Quality Control Associate jobs at Bristol-Myers Squibb

Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas! Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at **************** . **Astellas Institute for Regenerative Medicine (AIRM)** is a wholly owned subsidiary of Astellas Pharma Inc and focused on the development and commercialization of stem cell and regenerative medicine therapies. Astellas is an R&D-driven global pharmaceutical company whose philosophy is to contribute to the improvement of people's health around the world through the provision of innovative and reliable pharmaceutical products. AIRM has a world-class R&D team, and is pursuing a diverse range of disease indications, ranging from macular degeneration (currently in clinical trials) and other ocular indications to vascular and autoimmune disease. AIRM's intellectual property portfolio includes pluripotent stem cell platforms -- both embryonic and induced pluripotent stem cells as well as other cell-based therapy research programs. AIRM is headquartered in Massachusetts. Astellas is announcing a **QC Scientist I Raw Materials** opportunity at their **Astellas Institute for Regenerative Medicine (AIRM)** site in **Westborough, MA.** **Purpose:** The QC Scientist I Raw Materials will be responsible for executing and troubleshooting a variety of laboratory test methods, defining the requirements for implementation of procedures, processes and assays within QC, and identifying and implementing continuous improvement initiatives related to overall laboratory functionality. This role will work closely with the assay transfer technical lead. This role will mentor junior analysts and develop and facilitate training initiatives within the labs. **Essential Job Responsibilities:** + Develop/author/revise technical reports and laboratory procedures (SOPs, methods) + Execute and troubleshoot raw material testing in support of production activities + Perform routine release sampling and managing testing of raw materials, such as compendial analysis per USP, Ph.Eur., and JP monographs and general chapters, based on cGMP and internal procedures + Design and perform testing in support of method transfer/validation/qualification/verification + Review/authorize data and perform analysis and interpretation of test results and trends + Design and/or participate in method development; equipment qualification/validation studies; deviation and OOS investigations + Perform QC lab support activities including but not limited to sample management, reagent preparation, instrumentation maintenance, and instrument calibration + Support and mentor junior team members + Collaborate with other network sites to share best practices + Other duties as required **Quantitative Dimensions:** The QC Scientist I Raw Materials will be accountable for executing and troubleshooting a variety of laboratory test methods, defining the requirements for implementation of procedures, processes and assays within QC, and identifying and implementing continuous improvement initiatives related to overall laboratory functionality. **Organizational Context:** The QC Scientist I Raw Materials will typically report to the Senior Manager, Quality Control Raw Materials. This role is expected to Model our Core Values and to demonstrate work performance as someone who exemplifies the culture we want to create; operates with transparency; is trusted; and supports the overall mission and vision of Astellas Gene Therapies and the Astellas organization **Qualifications** **Required:** + B.S. degree in chemistry, biological sciences or related field with 6+ years or M.S. degree with 4+ years of relevant experience in a GMP Quality Control role + Prior laboratory hands-on experience with a variety of techniques such as FTIR, Raman, Near-IR, HPLC analysis and other compendial assays + Technical knowledge and experience in relevant areas of 21CFR, ICH, USP, Ph. Eur. and FDA guidance documents as well as cGXPs in support of clinical and commercial manufacturing + Proven knowledge in cGMP raw material program (RM sampling plans and testing requirements) + Ensures inspection, testing and release timelines are met. + Strong understanding of data integrity requirements and regulatory requirements pertaining to biotechnology and pharmaceutical industries and proven experience analyzing experimental data + Experience using LIMS as an end user; Excellent technical writing and verbal communication skills + Must be capable of observing and adhering to lab safety standards and procedures + Successfully performs work independently with minimal instructions + Strong interpersonal skills, highly collaborative within a multi-discipline team and contributes to a supportive and positive work environment, strong knowledge of GMP, SOPs and quality control processes, and strong knowledge of quality systems and regulatory requirements + Excels in a fast-paced team environment, handles multiple tasks concurrently, and in a timely fashion + Highly self-motivated and goal oriented + Will support and demonstrate quality standards to ensure data of highest quality and works closely with team and other functional key stakeholders on the Astellas Operations team to execute work and will be expected to perform other duties and/or special projects as assigned **Preferred:** + Experience in a Biotech/Pharmaceutical company with a high growth, fast-paced environment + Experience in qualification of analytical equipment, including those with computerized systems + Experience in method validation/qualification/verification/transfer **Working Conditions:** + This role frequently requires long periods of sitting, standing and use of hands and regular motion to include bending, stooping, and lifting up to 20lbs. + This is an on-site role working in a cGMP regulated manufacturing facility. **Salary Range** : $91,000-$143,000 (Final compensation will be determined based on a variety of factors, including but not limited to skills, experience and organizational equity considerations) **Benefits** : + Medical, Dental and Vision Insurance + Generous Paid Time Off options, including Vacation and Sick time, plus national holidays including year-end shut down + 401(k) match and annual company contribution + Company paid life insurance + Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions + Long Term Incentive Plan for eligible positions + Company fleet vehicle for eligible positions + Referral bonus program _All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, sexual orientation, gender identity, national origin, protected veteran status, or on the basis of disability._ \#LI-TR1 Category Massachusetts TC Astellas is committed to equality of opportunity in all aspects of employment. EOE including Disability/Protected Veterans

Nature and Scope This position is a member of the Quality Assurance team. This position is responsible for ensuring the overall Quality in their assigned areas through the execution of site policies and procedures, programs and work instructions. Ensures all processes and products meet specifications and that products are produced in accordance with GMP requirements. This position is responsible for participating in material receipt, then coordinating sampling and inspection for components, in a sterile manufacturing facility. This position is responsible for ensuring the overall Quality of materials as assigned by Quality Management in coordination with other stakeholders such as Materials Management and Operations, etc. Essential Duties and Responsibilities Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time. * Responsible for execution of procedural documentation as they pertain to various aspects of the receiving and sampling processes. * Performs sampling of components. * Conduct verifications and checks through accurate material inspections. * Identify out of specification materials ensuring segregation and escalation, and perform any activities required within the Trackwise Events system * Management of BPCS for verification and disposition of materials * Maintain retain samples for all primary and secondary components and labeling * Performance of DAF (Destruction Approval) process for rejected materials * Use of Trackwise and Veeva for change controls, as needed * Ensure errors and omissions are resolved according to Standard Operating Procedure (SOP) requirements * Ensure all work is performed and documented in accordance with existing Company policies and procedures, as well as cGMP, health and safety requirements. * Ensure all components and raw materials are appropriately prepared for the applicable status disposition, including all relevant documentation. * Support generation of logbooks and sheets/labels as required. * Basic knowledge of cGMPs and supporting regulatory documents * Perform room, area and equipment clearances that may be necessary for this job function. * Able to perform tasks with minimal error rate. * Assist other Quality Assurance Operations Associates, as needed. * Perform any other tasks/duties as assigned by management. Education Requirements and Qualifications To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required. * High School Diploma or GED equivalent required. Associates or Bachelor's Degree preferred. * At least two (2) years of related experience (QA, Compliance, Auditing, Laboratory or Inspection, within a GMP environment) preferred. * Must be able to do work independently. * Experience in QA working in a cGMP manufacturing environment (preferred) * Working knowledge and understanding of quality assurance principles and familiarity with QA programs * Strong analytical skills, attention to detail and adherence to procedures. * Intermediate skills in Microsoft Word and Excel are required. * Excellent organizational, interpersonal and communication skills (written and oral) required. * Ability to take feedback constructively and function in a team-oriented work environment. * Ability to work overtime as needed. Physical Environment and Requirements * Physically able to wear cleanroom/protective gowning and equipment, including but not limited to gowning, goggles, face shields, respirators, and protective gloves. PPE and Respirators are essential for the health and safety of employees. * Specific vision requirements include 20/20 near vision (can be corrected with eyeglasses or contacts) and color vision. * Employees must maintain a clean-shaven appearance each working shift to wear tight-fitting respirators properly. Employee must be able to occasionally lift and/or move up to 25 pounds. American Regent celebrates diversity and we are committed to creating an inclusive environment for all employees. We are an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, or protected veteran status. Applicants have rights under Federal Employment Laws. * FMLA poster: ********************************************************** * Know Your Rights: Know Your Rights: Workplace discrimination is illegal (eeoc.gov) * Employee Polygraph Protection Act: ********************************************************* Alert: We're aware of individuals impersonating our staff to target job seekers. Please note: * All legitimate communication will come directly from a verified ARI recruiter either by phone or via an americanregent.com email address. * Our recruiting process includes multiple in person and/or video interviews and assessments. * If you are unsure about the legitimacy of a message, contact John Rossini at *************************** before responding. * We never request payment, bank information, or personal financial details during our offer process. Your security is important to us, and we encourage you to stay vigilant when job searching. American Regent Inc. endeavors to make *********************************** accessible to any and all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please email **************************************.

Nature and Scope This position is a member of the Quality Assurance team. This position is responsible for ensuring the overall Quality in their assigned areas through the execution of site policies and procedures, programs and work instructions. Ensures all processes and products meet specifications and that products are produced in accordance with GMP requirements. This position is responsible for participating in material receipt, then coordinating sampling and inspection for components, in a sterile manufacturing facility. This position is responsible for ensuring the overall Quality of materials as assigned by Quality Management in coordination with other stakeholders such as Materials Management and Operations, etc. Essential Duties and Responsibilities Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time. Responsible for execution of procedural documentation as they pertain to various aspects of the receiving and sampling processes. Performs sampling of components. Conduct verifications and checks through accurate material inspections. Identify out of specification materials ensuring segregation and escalation, and perform any activities required within the Trackwise Events system Management of BPCS for verification and disposition of materials Maintain retain samples for all primary and secondary components and labeling Performance of DAF (Destruction Approval) process for rejected materials Use of Trackwise and Veeva for change controls, as needed Ensure errors and omissions are resolved according to Standard Operating Procedure (SOP) requirements Ensure all work is performed and documented in accordance with existing Company policies and procedures, as well as cGMP, health and safety requirements. Ensure all components and raw materials are appropriately prepared for the applicable status disposition, including all relevant documentation. Support generation of logbooks and sheets/labels as required. Basic knowledge of cGMPs and supporting regulatory documents Perform room, area and equipment clearances that may be necessary for this job function. Able to perform tasks with minimal error rate. Assist other Quality Assurance Operations Associates, as needed. Perform any other tasks/duties as assigned by management. Education Requirements and Qualifications To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required. High School Diploma or GED equivalent required. Associates or Bachelor's Degree preferred. At least two (2) years of related experience (QA, Compliance, Auditing, Laboratory or Inspection, within a GMP environment) preferred. Must be able to do work independently. Experience in QA working in a cGMP manufacturing environment (preferred) Working knowledge and understanding of quality assurance principles and familiarity with QA programs Strong analytical skills, attention to detail and adherence to procedures. Intermediate skills in Microsoft Word and Excel are required. Excellent organizational, interpersonal and communication skills (written and oral) required. Ability to take feedback constructively and function in a team-oriented work environment. Ability to work overtime as needed. Physical Environment and Requirements Physically able to wear cleanroom/protective gowning and equipment, including but not limited to gowning, goggles, face shields, respirators, and protective gloves. PPE and Respirators are essential for the health and safety of employees. Specific vision requirements include 20/20 near vision (can be corrected with eyeglasses or contacts) and color vision. Employees must maintain a clean-shaven appearance each working shift to wear tight-fitting respirators properly. Employee must be able to occasionally lift and/or move up to 25 pounds. American Regent celebrates diversity and we are committed to creating an inclusive environment for all employees. We are an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, or protected veteran status. Applicants have rights under Federal Employment Laws. FMLA poster: ********************************************************** Know Your Rights: Know Your Rights: Workplace discrimination is illegal (eeoc.gov) Employee Polygraph Protection Act: ********************************************************* Alert: We're aware of individuals impersonating our staff to target job seekers. Please note: · All legitimate communication will come directly from a verified ARI recruiter either by phone or via an americanregent.com email address. · Our recruiting process includes multiple in person and/or video interviews and assessments. · If you are unsure about the legitimacy of a message, contact John Rossini at *************************** before responding. · We never request payment, bank information, or personal financial details during our offer process. Your security is important to us, and we encourage you to stay vigilant when job searching. American Regent Inc. endeavors to make *********************************** accessible to any and all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please email **************************************.

Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas! Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at ***************** Astellas Institute for Regenerative Medicine (AIRM) is a wholly owned subsidiary of Astellas Pharma Inc and focused on the development and commercialization of stem cell and regenerative medicine therapies. Astellas is an R&D-driven global pharmaceutical company whose philosophy is to contribute to the improvement of people's health around the world through the provision of innovative and reliable pharmaceutical products. AIRM has a world-class R&D team, and is pursuing a diverse range of disease indications, ranging from macular degeneration (currently in clinical trials) and other ocular indications to vascular and autoimmune disease. AIRM's intellectual property portfolio includes pluripotent stem cell platforms -- both embryonic and induced pluripotent stem cells as well as other cell-based therapy research programs. AIRM is headquartered in Massachusetts. Astellas is announcing a QC Scientist I Raw Materials opportunity at their Astellas Institute for Regenerative Medicine (AIRM) site in Westborough, MA. Purpose: The QC Scientist I Raw Materials will be responsible for executing and troubleshooting a variety of laboratory test methods, defining the requirements for implementation of procedures, processes and assays within QC, and identifying and implementing continuous improvement initiatives related to overall laboratory functionality. This role will work closely with the assay transfer technical lead. This role will mentor junior analysts and develop and facilitate training initiatives within the labs. Essential Job Responsibilities: Develop/author/revise technical reports and laboratory procedures (SOPs, methods) Execute and troubleshoot raw material testing in support of production activities Perform routine release sampling and managing testing of raw materials, such as compendial analysis per USP, Ph.Eur., and JP monographs and general chapters, based on cGMP and internal procedures Design and perform testing in support of method transfer/validation/qualification/verification Review/authorize data and perform analysis and interpretation of test results and trends Design and/or participate in method development; equipment qualification/validation studies; deviation and OOS investigations Perform QC lab support activities including but not limited to sample management, reagent preparation, instrumentation maintenance, and instrument calibration Support and mentor junior team members Collaborate with other network sites to share best practices Other duties as required Quantitative Dimensions: The QC Scientist I Raw Materials will be accountable for executing and troubleshooting a variety of laboratory test methods, defining the requirements for implementation of procedures, processes and assays within QC, and identifying and implementing continuous improvement initiatives related to overall laboratory functionality. Organizational Context: The QC Scientist I Raw Materials will typically report to the Senior Manager, Quality Control Raw Materials. This role is expected to Model our Core Values and to demonstrate work performance as someone who exemplifies the culture we want to create; operates with transparency; is trusted; and supports the overall mission and vision of Astellas Gene Therapies and the Astellas organization

Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas! Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at ***************** Astellas Institute for Regenerative Medicine (AIRM) is a wholly owned subsidiary of Astellas Pharma Inc and focused on the development and commercialization of stem cell and regenerative medicine therapies. Astellas is an R&D-driven global pharmaceutical company whose philosophy is to contribute to the improvement of people's health around the world through the provision of innovative and reliable pharmaceutical products. AIRM has a world-class R&D team, and is pursuing a diverse range of disease indications, ranging from macular degeneration (currently in clinical trials) and other ocular indications to vascular and autoimmune disease. AIRM's intellectual property portfolio includes pluripotent stem cell platforms -- both embryonic and induced pluripotent stem cells as well as other cell-based therapy research programs. AIRM is headquartered in Massachusetts. Astellas is announcing a QC Scientist I Raw Materials opportunity at their Astellas Institute for Regenerative Medicine (AIRM) site in Westborough, MA. Purpose: The QC Scientist I Raw Materials will be responsible for executing and troubleshooting a variety of laboratory test methods, defining the requirements for implementation of procedures, processes and assays within QC, and identifying and implementing continuous improvement initiatives related to overall laboratory functionality. This role will work closely with the assay transfer technical lead. This role will mentor junior analysts and develop and facilitate training initiatives within the labs. Essential Job Responsibilities: * Develop/author/revise technical reports and laboratory procedures (SOPs, methods) * Execute and troubleshoot raw material testing in support of production activities * Perform routine release sampling and managing testing of raw materials, such as compendial analysis per USP, Ph.Eur., and JP monographs and general chapters, based on cGMP and internal procedures * Design and perform testing in support of method transfer/validation/qualification/verification * Review/authorize data and perform analysis and interpretation of test results and trends * Design and/or participate in method development; equipment qualification/validation studies; deviation and OOS investigations * Perform QC lab support activities including but not limited to sample management, reagent preparation, instrumentation maintenance, and instrument calibration * Support and mentor junior team members * Collaborate with other network sites to share best practices * Other duties as required Quantitative Dimensions: The QC Scientist I Raw Materials will be accountable for executing and troubleshooting a variety of laboratory test methods, defining the requirements for implementation of procedures, processes and assays within QC, and identifying and implementing continuous improvement initiatives related to overall laboratory functionality. Organizational Context: The QC Scientist I Raw Materials will typically report to the Senior Manager, Quality Control Raw Materials. This role is expected to Model our Core Values and to demonstrate work performance as someone who exemplifies the culture we want to create; operates with transparency; is trusted; and supports the overall mission and vision of Astellas Gene Therapies and the Astellas organization

By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description Objective / Purpose: The Head of Research Quality holds the highest leadership role within the Research Quality organization and serves as a key member of the R&D Quality leadership team. This executive is fully accountable for defining and executing the global strategic vision for Research Quality, overseeing a global team of experienced subject-matter experts dedicated to ensuring integrity, compliance, and ethical excellence in non-clinical research activities, studies, and processes supporting Takeda's R&D pipeline. Through strategic leadership, impactful stakeholder engagement, and championing an enterprise-wide quality culture, the Head of Research Quality drives organizational success and reinforces Takeda's commitment to industry-leading standards. Accountabilities: Establish and implement a comprehensive global strategic vision for Research Quality, ensuring sustained and impactful contributions to the enterprise. Align this vision with the overarching goals of Research and R&D Quality leadership. Design oversight strategies and effectively deploy resources to mitigate compliance risks for Research non-clinical studies conducted externally in non-OECD Mutual Acceptance of Data system countries. Cultivate influential relationships with key stakeholders to maintain an in-depth understanding of R&D and Research strategies. Leverage this insight to proactively anticipate and address impacts on Research Quality, driving business growth and success. Direct the Research Quality function in designing, implementing, and refining processes that ensure Takeda's non-clinical Research activities are conducted with the highest integrity and compliance with Takeda standards and global regulatory requirements. Architect strategies to foster a culture of continuous improvement, leading initiatives across internal stakeholder groups to uphold quality, compliance, and data integrity throughout Research programs and projects. Spearhead digital transformation and the adoption of cutting-edge science and technology to support data-driven processes and decision-making within Research Quality. Mentor and empower direct and indirect reports across Research Quality, promoting personal development and driving high-performance teams. Develop and sustain collaborative relationships with Research leaders to facilitate productive discussions and align strategies and priorities. Provide strategic oversight to enhance capabilities, mechanisms, and processes for proactive quality risk management across the global Research organization's activities and programs. Maintain and expand knowledge of global regulatory requirements and trends, identifying gaps and implementing solutions to position Takeda at the forefront of industry expectations. Implement strategies for the ongoing development and success of Research Quality, including talent development, succession planning, resource allocation, and budget management, aligning initiatives with R&D Quality and Global Quality. Offer strategic input to the R&D Quality Leadership team on key goals, initiatives, resource planning, and budgetary considerations, ensuring alignment with organizational objectives. Drive strategic alignment and successful achievement of shared goals through collaboration with other functions in R&D Quality and Global Quality. Identify areas of risk and improvement, presenting solutions to address these challenges effectively. Undertake additional duties as assigned, contributing to the overall success of the organization. Education & Competencies (Technical and Behavioral): Minimum requirements: Bachelor's Degree in Chemistry, Biology, Engineering or related field 12+ years of increasing responsibility and experience in the biopharma/biotech industry 8+ years of Quality/Compliance experience Prior management experience Preferred requirements: Advanced degree in Chemistry, Biology, Engineering or related field Experience working in biopharmaceutical research Desired skills & competencies In-depth knowledge of global regulations governing biopharmaceutical research, with the ability to effectively translate and articulate strategies to ensure compliance. Proven leadership, collaboration, and influencing skills, coupled with a demonstrated ability to solve problems and drive impactful change. Proficiency in working with diverse individuals across all organizational levels. Exceptional interpersonal, verbal, and written communication skills, enabling successful interaction with internal stakeholders and vendors. Adaptability and flexibility to thrive in dynamic environments, along with the ability to manage and deliver multiple projects on time. Strong attention to detail and organizational expertise, with a capacity to work independently across global settings and navigate organizational complexities. #GMSGQ #ZR1 #LI-LR1 Takeda Compensation and Benefits Summary We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. For Location: Boston, MA U.S. Base Salary Range: $208,200.00 - $327,140.00 The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location. U.S. based employees may be eligible for short-term and/ or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation. EEO Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law. LocationsBoston, MAWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull time Job Exempt YesIt is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins laboratories work with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate. The Eurofins network of companies is the global leader in food, environment, pharmaceutical and cosmetic product testing and in agroscience Contract Research Organisation services. It is one of the market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, advanced material sciences and in the support of clinical studies, as well as having an emerging global presence in Contract Development and Manufacturing Organisations. It also has a rapidly developing presence in highly specialised and molecular clinical diagnostic testing and in-vitro diagnostic products. In over 30 years, Eurofins has grown from one laboratory in Nantes, France to 58,000 staff across a decentralised and entrepreneurial network of 900 laboratories in over 54 countries. Eurofins companies offer a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products. In 2021, Eurofins generated total revenues of EUR 6.72 billion, and has been among the best performing stocks in Europe over the past 20 years. Job Description * Perform evaluations and laboratory testing on primary container-closure components and system, critical secondary packaging, and shipping systems utilizing mechanical testing equipment, dimension measurement instruments, and container closure integrity testing systems * Execute methods, collect data, and document results in lab notebooks and LIMS * Participate in the development of laboratory test methods or equipment to ensure reliability and accuracy of results * Interact with colleagues in other groups on a routine basis * Ensure all activities follow established safety standards, regulatory requirements and Good Manufacturing Procedures (GMP) Qualifications * Bachelor's in science, engineering, or technology, or equivalent directly-related experience (two years of directly related industry experience is equivalent to one full-time year of college in related major) * At least 4-10 years of related laboratory experience Additional Information * Position is full-time, Monday-Friday, 8:00 am - 5:00 pm. * Candidates currently living within a commutable distance of Indianapolis, IN are encouraged to apply * Excellent full-time benefits including comprehensive medical coverage, dental, and vision options * Life and disability insurance * 401(k) with company match * Paid vacation and holidays * #LI-EB1 * Authorization to work in the United States indefinitely without restriction or sponsorship Eurofins USA PSS Insourcing Solutions is a Disabled and Veteran Equal Employment Opportunity employer.

As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development, and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in several ways to foster a healthy working environment, meaningful work, mobility, networking, and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees. The Associate Scientist, Bio QC performs bio-analytical methods (immunological, in vivo, microbiological, molecular biological, or virological) for various Bio QC tests on raw materials, in-process, release or stability samples in compliance with 9CFR, EU and VICH regulatory guidelines, Outlines of Production and Special Outlines. This role initiates, executes and completes assays as per validated procedures and within Quality and Compliance guidelines and communicates testing results, compliance and/or scheduling issues to supervisors. **Duties & Responsibilities** + Performs routine testing using a portion of the existing laboratory assays. + Maintains laboratory reagents, supplies and calibrated equipment. + Prepares reagents and materials. + Calculates test results. + Communicates schedule, test status and concerns. + Reviews and approves results and test sheets. + Revises a Pre-existing Standard Methods and SOPs. + Trains others on methods & procedures. **Requirements** + High school degree or GED with a minimum of five (5) years of relevant Bio QC testing or relevant experience in a cGMP or similar environment. OR + Associate's degree in relevant scientific discipline and a minimum of two (2) years of Bio QC testing or relevant experience in a cGMP or similar environment. OR + Bachelor's degree in relevant scientific discipline with or without additional Bio QC testing experience. + Bachelor's degree in a scientific discipline with one-plus (1+) years of Bio QC testing experience in a cGMP or similar manufacturing environment is preferred. + Knowledge of basic scientific principles and techniques. + Ability to effectively communicate in a clear, concise and appropriate manner. + Documents results and data clearly and accurately. + Effectively interacts with co-workers and others as needed. + Demonstrates teamwork within own group and other internal groups. + Use of Word and Excel, QM software for data management (SAP), MRP inventory software, and Document Management System) **Eligibility Requirements** : + Must be legally authorized to work in the United States without restriction. + Must be willing to take a drug test and post-offer physical (if required). + Must be 18 years of age or older. All qualified applicants will receive consideration for employment without regard to a person's actual or perceived race, including natural hairstyles, hair texture and protective hairstyles; color; creed; religion; national origin; age; ancestry; citizenship status, marital status; gender, gender identity or expression; sexual orientation, mental, physical or intellectual disability, veteran status; pregnancy, childbirth or related medical condition; genetic information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable law.

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients. **We are PCI.** Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI. **Summary of Objective:** Conducts sampling and testing of production environments, and/or facility clean utilities, as per approved procedures. Performs Lab work and other tasks as assigned by management. **Essential Duties and Responsibilities:** To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The essential duties and responsibilities include the following but other duties may be assigned. - Perform routine Environmental Monitoring of the classified clean rooms - Monitor classified clean rooms during manufacturing operations, must gown qualify - Sample and test the Water for Injection System, USP Purified Water systems and Clean Steam systems; perform and document plate reads for all environmental and utility testing with minimal supervision - Write and execute protocols/experiments/SOPs under limited supervision - Reviews work of peers and SOP document changes under limited supervision - May assist senior staff in preparation of investigations, reports and execution of complex protocols - Visual inspection of media fill vials and plates - Perform general lab maintenance/housekeeping - Training of staff in routine processes - Other duties as assigned **Special Demands:** The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. The employee must be physically capable to perform the duties listed below with or without reasonable accommodations which may be made to enable individuals with disabilities to perform the essential functions. - Required to stand; walk; sit; use hands to finger, handle or feel objects, tools or controls; reach with hands and arms; balance; talk and hear - Ability to sit or stand for prolonged periods of time - Must be able to walk and drive between locations - Physically able to wear laboratory protective gowning and equipment, including but not limited to gowning, goggles, face shields, and protective gloves - Must be able to occasionally lift and/or move up to 50 pounds - Must pass eye exam - Comfortable with working/handling of hazardous materials - Follow written instructions. Perform independent troubleshooting of common issues. - Able to work in a highly complex environment with competing demands and priorities **Work Environment:** The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. - Required to stand; walk; sit; use hands to finger, handle or feel objects, tools or controls; reach with hands and arms; balance; talk and hear. - Ability to sit or stand for prolonged periods of time. - Physically able to wear laboratory protective gowning and equipment, including but not limited to gowning, goggles, face shields, and protective gloves. - Must be able to occasionally lift and/or move up to 25 pounds. - Follow written instructions. Perform independent troubleshooting of common issues. Provide expertise for response to complex issues. - Able to work in a highly complex environment with competing demands and priorities. **Qualifications:** The requirements listed below are representative of the knowledge, skill, and/or ability required for the stated position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. - High School Diploma required. BS/BA degree in Microbiology or related scientific field preferred. - 3-5 years' experience in a cGMP environment. Two years of experience may be replaced by Associates/Non- Scientific Bachelor's degree. Four years of experience may be replaced with BS/BA degree in Microbiology or related scientific field. - Detail oriented - Ability to multi-task - Ability to gown to work in an ISO-5 environment - Ability to work varied hours as required by the production schedule **\#LI - LL1** Join us and be part of building the bridge between life changing therapies and patients. Let's talk future (***************** **Equal Employment Opportunity (EEO) Statement:** _PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status._ _At PCI, Equity and Inclusion are at the core of our company's purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture._ Why work for PCI Pharma Services? At PCI, we have an uncompromising focus on providing quality and operational excellence and providing the industry leading customer experience. Our people make all of this happen, so providing an industry leading experience for our people is equally as important. By creating an authentic culture of purposeful work, we aspire to be an interesting and fulfilling place for talented individuals to grow careers. We live a philosophy of intentional learning combined with real-life experience supported by a fair and competitive rewards program. We are individuals, teams and a company that believes in our purpose and our approach is simple, the people who work at PCI fuel our business; we don't say no, we figure out how. PCI Pharma Services is an Equal Opportunity Employer/Vet/Disabled

1. Maintain the highest standards of scientific professionalism. When in doubt, get feedback from other R&D/Technical professionals. 2. Maintain detailed and comprehensive documentation of all work performed. 3. Stay current with the scientific literature, particularly in areas that may affect companys product line, existing processes or potential commercial opportunities. 4. Evaluate technology packages from external sources for chemical and cost-effective viability, as directed. 5. Perform literature searches for development work, potential projects, and to support QA/QC and Environmental/Health & Safety. 6. Provide ideas for investigation with an emphasis on commercialization, patent opportunity, or publication on a regular basis. 7. Provide support to QA/QC by writing analytical SOPs. 8. Communicate results by providing timely reports and project updates, to include technical reports and summaries for company business units and customers. 9. Provide monthly report on progress of work to the department head. 10. Provide help on preparation of quarterly/yearly R&D summaries of ongoing work to peers and senior management. 11. Plan and develop robust analytical methods including troubleshooting and validation, as appropriate. 12. Work closely with Synthesis group and support on routine analysis. 13. Work closely with Quality Assurance (QA) and Quality Control (QC) to identify project needs and to insure strict compliance with internal quality and/or cGMP/ICH guidelines. 14. Work closely with QA on validation efforts for new API processes to insure strict cGMP compliance, where appropriate. 15. Work closely with R&D team to answer DMF deficiencies and customer queries. 16. Maintain rigorous accountability and documentation of work related to controlled substances in accordance with established SOPs and requirements of federal regulations (21 CFR Part 1300-1399). 17. Adhere to all relevant company SOPs and guidelines, and provide input for correcting and changing existing procedures and processes. 18. Provide technical support as needed for company products, analytical methods and customer-driven issues, as needed. 19. Provide necessary information on cost-saving and time-saving alternatives to current analytical and laboratory practices whenever and wherever possible. 20. Assist in supervision of R&D laboratory operations in general, including troubleshooting of lab systems and instrumentation. 21. Work with Health, Safety and Environmental representative to identify waste stream data and possible hazards for potential products and processes. 22. Assist in the maintenance and cleaning of the R&D laboratory in general and in individual workspace in particular. 23. Seek out opportunities for professional development. 24. Select and purchase R&D chemicals, glassware and supplies, and track these orders using the established R&D purchase requisition system. 25. Execute R&D stability program, to include writing and following stability protocols, and packaging and testing APIs, as well as compiling and reporting stability results to R&D manager. 26. Facilitate the training system within the R&D department in coordination with the requirements set forth by QA. 27. Other duties as assigned. **Position Requirements:** + B.S. degree in Chemistry (preferable), Chemical Engineering, or related discipline. + Ability and attitude to assume a leadership role and work in a productive technical team within an industrial research environment. + Ability to communicate effectively through verbal, written, presentation and computer modes of expression. + Ability to confidently represent company on technical matters to customers, senior management, and at scientific venues (conferences and publications). We provide equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, military or veteran status, generic predisposing characteristics or any other basis prohibited by law.

* Maintain the highest standards of scientific professionalism. When in doubt, get feedback from other R&D/Technical professionals. * Maintain detailed and comprehensive documentation of all work performed. * Stay current with the scientific literature, particularly in areas that may affect company's product line, existing processes or potential commercial opportunities. * Evaluate technology packages from external sources for chemical and cost-effective viability, as directed. * Perform literature searches for development work, potential projects, and to support QA/QC and Environmental/Health & Safety. * Provide ideas for investigation with an emphasis on commercialization, patent opportunity, or publication on a regular basis. * Provide support to QA/QC by writing analytical SOPs. * Communicate results by providing timely reports and project updates, to include technical reports and summaries for company business units and customers. * Provide monthly report on progress of work to the department head. * Provide help on preparation of quarterly/yearly R&D summaries of ongoing work to peers and senior management. * Plan and develop robust analytical methods including troubleshooting and validation, as appropriate. * Work closely with Synthesis group and support on routine analysis. * Work closely with Quality Assurance (QA) and Quality Control (QC) to identify project needs and to insure strict compliance with internal quality and/or cGMP/ICH guidelines. * Work closely with QA on validation efforts for new API processes to insure strict cGMP compliance, where appropriate. * Work closely with R&D team to answer DMF deficiencies and customer queries. * Maintain rigorous accountability and documentation of work related to controlled substances in accordance with established SOPs and requirements of federal regulations (21 CFR Part 1300-1399). * Adhere to all relevant company SOPs and guidelines, and provide input for correcting and changing existing procedures and processes. * Provide technical support as needed for company products, analytical methods and customer-driven issues, as needed. * Provide necessary information on cost-saving and time-saving alternatives to current analytical and laboratory practices whenever and wherever possible. * Assist in supervision of R&D laboratory operations in general, including troubleshooting of lab systems and instrumentation. * Work with Health, Safety and Environmental representative to identify waste stream data and possible hazards for potential products and processes. * Assist in the maintenance and cleaning of the R&D laboratory in general and in individual workspace in particular. * Seek out opportunities for professional development. * Select and purchase R&D chemicals, glassware and supplies, and track these orders using the established R&D purchase requisition system. * Execute R&D stability program, to include writing and following stability protocols, and packaging and testing APIs, as well as compiling and reporting stability results to R&D manager. * Facilitate the training system within the R&D department in coordination with the requirements set forth by QA. * Other duties as assigned. Position Requirements: * B.S. degree in Chemistry (preferable), Chemical Engineering, or related discipline. * Ability and attitude to assume a leadership role and work in a productive technical team within an industrial research environment. * Ability to communicate effectively through verbal, written, presentation and computer modes of expression. * Ability to confidently represent company on technical matters to customers, senior management, and at scientific venues (conferences and publications). Nearest Major Market: Chattanooga

Boehringer Ingelheim Animal Health is currently seeking an innovative, tech savvy Co-Op to join our Commercial Quality team located at our Duluth, GA US headquarters. As a Co-Op, you will learn basic quality principles while performing critical process evaluations. The mission of this internship will be to streamline a critical quality process which contributes to the continuity of the US Animal Health Commercial Supply Chain. As a Co-Op at Boehringer Ingelheim, you will actively contribute to the discovery, development, and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in several ways to foster a healthy working environment, meaningful work, mobility, networking, and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees. Duties & Responsibilities Assist Subject Matter Experts in core quality tasks associated with release of batches to the US market, deviation management, and complaint management Evaluate a core quality process and use BI digital tools (i.e. Tableau, Power BI, Dashboards, Excel, DocuSign) to streamline the process Develop and execute quality culture initiatives to spread Quality Culture across the US AH Commercial business Requirements Must be a current undergraduate, graduate or advanced degree student in good academic standing. Student must be enrolled at an accredited college or university for the duration of the Co-Op. Overall cumulative minimum GPA from last completed quarter/semester 3.0 GPA (on a 4.0 scale) preferred. Major or minor in related field of the Co-Op. Undergraduate students must have completed at least 12 credit hours at current college or university. Graduate and advanced degree students must have completed at least 9 credit hours at current college or university. Desired Skills, Experience and Abilities Advanced skills in Excel, Dashboards, and/or Power BI Strong organization skills Proficient in MS PowerPoint Excellent written and verbal communication Eligibility Requirements: Must be legally authorized to work in the United States without restriction. Must be willing to take a drug test and post-offer physical (if required). Must be 18 years of age or older.

The Quality Control Operator ensures the products meet their respective specifications and quality standards by performing physicochemical analyzes, measurement testing, and monitoring steps of the production process. Responsibilities: Product sampling and quality monitoring. Physicochemical analysis of food products. Measurement testing, such as finished product weight and oxygen level. Critical Control Point (CCP) monitoring. Maintenance of quality control records. Compliance with the QA laboratory procedures. Compliance with Good Manufacturing Practices (GMP), and Quality & Food Safety guidelines. Support the 5S program in the manufacturing facility, keeping working areas, utensils, and equipment clean and organized. Compliance with company safety rules and procedures, providing support to eliminate any unsafe conditions. Support to all quality shifts, as needed. Any other duties assigned by the management. Education/Experience/Knowledge: High School Graduate or equivalent work experience. Basic computer skills including Microsoft Office applications and Windows environment. Ability to do math computation and calculation. Ability to maintain a positive work atmosphere by behaving and communicating professionally and effectively with others as well as being able to receive feedback from others. Time management and teamwork skills. Verbal and written communication skills. High level of integrity. Able to work on the weekends, as needed. Bilingual (English and Spanish), preferred. Why work for Advance Services, Inc. 1. Advance Services is for and about people; we are your employment specialists. 2. Enjoy our easy application process. 3. You NEVER pay a fee! 4. Weekly pay. 5. Fun Safety and attendance incentives. 6. Health Benefits to keep you and your family healthy. 7. PTO so you have time for yourself. 8. Great Referral Incentives. 9. Advance Services partners with the top companies in the area! Apply for this job by clicking the apply button. You will be directed to our website. Please select a branch near you or call/text our office at *************. Stop in and see our experienced, friendly staff at 1908 Central Dr, Suite A, Bedford, TX 76021. Advance Services is an equal-opportunity employer.#456

The Scientist 3 - QC is responsible to perform testing of raw materials, in-process and finished pharmaceutical dosage forms, products on stability, cleaning verification samples following written procedures and applicable SOPs, calculate and report results on applicable specification documents, participate in method transfer activities within departments or between facilities or organizations. This role will also provide feedback on systems and analytical procedures to promote continuous improvement and enhancement of compliance posture. Essential Functions: * Perform physical and chemical analysis of raw materials, in-process, and finished pharmaceutical products, including products on stability, according to written methods, material specification, and company policies as identified in standard operating procedures (SOPs). Comply with cGMps, SOPs, and STPs to avoid out-of-specification situation. Assure compliance with state and federal regulations. * Actively participate in any project work as and when assigned. Perform process validation and cleaning validation/verification testing on various drugs. Assist other scientists with analytical, instrument and software related problems as required. * Use sonic sifter, laser diffraction, Karl Fischer, UV-Vis spectrophotometer, Infra-red spectrophotometer, HPLC with UV detection as well as with conductivity detection, TLC, pH meter, and dissolution. Calibrate HPLC, Dissolution apparatus equipped with auto-sampler and /or in-line UV, pH meters, analytical balances, and Karl-Fischer titrator. * Document steps followed during analysis execution, calculate and report results. Actively participate in investigation of laboratory results. * Review laboratory analysis data for completeness, specification compliance, and compliance with company's written policies. * Report any abnormal findings to the Supervisor. As assigned, perform in-depth review of analytical records/reports to assure that calculations and other data are technically correct and compliant to relevant specifications. Additional Responsibilities: * Assist the laboratory supervisor with handling non-routine special projects requiring activities such as out-of-specification investigations and out-of-alert limit investigations in the laboratory. * Ensure that expired chemicals and reference standards are removed from laboratory area. * Perform calibration of HPLC, GC, and other equipment as assigned by the supervisor. * Assist with hands-on training of newly hired Technicians or Scientists 1 and 2 levels.

Job DescriptionAbout Us At The Pharmacy Hub, we collaborate with pharmaceutical brands, manufacturers, health brands, telemedicine providers, and healthcare companies to deliver essential products directly to patients. Our expertise allows us to seamlessly distribute pharmaceuticals, medical devices, and other healthcare products to consumers, ensuring greater accessibility and convenience. Core Values The Pharmacy Hub is dedicated to breaking barriers in healthcare by championing access, intervention and affordability. Customer-first mindset - we develop strong partnerships with telehealth platforms and healthcare companies to enhance access and understand their specific needs Innovation for intervention in care - we develop advanced compounding solutions and products to better support patient health outcomes Continuous improvement - we continuously improve our processes and offerings through intelligent, honest and transparent practices to deliver cost-effective solutions that truly benefit our clients and their patients. You will play a pivotal role in maintaining these values and contributing to the company's mission of redefining healthcare delivery through superior pharmacy services. Position Overview We are seeking a Compliance & Quality Control Officer with strong experience in the pharmaceutical industry to ensure our operations meet all regulatory and quality standards. This role oversees compliance for 305a mail- order pharmacy, receiving 305b outsourcing medication, retail pharmacy medications, and controlled substances (Schedules III & IV). In addition, the Compliance Officer will lead the Quality Control Department, supervising a team of at least four staff members to maintain the highest standards of accuracy, safety, and compliance. Key Responsibilities Compliance Oversight Ensure compliance with 503a mail-order, 503b outsourcing facilities, and retail pharmacy regulations. Maintain 50-state licensure and handle renewals, audits, and regulatory filings. Ensure strict adherence to DEA regulations for Schedule III & IV controlled substances. Oversee OSHA compliance for warehouse operations, including forklift use and high-level storage safety. Quality Control Leadership Lead and manage the Quality Control Department, supervising a team of at least four. Set quality benchmarks and ensure products meet safety, accuracy, and regulatory requirements. Provide training, guidance, and performance evaluations to QC staff. Coordinate with pharmacy, warehouse, and operations teams to resolve quality or compliance issues. Risk Management & Reporting Conduct internal audits and prepare for external inspections. Investigate incidents, document findings, and implement corrective actions. Utilize advanced software and tracking tools for compliance and quality reporting. Qualifications Minimum 3-5 years of compliance and quality control experience in the pharmaceutical industry. Demonstrated ability to lead, supervise, and develop a team. Strong computer and reporting system skills. Bilingual (Spanish & English) - required. Strong knowledge of DEA controlled substance rules (Schedules III & IV) and OSHA warehouse standards. Excellent organizational, communication, and problem-solving skills. Ability to work a flexible schedule as compliance needs require. Work Schedule Standard: Monday to Friday, 8:00 a.m. - 4:30 p.m. Must be flexible to adapt to inspections, audits, or urgent compliance/quality needs. Salary: Salary is to be determined and will be negotiable based on experience. Pay Range$55,000-$75,000 USD Benefits: 401(k) with up to 4% matching Medical, dental, vision and life insurance Paid time off Paid public holidays At The Pharmacy Hub, we don't just offer jobs-we offer opportunities for career growth and development. We take pride in our fast-paced, team-driven culture and are committed to supporting our employees in achieving success. If you're ready to join a company that values hard work, dedication, and teamwork, apply today! We look forward to welcoming you to The Pharmacy Hub and working together to deliver top-tier pharmacy fulfillment solutions.

About Us At The Pharmacy Hub, we collaborate with pharmaceutical brands, manufacturers, health brands, telemedicine providers, and healthcare companies to deliver essential products directly to patients. Our expertise allows us to seamlessly distribute pharmaceuticals, medical devices, and other healthcare products to consumers, ensuring greater accessibility and convenience. Core Values The Pharmacy Hub is dedicated to breaking barriers in healthcare by championing access, intervention and affordability. Customer-first mindset - we develop strong partnerships with telehealth platforms and healthcare companies to enhance access and understand their specific needs Innovation for intervention in care - we develop advanced compounding solutions and products to better support patient health outcomes Continuous improvement - we continuously improve our processes and offerings through intelligent, honest and transparent practices to deliver cost-effective solutions that truly benefit our clients and their patients. You will play a pivotal role in maintaining these values and contributing to the company's mission of redefining healthcare delivery through superior pharmacy services. Position Overview We are seeking a Compliance & Quality Control Officer with strong experience in the pharmaceutical industry to ensure our operations meet all regulatory and quality standards. This role oversees compliance for 305a mail- order pharmacy, receiving 305b outsourcing medication, retail pharmacy medications, and controlled substances (Schedules III & IV). In addition, the Compliance Officer will lead the Quality Control Department, supervising a team of at least four staff members to maintain the highest standards of accuracy, safety, and compliance. Key Responsibilities Compliance Oversight Ensure compliance with 503a mail-order, 503b outsourcing facilities, and retail pharmacy regulations. Maintain 50-state licensure and handle renewals, audits, and regulatory filings. Ensure strict adherence to DEA regulations for Schedule III & IV controlled substances. Oversee OSHA compliance for warehouse operations, including forklift use and high-level storage safety. Quality Control Leadership Lead and manage the Quality Control Department, supervising a team of at least four. Set quality benchmarks and ensure products meet safety, accuracy, and regulatory requirements. Provide training, guidance, and performance evaluations to QC staff. Coordinate with pharmacy, warehouse, and operations teams to resolve quality or compliance issues. Risk Management & Reporting Conduct internal audits and prepare for external inspections. Investigate incidents, document findings, and implement corrective actions. Utilize advanced software and tracking tools for compliance and quality reporting. Qualifications Minimum 3-5 years of compliance and quality control experience in the pharmaceutical industry. Demonstrated ability to lead, supervise, and develop a team. Strong computer and reporting system skills. Bilingual (Spanish & English) - required. Strong knowledge of DEA controlled substance rules (Schedules III & IV) and OSHA warehouse standards. Excellent organizational, communication, and problem-solving skills. Ability to work a flexible schedule as compliance needs require. Work Schedule Standard: Monday to Friday, 8:00 a.m. - 4:30 p.m. Must be flexible to adapt to inspections, audits, or urgent compliance/quality needs. Salary: Salary is to be determined and will be negotiable based on experience. Pay Range$55,000-$75,000 USD Benefits: 401(k) with up to 4% matching Medical, dental, vision and life insurance Paid time off Paid public holidays At The Pharmacy Hub, we don't just offer jobs-we offer opportunities for career growth and development. We take pride in our fast-paced, team-driven culture and are committed to supporting our employees in achieving success. If you're ready to join a company that values hard work, dedication, and teamwork, apply today! We look forward to welcoming you to The Pharmacy Hub and working together to deliver top-tier pharmacy fulfillment solutions.

The Scientist 3 - QC is responsible to perform testing of raw materials, in-process and finished pharmaceutical dosage forms, products on stability, cleaning verification samples following written procedures and applicable SOPs, calculate and report results on applicable specification documents, participate in method transfer activities within departments or between facilities or organizations. This role will also provide feedback on systems and analytical procedures to promote continuous improvement and enhancement of compliance posture. Essential Functions: Perform physical and chemical analysis of raw materials, in-process, and finished pharmaceutical products, including products on stability, according to written methods, material specification, and company policies as identified in standard operating procedures (SOPs). Comply with cGMps, SOPs, and STPs to avoid out-of-specification situation. Assure compliance with state and federal regulations. Actively participate in any project work as and when assigned. Perform process validation and cleaning validation/verification testing on various drugs. Assist other scientists with analytical, instrument and software related problems as required. Use sonic sifter, laser diffraction, Karl Fischer, UV-Vis spectrophotometer, Infra-red spectrophotometer, HPLC with UV detection as well as with conductivity detection, TLC, pH meter, and dissolution. Calibrate HPLC, Dissolution apparatus equipped with auto-sampler and /or in-line UV, pH meters, analytical balances, and Karl-Fischer titrator. Document steps followed during analysis execution, calculate and report results. Actively participate in investigation of laboratory results. Review laboratory analysis data for completeness, specification compliance, and compliance with company's written policies. Report any abnormal findings to the Supervisor. As assigned, perform in-depth review of analytical records/reports to assure that calculations and other data are technically correct and compliant to relevant specifications. Additional Responsibilities: Assist the laboratory supervisor with handling non-routine special projects requiring activities such as out-of-specification investigations and out-of-alert limit investigations in the laboratory. Ensure that expired chemicals and reference standards are removed from laboratory area. Perform calibration of HPLC, GC, and other equipment as assigned by the supervisor. Assist with hands-on training of newly hired Technicians or Scientists 1 and 2 levels. Education: Bachelors Degree (BA/BS) Chemistry or related science discipline - Required Master Degree (MS/MA) Chemistry or related science discipline - Preferred Experience: With a Bachelors Degree (BA/BS) -5 years or more of testing of chemicals/pharmaceutical products With a Masters Degree (BA/BS) -3 years or more of testing of chemicals/pharmaceutical products Skills: Must be precise and consistent in day to day analysis, easily trainable and ready to learn. - Advanced Must be able to work in a team environment and be flexible to easily adapt to changes in assignments. - Advanced Must be able to execute compendial procedures involving complexity with no or minimal supervision. - Intermediate Must be able to effectively communicate results, problems or issues, verbally as well as in writing. - Intermediate Must be able to assume a role of a leader in team environment as and when required. - Intermediate Must be computer literate and savvy with MS office applications, software programs related to LIMS. - Intermediate Must be willing to work extended hours, including weekends, as and when required. - Intermediate Must follow safe practices as identified in appropriate MSDS during working with chemicals, and must follow applicable state and federal regulations. - Advanced Must be capable of maintaining clear and concise laboratory records and communicating clearly both within and between departments. - Advanced Must be thoroughly familiar with cGMP applicable to laboratories in pharmaceutical settings and with method verification/validation concepts. - Advanced Must be able to review laboratory records to ascertain compliance with applicable specifications, methods, and SOPs. - Intermediate Specialized Knowledge: Must possess in-depth knowledge of analytical chemistry techniques, such as spectrophotometric, dissolution and drug release, chromatographic techniques (standalone or hypenated) and measuring physical parameters (viscosity, particle size or droplet size by laser diffraction, melting point by DSC, water content by TGA, identification by XRPD, and other techniques). Must be able to follow compendial (USP/EP/BP/JP) procedures for analysis. Must understand and apply cGMP requirements applicable to quality control laboratory. Must have ability to apply advanced technical skills to troubleshoot and resolve complex analytical and instrument-related problems effectively and in a timely manner and report actions to the laboratory management in a timely manner. Must be able to identify trends in analytical data. The base salary for this position ranges from $90,000 to $95,000 per year. Amneal ranges reflect the Company's good faith estimate of base salary that Amneal reasonably believes that it will pay for said position at the time of the posting. Individual compensation will ultimately be determined based on a variety of relevant factors, including but not limited to, qualifications, geographic location and other relevant skills. At the heart of our Total Rewards commitment is a comprehensive, flexible and competitive benefits program for eligible positions that enables you to choose the plans and coverage that meet your personal needs. This includes above-market, diverse and robust health and insurance benefits to meet the varied needs of our employees as well as a significant 401(k) matching contribution to help our employees save for retirement. We also promote employee well-being with programs that helps you enjoy your career alongside life's many other commitments and opportunities.

Job Description This position functions primarily in a classified ISO-8 environment and requires the individual to wear appropriate PPE. This position will perform dispensing and formulation operations and perform other duties, such as cleaning, restocking, visual inspection, and labeling, as required and/or assigned. All assigned tasks must be conducted in adherence with all applicable procedures, cGMPs, company policies and any other quality or regulatory (Ex: OSHA, DEA, FDA, etc.) requirements. Facility is a multiple shift operation where variable shifts, including weekends, may be required. Schedule: Tuesday to Friday 3 PM Until 1:30 AM (or until work is completed) Pay: $25/hour SAFETY Strictly adhere to all cGMP, health and safety requirements, procedures, and corporate policies. Authorized to immediately stop any task that is determined to be an imminent hazard. Always promote and demonstrate safe work practices and adhere to PPE requirements. Safely handle chemicals, corrosives, solvents, and other pharmaceutical compounds. Demonstrate physical ability to lift a minimum of 50 lbs. and push/pull pallets, product cans, etc. multiple times per shift. PRIMARY RESPONSIBILITIES: Perform ISO-8 dispensing and formulation operations consistent with established protocols, procedures, and regulatory/cGMP requirements. Learn to utilize all relevant equipment/technology for formulation operations. Complete and document required training to gain proficiency for all assigned job tasks. Accurately and contemporaneously document all actions performed per GDP standards. Assist with classified and non-classified area cleaning and maintenance as required. Perform visual inspection, labeling, and additional support tasks as required. Make recommendations for process improvements. Possess the ability to master multiple processes across different areas. Recognize and respond appropriately to equipment/documentation issues and deviations; obtain appropriate clarification and guidance from leadership before proceeding. Maintain a quality focused, “Right First Time”, attitude. Arrive for work on-time, prepared to work in the classified environment for the majority of each shift. Operate with Integrity by maintaining high ethical standards. Treat all employees with trust, respect, and professionalism. Speak up and hold others accountable for high integrity by providing constructive feedback. Take accountability for individual and team mistakes and participate in related corrective actions. Ensure patient safety by understanding you and your team's impact on product quality. Excel within a diverse and high performing team. Remain open to new ideas and perspectives, communicate across shifts as required, and comply with site process to create a safe work environment. Demonstrate a passion to perform by meeting personal and departmental goals. Self-driven and self-accountable, performs required tasks, and progresses on qualifications within reasonable timelines. Demonstrate innovation abilities by identifying and speaking up about viable options for improvements and exploring and creating a path for implementation. High School Diploma or equivalent. Must pass a drug test. Must speak, write, and read English. Must be a team player. Must have excellent attention to detail. Prior Sterile Compounding and Pharmaceutical Industry experience. Prior experience operating manufacturing equipment/machinery. Knowledge of FDA guidelines, cGMP, and GDP. Willingness to participate in training and gain other certifications as needed. Knowledge of basic arithmetic and chemistry calculations. Ability to work in a fast-paced environment with dynamic priorities and demands. Excellent written and verbal communication skills. Desire to expand knowledge and grow with the company. Leadership ability.

Company Information You Matter to Cambrex. Cambrex is a leading global contract development and manufacturing organization (CDMO) that provides drug substance, drug product, and analytical services across the entire drug lifecycle. With more than 40 years of experience and a growing team of over 2,000 professionals servicing global clients, Cambrex is a trusted partner in branded and generic markets for API and dosage form development and manufacturing. Your Work Matters. At Cambrex, we strive to build a culture where all colleagues have the opportunity to: engage in work that matters to our customers and the patients they serve learn new skills and enjoy new experiences in an engaging and safe environment strengthen connections with coworkers and the community We're committed to attracting and nurturing a passionate team of valued professionals in our fast-paced and growing company. We offer a competitive benefits package that includes healthcare, life insurance, planning for retirement, and more! Your Future Matters. Known for our customer-focused scientific and manufacturing excellence, as well as our strong commitment to quality and safety, we offer a range of career and growth opportunities across our global network of locations. Together with our customers, we aim to improve the quality of life for patients around the world. Start a career where You Matter by applying today! Job Overview The Data Review Scientist will be responsible for reviewing laboratory data and supporting documentation to ensure that they are compliant with SOPs, and compendial and CGMP requirements. This individual must have knowledge of instrument theory in order to thoroughly vet and review data and draw conclusions based on collected data. Responsibilities Reviews raw technical data provided by technicians, chemists and laboratory supervision to ensure accuracy, completeness and correct scientific conclusions have been drawn. Data may include Analytical Records, notebooks, logbooks, spectra, chromatograms, other instrument output and any other information supporting Analytical Records. Identifies data inaccuracies, incomplete inferences and works directly with laboratory staff to provide guidance and direction on the correction of laboratory data packages. Verifies and ensures that conclusions drawn on laboratory data are sound and accurate and representative of materials under examination. Maintains and manages cGMP and controlled substance systems in all QC/PSG labs at defined levels of compliance in accordance with site approved procedures and protocols. Maintains open communication within and across departments to ensure timely delivery and approval of laboratory documents. Works alternative schedules to support output and data review of laboratories based on business need. All employees are required to adhere to DEA, EPA, FDA and cGMP regulations as they relate to the operation of the Company; and to adhere to all company safety rules and procedures. All employees are expected to report to work regularly and promptly. Other duties relating to departmental mission, not specifically detailed in this section may be assigned. Qualifications/Skills Strong chemistry knowledge with proven ability to handle various project loads is beneficial. Education, Experience & Licensing Requirements Bachelor's degree in chemistry with three years' experience in a pharmaceutical and cGMP environment highly preferred. Experience in a laboratory environment highly preferred. Knowledge of analytical instrumentation (GC, HPLC, FTIR, UV-VIS, etc. ) required. Cambrex Charles City offers an extraordinary opportunity, a competitive salary, and an exceptional benefits package including medical, dental, vision care and prescription, life, LTD, STD; 401(k) with employer match; tuition reimbursement; and the 'Arthur I. Mendolia Scholarship Program. ' Relocation assistance will be offered for this position. Cambrex is an Equal Opportunity / Affirmative Action employer and will consider all qualified applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status. #LI-RD1 All requirements are subject to possible modifications to reasonably accommodate individuals with disabilities. Bachelor's degree in chemistry with three years' experience in a pharmaceutical and cGMP environment highly preferred. Experience in a laboratory environment highly preferred. Knowledge of analytical instrumentation (GC, HPLC, FTIR, UV-VIS, etc. ) required. Cambrex Charles City offers an extraordinary opportunity, a competitive salary, and an exceptional benefits package including medical, dental, vision care and prescription, life, LTD, STD; 401(k) with employer match; tuition reimbursement; and the 'Arthur I. Mendolia Scholarship Program. ' Relocation assistance will be offered for this position. Cambrex is an Equal Opportunity / Affirmative Action employer and will consider all qualified applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status. #LI-RD1Reviews raw technical data provided by technicians, chemists and laboratory supervision to ensure accuracy, completeness and correct scientific conclusions have been drawn. Data may include Analytical Records, notebooks, logbooks, spectra, chromatograms, other instrument output and any other information supporting Analytical Records. Identifies data inaccuracies, incomplete inferences and works directly with laboratory staff to provide guidance and direction on the correction of laboratory data packages. Verifies and ensures that conclusions drawn on laboratory data are sound and accurate and representative of materials under examination. Maintains and manages cGMP and controlled substance systems in all QC/PSG labs at defined levels of compliance in accordance with site approved procedures and protocols. Maintains open communication within and across departments to ensure timely delivery and approval of laboratory documents. Works alternative schedules to support output and data review of laboratories based on business need. All employees are required to adhere to DEA, EPA, FDA and cGMP regulations as they relate to the operation of the Company; and to adhere to all company safety rules and procedures. All employees are expected to report to work regularly and promptly. Other duties relating to departmental mission, not specifically detailed in this section may be assigned.