's Human Resource Knowledge Center. Kelly complies with the requirements of California's state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.

The incumbent will perform chemical analysis assuring compliance with regulatory agencies and procedures. Essential Functions & Accountabilities: * Trains personnel when necessary. * Executes job responsibilities as established in the Standard Operating Procedures. * Executes protocols and engineering studies related to laboratory processes. * Performs sampling (materials, components, other as required). * Performs chemical analysis of materials, components, manufacturing materials, monomers and other applicable test as required. * Performs chemical analysis disposition. * Assures materials are release on time. * Reviews documentation. * Challenges equipment performance verification. * Execute validation protocols. * Generates, evaluates, and investigates nonconformance (NCR's) and assure to close in a timely manner. * Complies with good laboratory practices (GLP), QSR, ISO 13485, safety, and environmental regulations. * Generates laboratory investigation and assures to close in a timely manner. * Performs temperature monitoring, as applicable. * Cleans laboratory glassware and equipment used during analysis. Keeps laboratory areas clean and organized. * Performs troubleshooting and maintenance to laboratory equipment. * Notifies laboratory supplies and equipment inventory needs to perform analysis. * Supports other areas as required (e.g., special tests for validations) * Verifies periodically the expiration date of materials, components, manufacturing materials, reagents, standards solutions. * Coordinates and/or execute laboratory's equipment preventive maintenance. * Generates DCO's, ECO's, and Engineer study. * Create and revise procedures. * Complies and Maintain 6S (ROLESS) in the Laboratory. * Non-Essential Functions: * Coordinates Lab. daily activities to assure process flow including PM, Cal, and repair. * Prepares pronto files. * Assists to Lab. Team Leader duties. * Quality System Responsibilities * Complies with the Quality System Regulation (QSR). * Executes job responsibilities as established in the Standard Operating Procedures (SOP). * Follows the documentation procedures. * Completes training for the qualification and certification, as required, to execute the job. * * Safety & Occupational Health Responsibilities * Complies with Safety and Occupational Health Policy and procedures. * Complies with Hazardous Communication program. * Notifies immediately all accidents or incidents occurred in work area. Complies with the usage, inspection and maintenance of the personal protective equipment required, if applicable. "We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender, gender identity or expression, or veteran status. We are proud to be an equal opportunity workplace." Qualifications Knowledge, Skills and Abilities: * Knowledge in chemistry laboratory instruments and troubleshooting (GC, HPLC, FTIR, UV/VIS, pH, Karl Fischer, etc.) * Good skills of sampling techniques, chemical laboratory methods and techniques * Good skills in analytical chemistry concepts (i.e., concentration determinations, chemical formulations, etc.) * Good technical writing skills * Teamwork oriented * Good communication skills * Initiative and problem-solving skills * Able to work overtime, if necessary, with minimum supervision * Good oral and written communication skills in both English and Spanish * Ability to read, writes, and comprehends instructions in both languages English/Spanish * Knowledge of QSR (Quality System Regulations), ISO13485, Good Laboratory Practices, Good Manufacturing Practices, safety, and environmental regulations * Computer skills (i.e., Excel, Word, PowerPoint, etc.) * Good mathematics skills (i.e., average, rounding rules, multiply, divide, add, subtract, percentage, linear regression, standard deviation, relative standard deviation etc.). * Good interpersonal skills at all levels. * Highly motivated, self-starter, and responsible person. * Demonstrates accuracy and thoroughness. * Looks for ways to improve and promote quality. * Applies feedback to improve and promote quality. Unexpired Puerto Rico driver's license is required since the position requires to operate pallet jack or finger as usual and integral part of the job. Experience: * At least four (4) years of experience in medical devices or pharmaceutical industry and chemical quality laboratory. * Demonstrates Initiative and problem-solving skills. Good communication skills. * Experience in equipment as HPLC, GC, FTIR, UV/VIS, titrations, pH, others. Experience in HPLC and GC troubleshooting. Education: Bachelor's degree in science with major in Chemistry

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.

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.

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.

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.