Quality Assurance Associate jobs at Dr. Reddy's Lab

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. Organization Overview: Lilly is entering an exciting period of growth and we are committed to delivering innovative medicines to patients around the world. Lilly is investing over $1 billion to create a new state-of-the-art manufacturing site, in Concord, North Carolina. The brand-new facility will utilize the latest technology to increase the company's manufacturing capacity in parenteral (injectable) medications, device assembly and packaging operations. This is an exciting once-in-a-lifetime opportunity to help build and operate a new site. The Lilly Concord site will be built using the latest high-tech equipment, advanced highly integrated and automated manufacturing systems, and have a focus on minimizing the impact to our environment. This is an opportunity you don't want to miss! Job Responsibilities: The Quality Assurance Batch Disposition Team assures patients worldwide of safe and efficacious drug and device products, through effective quality oversight of site activities. The QA Batch Disposition is responsible for final disposition of Semi-Finished and/or Finished drug combination products. The QA position is essential for ensuring GMP compliance in the qualification, validation, control strategy and startup of operations to ensure regulatory approval of the facility. Electronic batch records with high integration and focus on data integrity will be utilized to confirm manufacturing production. * Support the site in the development and execution of the site readiness plan with focus on supporting development of the site e-release process and startup of new systems * Performs final batch disposition of semi-finished and/or finished drug product and combination product batches, to ensure high quality medicine (GMP Compliance) is released to market in a timely manner * Effectively own/review/approve GMP documents to ensure quality attributes are met (i.e.: Deviations, procedures, protocols, specifications, and change controls) * Additional job duties as required Basic Requirements: * Bachelor's degree in STEM * Experience working in the pharmaceutical or medical device industry in QA roles * Previous batch disposition experience * Ability to make technical decisions, provide guidance to the site * Proficiency with applicable computer systems * Demonstrated strong oral and written communication skills * Demonstrated interpersonal skills and the ability to work as a team * Root cause analysis/troubleshooting skills * Demonstrated attention to detail and ability to maintain quality systems * Previous regulatory inspection readiness and inspection execution experience * Ability to travel up to 10% for meetings and coordination with global or existing manufacturing sites * Responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate and Site Goals * Qualified candidates must be legally authorized to be employed in the United States. Lilly does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for employment positions on the B or S paths or at levels M1-M2 or R1-R4. Additional Skills/Preferences: * Ability to work 8-hour days - Wednesday through Sunday Day Shift (not eligible for remote work) * Ability to work overtime and be on-call as required * Proven ability to work independently or as part of a Team to resolve an issue * Previous experience with Event and Change Management process * Proficiency with SAP, MES, and Trackwise * Previous experience with device and parenteral product materials Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (******************************************************** for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response. Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups. Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $65,250 - $169,400 Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. #WeAreLilly

Quality Assurance (QA) Associate I, Manufacturing Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life-cycle supply. With time-tested experience in development sciences, delivery technologies, and multi-modality manufacturing, Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually. Catalent Pharma Solutions in San Diego is a premier pharmaceutical chemistry development and manufacturing organization supporting the pharmaceutical and biotechnology industries. We focus on bringing client drug compounds from discovery to the clinic with services that include analytical development, pre-formulation testing, formulation development, GMP (Good Manufacturing Practices) manufacturing and stability storage and testing as well as Clinical Supply Services. At Catalent San Diego, we recruit and develop exceptional individuals with a passion for science and determination to excel. We offer a technically challenging and stimulating environment and the opportunity to learn from the best. Catalent Pharma Solutions in San Diego is currently hiring a Quality Assurance Associate I in our QA Manufacturing group. A QA Associate I must be familiar with applicable GMPs. This individual will be responsible for evaluating the compliance of documents such as batch records, equipment records, environmental monitoring records, etc. with supervision. This individual will function as a primary role within the QA department and must demonstrate excellent communication, critical thinking, and organizational skills. This is a full-time hourly position on 1st shift Monday-Friday. Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer, and Catalent employee. The Role: * Reviews and dispositions production batch records for product release. Determines if records are compliant with internal and cGMP (Good Manufacturing Practices) regulations * Liaison between Manufacturing and QA for executed Batch Record Review and flow of documents * Liaison between QA and client and effectively communicates with clients in regards to Executed Batch Records (EBR) and review status * Tracks status of Executed Batch Records and maintains established deadlines for completion of review and corrections * Reviews and approves GMP product labels * Support GMP manufacturing activities including release of GMP materials, shipment verification and performance of production audits in a Class 100,000 environment, maintenance of clinical trial material inventory logs * Other duties as assigned The Candidate: * High school diploma/GED is required, Bachelor's degree desirable * Experience is preferred in GXP manufacturing environment or similar * Candidate must also be highly detail-oriented and organized, able to work both independently and as a team player with a positive attitude * Physical requirements: must be able to lift up to 50lbs and walk, stand, or sit for extended periods of time Pay: * The annual pay range for this position in California is $55,000 - $65,000 annually. The final salary offered to a successful candidate may vary, and will be dependent on several factors that may include but are not limited to: the type and length of experience within the job, type and length of experience within the industry, skillset, education, business needs, etc. Catalent is a multi-state employer, and this salary range may not reflect positions that work in other states. Why you should join Catalent: * Awesome employee activities: Movie Day, Monthly Birthday Celebrations, Friday Bagel Breakfast, On-site Fitness Center with machines, on-site yoga and HIIT classes, Sponsored Sports Teams, and several other company-sponsored events that encourages positive employee comradery, which contributes to effectively building positive employee relationships, overall creating a positive work environment. * Environmentally friendly green initiatives with on-site practices as well as regularly participating in Beach Clean-up activities for community engagement. * Defined career path and annual performance review and feedback process. Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives. * Several Employee Resource Groups focusing on Diversity and Inclusion. * Competitive salary with bonus potential. Generous 401K match and Paid Time Off accrual. Medical, dental and vision benefits effective day one of employment. * 152 hours of PTO + 10 paid holidays. * Positive and fast-paced working environment focusing on continually improving processes to remain innovative and dynamic. * Tuition Reimbursement - Let us help you finish your degree or earn a new one! * WellHub program to promote overall physical wellness. * Perkspot - offers exclusive or private discounts from approximately 900+ merchants in a wide array of categories. Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference. personal initiative. dynamic pace. meaningful work. Visit Catalent Careers to explore career opportunities. Catalent is an Equal Opportunity Employer, including disability and veterans. If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to DisabilityAccommodations@catalent.com. This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process. Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you. Important Security Notice to U.S. Job Seekers: Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond- it is a fraudulent request. Please forward such requests to ***************** for us to investigate with local authorities. California Job Seekers can find our California Job Applicant Notice HERE.

**Quality Assurance (QA) Associate I, Manufacturing** Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life-cycle supply. With time-tested experience in development sciences, delivery technologies, and multi-modality manufacturing, Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually. Catalent Pharma Solutions in San Diego is a premier pharmaceutical chemistry development and manufacturing organization supporting the pharmaceutical and biotechnology industries. We focus on bringing client drug compounds from discovery to the clinic with services that include analytical development, pre-formulation testing, formulation development, GMP (Good Manufacturing Practices) manufacturing and stability storage and testing as well as Clinical Supply Services. At Catalent San Diego, we recruit and develop exceptional individuals with a passion for science and determination to excel. We offer a technically challenging and stimulating environment and the opportunity to learn from the best. Catalent Pharma Solutions in San Diego is currently hiring a Quality Assurance Associate I in our QA Manufacturing group. A QA Associate I must be familiar with applicable GMPs. This individual will be responsible for evaluating the compliance of documents such as batch records, equipment records, environmental monitoring records, etc. with supervision. This individual will function as a primary role within the QA department and must demonstrate excellent communication, critical thinking, and organizational skills. **This is a full-time hourly position on 1st shift Monday-Friday.** **Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer, and Catalent employee.** **The Role:** + Reviews and dispositions production batch records for product release. Determines if records are compliant with internal and cGMP (Good Manufacturing Practices) regulations + Liaison between Manufacturing and QA for executed Batch Record Review and flow of documents + Liaison between QA and client and effectively communicates with clients in regards to Executed Batch Records (EBR) and review status + Tracks status of Executed Batch Records and maintains established deadlines for completion of review and corrections + Reviews and approves GMP product labels + Support GMP manufacturing activities including release of GMP materials, shipment verification and performance of production audits in a Class 100,000 environment, maintenance of clinical trial material inventory logs + Other duties as assigned **The Candidate:** + High school diploma/GED is required, Bachelor's degree desirable + Experience is preferred in GXP manufacturing environment or similar + Candidate must also be highly detail-oriented and organized, able to work both independently and as a team player with a positive attitude + **Physical requirements:** must be able to lift up to 50lbs and walk, stand, or sit for extended periods of time **Pay:** + The annual pay range for this position in California is $55,000 - $65,000 annually. The final salary offered to a successful candidate may vary, and will be dependent on several factors that may include but are not limited to: the type and length of experience within the job, type and length of experience within the industry, skillset, education, business needs, etc. Catalent is a multi-state employer, and this salary range may not reflect positions that work in other states. **Why you should join Catalent:** + Awesome employee activities: Movie Day, Monthly Birthday Celebrations, Friday Bagel Breakfast, On-site Fitness Center with machines, on-site yoga and HIIT classes, Sponsored Sports Teams, and several other company-sponsored events that encourages positive employee comradery, which contributes to effectively building positive employee relationships, overall creating a positive work environment. + Environmentally friendly green initiatives with on-site practices as well as regularly participating in Beach Clean-up activities for community engagement. + Defined career path and annual performance review and feedback process. Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives. + Several Employee Resource Groups focusing on Diversity and Inclusion. + Competitive salary with bonus potential. Generous 401K match and Paid Time Off accrual. Medical, dental and vision benefits effective day one of employment. + 152 hours of PTO + 10 paid holidays. + Positive and fast-paced working environment focusing on continually improving processes to remain innovative and dynamic. + Tuition Reimbursement - Let us help you finish your degree or earn a new one! + WellHub program to promote overall physical wellness. + Perkspot - offers exclusive or private discounts from approximately 900+ merchants in a wide array of categories. **Catalent offers rewarding opportunities to further your career!** Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference. personal initiative. dynamic pace. meaningful work. Visit Catalent Careers (*********************************** to explore career opportunities. Catalent is an Equal Opportunity Employer, including disability and veterans. If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to DisabilityAccommodations@catalent.com . This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process. Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you. Important Security Notice to U.S. Job Seekers: Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond- it is a fraudulent request. Please forward such requests to ***************** for us to investigate with local authorities. California Job Seekers can find our California Job Applicant Notice HERE (*************************************************************************************************************************** .

Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life-cycle supply. With time-tested experience in development sciences, delivery technologies, and multi-modality manufacturing, Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually. Catalent's Kansas City facility is home to our Oral & Specialty Drug Delivery, Biologics Analytical Services and Clinical Supply Services businesses. The site provides a range of integrated services for oral solid dosage forms, from formulation development and analytical testing to clinical and commercial-scale manufacture. The Kansas City facility is a Center-of-Excellence for our Biologics Analytical Services business. Our talented team has over 25 years of experience providing analytical services for stand-alone and integrated biologics projects. Catalent Pharma Solutions in Kansas City, MO is hiring Associate II, Quality Assurance. The Kansas City Clinical and Specialty Services (CSS) Quality Associate II supports clinical trial projects, ensuring all work is performed in compliance with regulatory requirements, good manufacturing practices (cGMP) and standard operating procedures (SOPs). They are responsible for implementing and maintaining quality assurance processes throughout the product lifecycle. This involves ensuring that all documentation is accurate, up-to-date, and properly maintained in accordance with regulatory requirements. This is a full-time, onsite position. This is a 1st shift position. (M-F 7am-3:30pm) Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer, and Catalent employee. The Role: * Create Certificate of Analysis * Inspect bulk drug and packaged finished product * Perform Component Inspection-primary/secondary * Execute Cleaning Procedures * Able to interpret and comply with specifications * Component Release Packets * Reclass Approvals * Proficient in JD Edwards (IMS) * Pre-Batch Record Review * Post-Batch Record Review * Post Packaging Study Release The Candidate: * High School diploma or GED * 1-3 years packaging experience or related industry experience, preferred * Receives instruction, guidance and direction from others * Uses existing procedures to solve routine problems * Proactive to address work issues at the individual level * Ability to follow a variety of instructions furnished in written, oral, diagram, or schedule form * Mathematical and scientific reasoning ability * Sufficient skills and knowledge in the use of computers and associated computer technology Why you should join Catalent: * Defined career path and annual performance review and feedback process * Diverse, inclusive culture * Positive working environment focusing on continually improving processes to remain innovative * Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives * 152 hours of PTO + 8 paid holidays * Several Employee Resource Groups focusing on D&I * Dynamic, fast-paced work environment * Community engagement and green initiatives * Generous 401K match * Medical, dental and vision benefits effective day one of employment * Tuition Reimbursement - Let us help you finish your degree or start a new degree! * WellHub- program to promote overall physical wellness * Perkspot - offers exclusive or private discounts from approximately 900+ merchants in a wide array of categories Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference. personal initiative. dynamic pace. meaningful work. Visit Catalent Careers to explore career opportunities. Catalent is an Equal Opportunity Employer, including disability and veterans. If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to DisabilityAccommodations@catalent.com. This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process. Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you. Important Security Notice to U.S. Job Seekers: Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond- it is a fraudulent request. Please forward such requests to ***************** for us to investigate with local authorities. California Job Seekers can find our California Job Applicant Notice HERE.

Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life-cycle supply. With time-tested experience in development sciences, delivery technologies, and multi-modality manufacturing, Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually. Catalent's Kansas City facility is home to our Oral & Specialty Drug Delivery, Biologics Analytical Services and Clinical Supply Services businesses. The site provides a range of integrated services for oral solid dosage forms, from formulation development and analytical testing to clinical and commercial-scale manufacture. The Kansas City facility is a Center-of-Excellence for our Biologics Analytical Services business. Our talented team has over 25 years of experience providing analytical services for stand-alone and integrated biologics projects. **Catalent Pharma Solutions in Kansas City, MO is hiring** Associate II, Quality Assurance **.** The Kansas City Clinical and Specialty Services (CSS) Quality Associate II supports clinical trial projects, ensuring all work is performed in compliance with regulatory requirements, good manufacturing practices (cGMP) and standard operating procedures (SOPs). They are responsible for implementing and maintaining quality assurance processes throughout the product lifecycle. This involves ensuring that all documentation is accurate, up-to-date, and properly maintained in accordance with regulatory requirements. **This is a full-time, onsite position. This is a 1st shift position. (M-F 7am-3:30pm)** **Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer, and Catalent employee.** **The Role:** + Create Certificate of Analysis + Inspect bulk drug and packaged finished product + Perform Component Inspection-primary/secondary + Execute Cleaning Procedures + Able to interpret and comply with specifications + Component Release Packets + Reclass Approvals + Proficient in JD Edwards (IMS) + Pre-Batch Record Review + Post-Batch Record Review + Post Packaging Study Release **The Candidate** : + High School diploma or GED + 1-3 years packaging experience or related industry experience, preferred + Receives instruction, guidance and direction from others + Uses existing procedures to solve routine problems + Proactive to address work issues at the individual level + Ability to follow a variety of instructions furnished in written, oral, diagram, or schedule form + Mathematical and scientific reasoning ability + Sufficient skills and knowledge in the use of computers and associated computer technology **Why you should join Catalent:** + Defined career path and annual performance review and feedback process + Diverse, inclusive culture + Positive working environment focusing on continually improving processes to remain innovative + Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives + 152 hours of PTO + 8 paid holidays + Several Employee Resource Groups focusing on D&I + Dynamic, fast-paced work environment + Community engagement and green initiatives + Generous 401K match + Medical, dental and vision benefits effective day one of employment + Tuition Reimbursement - Let us help you finish your degree or start a new degree! + WellHub- program to promote overall physical wellness + Perkspot - offers exclusive or private discounts from approximately 900+ merchants in a wide array of categories **Catalent offers rewarding opportunities to further your career!** Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference. personal initiative. dynamic pace. meaningful work. Visit Catalent Careers (*********************************** to explore career opportunities. Catalent is an Equal Opportunity Employer, including disability and veterans. If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to DisabilityAccommodations@catalent.com . This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process. Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you. Important Security Notice to U.S. Job Seekers: Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond- it is a fraudulent request. Please forward such requests to ***************** for us to investigate with local authorities. California Job Seekers can find our California Job Applicant Notice HERE (*************************************************************************************************************************** .

As a QA Specialist, you will work on projects related to proprietary implants, instrumentation, and design automation systems to enable personalized surgery. The Quality Assurance department encompasses activities related to Documentation Control, Change Control, Corrective Action and Preventive Action, eQMS Administration, Field Actions, Internal Audits and Third-Pary Audits, and Quality Metrics. In this capacity, the QA Specialist will work with a significant degree of independence and self-direction to ensure the establishment, implementation, and verification of companywide QMS systems for regulatory compliance. Responsibilities Plan agenda and lead CAPA meetings (present requests, take meeting minutes, and take actions per Boards direction). Manage CAPAs in electronic system (document due dates, activities, and promote through workflows and approvals). Plan and lead root cause analysis meetings and develop corrective action plans with content subject matter experts (SME). Implement corrective action plans with support of SME and monitor and verify CAPA effectiveness. Assess previous audit findings to establish priorities and strategies. Plan annual audit schedule, determine and assign SMEs to audits, establish audit content, and allocate time. Prepare audit plans, perform audits (assess objective evidence to determine conformity to requirements, including ranking the levels of nonconformance findings), and complete audit reports. Support customer and regulatory audits, including audit response follow-up. Specifically, reserve meeting space, coordinate SME participation per audit agenda, documenting the audit, document and record retrieval and preparation, and submission of audit response. Stay up to date on industry standards and regulatory changes. Interpret standards and regulatory rules or rule changes, perform gap assessments between corporate procedures and applicable standards and regulatory rules, and implement them through the release or revision of corporate procedures. Actively seek and lead projects to streamline processes, procedures, and/or practices. Supports Field Action, which includes managing customer notification, product documentation, and follow-up activities to support closure of Field Action/Recalls. Monitor, gather, analyze, and trend key quality and compliance performance indicators utilizing pivot tables, charts, and graphs. Prepare presentations of trend data for quarterly trend and management review meetings. Coordinate quarterly trend and management review (schedule, document notes and attendance, and documentation archiving). Qualifications Lead Auditor certified (ISO 13485) preferred Training in or good working knowledge of 21CFR820, ISO 13485, MDSAP, and ISO 14971 Training in or good working knowledge of root cause analysis tools Advanced Excel Skills (VLOOKUP, Pivot Tables, forms, data analysis, etc) Advanced PowerPoint skills (i.e. Excel chart linking and template design) Effective technical writing and verbal communication skills. Experience Minimum three years in the medical device industry Minimum three years of experience in quality system management/quality assurance o CAPA (Corrective Action Preventive Action) administration; o Interpreting and implementing regulatory and standard requirements; o Reviewing system changes for continued compliance; o Monitoring, gathering, analyzing, and trending key quality and compliance performance indicators; and o Third party audit coordination Minimum two years experience as lead auditor Proven ability to support and implement quality systems and quality improvements (i.e. Upgrade from ISO 13485 2003 to ISO 13485 2016, or implementation of MDSAP). Increasing responsibilities whether within the same organization or as a progression within career path. Equal Opportunity Employer Carlsmed is an equal opportunity employer. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status. Carlsmed is committed to providing reasonable accommodations for candidates with disabilities in our recruiting process. If you need any assistance or accommodations due to a disability, please let us know. Compensation We are pleased to provide a competitive salary and benefits. Our benefits reflect our investment in the overall health and well-being of our employees and their families. including paying 100% of monthly healthcare, dental & vision insurance premiums, a 401(k) plan with employer matching and unlimited PTO. The expected starting pay range is: $80,000 to $90,000 annually. Compensation may vary based on related skills, experience, and relevant key attributes.

As a QA Specialist, you will work on projects related to proprietary implants, instrumentation, and design automation systems to enable personalized surgery. The Quality Assurance department encompasses activities related to Documentation Control, Change Control, Corrective Action and Preventive Action, eQMS Administration, Field Actions, Internal Audits and Third-Pary Audits, and Quality Metrics. In this capacity, the QA Specialist will work with a significant degree of independence and self-direction to ensure the establishment, implementation, and verification of companywide QMS systems for regulatory compliance. Responsibilities * Plan agenda and lead CAPA meetings (present requests, take meeting minutes, and take actions per Board's direction). * Manage CAPAs in electronic system (document due dates, activities, and promote through workflows and approvals). * Plan and lead root cause analysis meetings and develop corrective action plans with content subject matter experts (SME). Implement corrective action plans with support of SME and monitor and verify CAPA effectiveness. * Assess previous audit findings to establish priorities and strategies. Plan annual audit schedule, determine and assign SMEs to audits, establish audit content, and allocate time. * Prepare audit plans, perform audits (assess objective evidence to determine conformity to requirements, including ranking the levels of nonconformance findings), and complete audit reports. * Support customer and regulatory audits, including audit response follow-up. Specifically, reserve meeting space, coordinate SME participation per audit agenda, documenting the audit, document and record retrieval and preparation, and submission of audit response. * Stay up to date on industry standards and regulatory changes. Interpret standards and regulatory rules or rule changes, perform gap assessments between corporate procedures and applicable standards and regulatory rules, and implement them through the release or revision of corporate procedures. * Actively seek and lead projects to streamline processes, procedures, and/or practices. * Supports Field Action, which includes managing customer notification, product documentation, and follow-up activities to support closure of Field Action/Recalls. * Monitor, gather, analyze, and trend key quality and compliance performance indicators utilizing pivot tables, charts, and graphs. * Prepare presentations of trend data for quarterly trend and management review meetings. Coordinate quarterly trend and management review (schedule, document notes and attendance, and documentation archiving). Qualifications * Lead Auditor certified (ISO 13485) preferred * Training in or good working knowledge of 21CFR820, ISO 13485, MDSAP, and ISO 14971 * Training in or good working knowledge of root cause analysis tools * Advanced Excel Skills (VLOOKUP, Pivot Tables, forms, data analysis, etc…) * Advanced PowerPoint skills (i.e. Excel chart linking and template design) * Effective technical writing and verbal communication skills. Experience * Minimum three years in the medical device industry * Minimum three years of experience in quality system management/quality assurance o CAPA (Corrective Action Preventive Action) administration; o Interpreting and implementing regulatory and standard requirements; o Reviewing system changes for continued compliance; o Monitoring, gathering, analyzing, and trending key quality and compliance performance indicators; and o Third party audit coordination * Minimum two years experience as lead auditor * Proven ability to support and implement quality systems and quality improvements (i.e. Upgrade from ISO 13485 2003 to ISO 13485 2016, or implementation of MDSAP). * Increasing responsibilities whether within the same organization or as a progression within career path. Equal Opportunity Employer Carlsmed is an equal opportunity employer. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status. Carlsmed is committed to providing reasonable accommodations for candidates with disabilities in our recruiting process. If you need any assistance or accommodations due to a disability, please let us know. Compensation We are pleased to provide a competitive salary and benefits. Our benefits reflect our investment in the overall health and well-being of our employees and their families. including paying 100% of monthly healthcare, dental & vision insurance premiums, a 401(k) plan with employer matching and unlimited PTO. The expected starting pay range is: $80,000 to $90,000 annually. Compensation may vary based on related skills, experience, and relevant key attributes.

Job title: QA Specialist Department Division/Location: FLSA Status Quality Assurance Ontario, CA , USA Non-Exempt Position Reports To: Effective Date of Job description: Alternate Lourdes Gonzalez 7-16-2020 Lourdes Gonzalez POSITION SUMMARY A Quality Assurance Specialist performs any kind of testing and validation that will ensure food safety. The tasks will include support project efforts. This position will involves constant improvement of the operations processes. It will also operate as a member of the cross-departmental teams and projects if necessary. EDUCATION Elementary/Some High School High School/GED Post Secondary Education Bachelor's Degree/Master's Required Preferred Required Preferred Required Preferred Required Preferred Certifications: SQF Practitioner HACCP Required Preferred Required Preferred Required Preferred EXPERIENCE Years: 2-5 Special Focus of: Food Manufacturing SKILLS REQUIRED Detail-oriented individuals with analytical minds and strong communication skills. This position should demonstrate the following: Technical Skills - Understanding quality assurance as well as production technologies and systems is crucial in this role Computer Skills - Knowledge of Microsoft Office Suite programs, such as Word and PowerPoint, is necessary for QA specialists to produce documents, reports, and presentations Commercial Awareness - These specialists should be experts in industry standards impacting inspection and quality control techniques and procedures Communication Skills - Strong oral and written communication skills for making presentations and producing testing and quality assurance reports is necessary. Attention to Detail - The ability to detect issues from among many products and review every aspect of production operation calls for a keen eye for details. Team-Oriented - QA specialists work closely with quality control managers, production workers, quality engineers, inspectors, and other personnel Analytical Skills - Analyzing production processes and applying this skill to the inspection of products is central to this role Time Management - produce results in a timely manner. PRIMARY RESPONSABILITIES Deviation Analysis Support the analysis and corrective action of deviation that may come from process deviation, complaints, holds, etc. using root cause analysis techniques. Product and Raw Material Testing Support qualification of new product, raw materials and suppliers. Perform inspection on raw material and/or finished goods to check for defects and other product parameters to validate Plant internal programs and processes. Equipment Commissioning Support all tests related to new equipment commissioning and prepare report for further review. Process Validation Support validation plans for Plant's processes. Analyze validation test data to determine whether systems or processes have met validation criteria or to identify root causes of production problems. Prepare detailed reports based on results of validation and qualification tests. Collect and analyze production samples to support process validations. Analyze quality control test results and provide feedback and interpretation to production management or staff. Performs audits of the effectiveness of development processes and products and recommends improvements as necessary Work with upper Management to identify performance improvement opportunities by analyzing quality data and documentation. Documenting/Recording Information Entering data in the QA drive to maintaining information in electronic form to facilitate data analysis. Operations Procedures Support the development of new procedures for Operations that will improvements and/or minimize errors and defects in product. Support operations processes standardization. Continuous Improvement Download quality and production information form Aptean system and perform monthly reviews and targets. Support and/or develop QA test trends and as need. Training Support Plant training program by creating training material for Quality and Production and consequently employee training. Safety Participate in, and support all safety program elements, directed towards meeting the plant's TIR (Total Incident Rate) goal established each year. This includes safety training, inspections, incident investigations, incentive programs, and any other safety-related activities. Comply with all company policies and procedures including safety rules. Food Safety and Quality Adheres to all Food Safety/Quality SOP's Communicates any known or suspected Food Safety/ Quality issues to the Production Manager or Supervisor, Q.A. Department or Management. Attends Food Safety/Quality training sessions.

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 works with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate. Eurofins is the global leader in food, environment, pharmaceutical and cosmetic product testing and in agroscience Contract Research Organisation services. Eurofins 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. The Group also has a rapidly developing presence in highly specialised and molecular clinical diagnostic testing and in-vitro diagnostic products. In over just 30 years, Eurofins has grown from one laboratory in Nantes, France to 55,000 staff across a decentralised and entrepreneurial network of 900 laboratories in over 50 countries. Eurofins offers a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products. Job Description The Laboratory Quality Assurance (QA) Coordinator is responsible for ensuring that DPT's quality system is well-documented, traceable, and compliant. This role focuses specifically on regulatory readiness documentation and inspection support. Role is critical in tracking, organizing, and executing the administrative an procedural backbone of the laboratories' quality program.. This position ensures compliance with federal, state, and local regulations (e.g., CLIA, CAP, ISO, FDA) and drives continuous quality improvement initiatives. The QA Coordinator develops and maintains policies, conducts audits, manages documentation, and trains staff on quality procedures. Key Responsibilities: * Quality Management System (QMS) Oversight: Develops, implements, and maintains the laboratory's comprehensive quality management system, including the Quality Manual, policies, and procedures. * Regulatory Compliance: Monitor and ensure continuous compliance with all applicable accreditation and regulatory standards (e.g., CAP, CLIA, ISO 15189, GxP, FDA). * Audits and Inspections: Coordinate and participate in internal and external audits/inspections, manage the response to findings, and implement corrective and preventive actions (CAPAs). Assist in preparing audit schedules and checklists. Track corrective actions and verify closures. Organize and maintain documentation needed for audits and inspections. Assist in preparing materials and responses for regulatory and accrediting inspections and client audits. * Documentation and Record Control: Oversees the documentation control system.. Logs and tracks nonconformances, deviations and incident reports. Ensures completeness and accuracy of quality records. * Change Management Support: Log and monitor change requests. Track approval workflows and implementation timelines. Assist in collecting / reminding of required objective evidence for activity / file closure. Ensure related documentation is complete before closure. * Training and Education: Develop and conduct training sessions for staff on quality standards, new procedures, and best practices to promote a quality culture. Send reminders for upcoming and overdue training, as applicable. * Event and Risk Management: Assist in investigation of non-conformances, errors, and incidents; perform root cause analysis; and determine corrective actions to mitigate future risks. Ensure timeliness of all activities to meet regulatory expectations. Develop tools to assist with tracking activities / actions. * Communication and Coordination: Schedule QA Meetings and take meeting minutes. Communicate deadlines, updates and quality-related notifications. Serve as liaison between QA and other departments. * Supplier Qualification Program: Develop schedule to ensure Approved Supplier List (ASL) is kept up-to-date. Ensure qualification / re-qualification documentation is current and filed appropriately. Participate in vendor-related SCAR issuance, receipt of responses and assuring documentation meets DPT's requirements. Qualifications Required Qualifications and Skills: * Education: Bachelor's degree, preferably in a chemical, physical, biological science, or Medical Laboratory Science (MLS/MT) from an accredited institution. * Experience: Minimum of 5-7 years of experience in a clinical or analytical laboratory environment, with demonstrated experience in quality assurance or quality control. * Knowledge: Strong knowledge of quality management systems (e.g., ISO, CLIA, CAP) and relevant federal/state regulations. * Skills: * Excellent attention to detail and strong organizational skills. * Strong analytical and problem-solving abilities, with an aptitude for data interpretation and statistical analysis. * Excellent written and verbal communication skills, with the ability to effectively communicate with diverse staff and management. * Proficiency with laboratory information management systems (LIMS) and Microsoft Office Suite. * Ability to work both independently and collaboratively in a fast-paced environment. Preferred Qualifications: * Certification in quality management (e.g., Certified Quality Auditor (CQA) or Six Sigma certification). * Experience with specific laboratory certifications/standards relevant to the lab's specialty (e.g., ASHI, CAP, CLIA,) Additional Information Compensation: * $75,000 - $100,000 Schedule: * Monday - Friday 8:00am-4:30pm What we offer: * 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 Eurofins USA Clinical Diagnostics is a Disabled and Veteran Equal Employment Opportunity employer.

Are you ready to embark on a career where innovation meets excellence? At Jost Chemical Company, we're on a mission to push the boundaries of chemical manufacturing, delivering high-quality products that make a positive impact on global industries. If you're passionate about chemistry, dedicated to precision, and eager to contribute to a company that values both innovation and integrity, explore our exciting job opportunities. Join us in shaping the future of chemical manufacturing at Jost Chemical Company, where your career is more than just a job - it's a journey of growth and achievement. Then, this position is right for you! Founded in 1985, Jost Chemical is a global leader in the manufacture of high purity mineral salts for the nutritional, pharmaceutical and specialty markets. Expansion, growth of capabilities, and investment in people, lab and production equipment have been a part of Jost's company culture for 35 years. To learn more about Jost Chemical please visit ******************** Our offer: * Shift Differential * Medical/Dental/Vision Plan Insurance, Short and Long-Term Disability and Life Insurance first of the month following 60 days. * 401k plan which includes safe-harbor contribution and discretionary match. * Paid Time Off (PTO) Employees eligible first day of employment. * 9 Company Paid Holidays (72 hours) each year. * Uniforms Provided * Foot Protection- annual allowance for all laboratory, maintenance and production employees. * 24-hour access to our free, on-site fitness center. * We provide Individual development, on-the-job training, and development programs designed to enhance your professional growth and development while ensuring you feel valued, inspired and appreciated at work. Jost Chemical is an equal opportunity employer and affirmatively seeks diversity in its workforce. We consider applicants, and make all employment decisions, without regard to race, color, religion, creed, gender, national origin, age, disability, marital or veteran status, or any other legally protected status. We are committed to recruiting and retaining the best talent in the chemical manufacturing industry. The Quality Assurance (QA) Specialist in Pharmaceuticals is responsible for ensuring that all products and processes meet established standards of quality, including reliability, usability, and performance. This role involves developing, implementing, and maintaining quality assurance systems and activities to ensure compliance with regulatory requirements and internal standards. The QA Specialist will work closely with cross-functional teams, including manufacturing, regulatory affairs, and R&D, to support continuous improvement initiatives and ensure product safety and efficacy. Job Responsibilities: * Work in a GMP regulated environment to provide and assist in implementation of quality-related activities. * Provide expertise and guidance in interpreting policies, regulatory guidelines, and regulations to ensure compliance and act as departmental resource for cGMP programs. * Provide QA support and be a primary point of contact for quality systems and other operational systems, provide oversight of systems to ensure compliance with internal policies, procedures, and guidelines. * Review and approve procedures and documents against regulatory and internal requirements to include protocols, technical specifications, raw data, final reports. * Author SOP's, protocols, validation plans and compliance documents for cGMP program. * Author and review validation documentation - such as user requirements, functional requirements, validation plans, IQ/OQ/PQ documentation, risk assessments, test scripts, trace matrix Review. * Review and audit computerized system validation deliverables according to 21 CFR Part 11, Annex 11 and other regulatory requirements. * Oversees qualification of instruments, equipment, facility, clean rooms and computer hardware - software. * Perform periodic reviews for all validations and qualifications. * Follow Good Documentation Practices and Data Integrity requirements to ensure data, documentation, and records are completed and maintained for use by the business and available to support audits or inspections. * Identify and implement continuous improvement efforts for the quality systems to ensure alignment with regulatory regulations/guidance. * Maintain, enforce and improve Food Safety Program/ HACCP/ FSSC 22000 certification. * Performs internal audits, self-inspections in areas including quality control, manufacturing, warehousing, packaging, food safety. Ensures observations are corrected. * Present data during department and cross-functional meetings as needed. * Coordinate and liaise with other departments to facilitate uniform quality standards for the site. * Review and approve Change Control records acting as a subject matter expert, ensuring compliance with internal policies, procedures, and guidelines. * Perform and conduct risk assessments for various GMP topics. * Perform other activities as required based on company needs. * Administrator of Quality Management Software Qualifications: * A Bachelor's Degree is essential, preferably in a relevant scientific field like Chemistry, Biology, Biochemistry, or Microbiology. * Preferred at least 5 years of experience in the biopharmaceutical industry, with progressive involvement in Quality Assurance cGMP experience in the area of Active Pharmaceutical Ingredients (API) manufacturing or related industrial experience. * Exceptional written and verbal communication abilities. * Knowledgeable in instrument, equipment, facility, clean rooms and software qualification - validation. * Experienced in auditing suppliers, analytical contract labs and vendors. * Knowledge of annual product review and stability study protocols per ICH. * High level of knowledge in cGMP guidelines as specified in ICH Q7A. * Working knowledge of 21 CFR Parts 11, 210, and 211 * Experience conducting audits of internal and external operations preferred. * Certification as a Quality Auditor or an equivalent qualification preferred. * Proficiency in computer operations, including experience with SAP and various reporting and data analysis tools such as Word, Excel, Visio, JMP, and Minitab.

About the Company: Nivagen is a global company dedicated to enhancing lives by developing and providing cost-effective generic prescription drugs and over-the-counter products for the North American market. For over a decade, we've remained steadfast in our commitment to core values of excellence, integrity, and respect for people. Our team of professionals collaborates tirelessly to pioneer advancements in manufacturing, distribution, and quality control, ensuring a holistic approach to healthcare. Through vertical integration of the pharmaceutical supply chain, cutting-edge technology, and unwavering dedication to excellence, we continually strive to redefine medication accessibility and affordability. We prioritize our employees' well-being by offering competitive pay, comprehensive benefits, and robust training and development opportunities. By investing in our workforce and fostering a culture of growth and support, we empower our team to drive innovation and make a positive impact in the healthcare industry. At Nivagen, our mission is clear: to make a meaningful difference in people's lives by delivering high-quality, affordable medications while upholding the highest standards of integrity and excellence. Job Location: Nivagen Pharmaceuticals Inc. 3900 Duckhorn Drive, Sacramento, CA 95834 About the Job: Title of the Position: QA Specialist As a Quality Assurance (QA) Specialist, you will play a critical role in ensuring that all products, processes, and documentation meet established quality standards, regulatory requirements, and company policies. Your responsibilities will include maintaining compliance with cGMP, GLP, and other industry regulations, safeguarding product integrity, and supporting continuous improvement initiatives. You will manage Quality Management Systems (QMS), review critical documentation, oversee training programs, and ensure adherence to organizational quality objectives. Responsibilities: Responsible for collecting and analysing information to identify actual and potential product and quality problems, to work with the Site Quality Lead Team to take appropriate and effective corrective and preventive actions, and to verify and validate the effectiveness of CAPA. Leads, mentors, and coaches operations and support personnel on the Change control, deviation management system and CAPA program. To drive complete root cause investigations and ensure assignment of corrective and preventive actions to eliminate the root causes of a detected issue or other undesirable situation to prevent reoccurrence. Create and maintain the CAPA program, through working cross-functionally with all area/function owners to include data sources that identify existing as well as potential problems. Compile and present CAPA program health metrics to the Site Quality Lead Team with proposed actions. Monitor deviation and CAPA performance to ensure investigations and associated CAPA are completed in a timely manner. Act as a site instructor for Change control, Deviation Management and CAPA courses. Coaches lead investigators on technical writing. Authors periodic reviews and acts as Subject Matter Expert for site CAPA and Deviation Management procedures. Supports and initiates deviations, trends, or other technical investigations, as applicable. Engages site personnel in the relationship between the CAPA program and resulting product and process improvement and enhanced product and process understanding. Effective implementation of electronic Quality Management system (eQMS) across organizations. To perform additional duties assigned by the reporting manager. Qualifications: Education/Experience: Bachelor's degree in a relevant field such as Pharmacy, Chemistry, Microbiology, Biotechnology, or a related discipline. Minimum 1-3 years of experience in Quality Assurance or a related field in a regulated industry (pharmaceuticals, biotechnology, or healthcare preferred). Knowledge, Skills, and Abilities: Strong knowledge of cGMP, GLP, and quality standards such as ISO 9001. Proficiency in managing Quality Management Systems (QMS). Familiarity with laboratory instruments and analytical methods. Experience with document control processes and regulatory audits. Excellent attention to detail and strong organizational skills. Effective communication and interpersonal skills for collaboration across departments. Strong analytical and problem-solving abilities. Ability to work independently and as part of a team in a fast-paced environment. Proficient in Microsoft Office Suite (Word, Excel, PowerPoint) and QMS software tools. Requirements: Legally authorized to be employed in the United States Must live or willing to move to Sacramento Metropolitan Region (Approx. 40 miles' radius) Benefits: Pay range $25.0 per hour to annual salary of $70,000 Yearly bonus eligibility Benefits: Nivagen offers a wide variety of benefits and programs to support health and well-being Medical, dental and vision coverage Paid time off plan 401k savings plan Additional Information: Nivagen to afford equal opportunity for employment to all individuals regardless of race, color, age, national origin, physical or mental disability, history of disability, ancestry, citizenship status, political affiliation, religion, gender, transgender, gender identity, marital status, status as a parent, sexual orientation, veteran status, genetic information or other factors prohibited by law, and to prohibit harassment or retaliation based on any of these factors.

Turning Point Community Programs is seeking a Quality Assurance Coordinator for our Transition Support Services (TSS) North program in Chico. Turning Point Community Programs (TPCP) provides integrated, cost-effective mental health services, employment and housing for adults, children and their families that promote recovery, independence and self-sufficiency. We are committed to innovative and high quality services that assist adults and children with psychiatric, emotional and/or developmental disabilities in achieving their goals. Turning Point Community Programs (TPCP) has offered a path to mental health and recovery since 1976. We help people in our community every single day - creating a better space for all types of people in need. Join our mission of offering hope, respect and support to our clients on their journey to mental health and wellness. GENERAL PURPOSE Under the administrative supervision of the Clinical Director, this position is responsible for ensuring that the program remains in compliance with Regional Center guidelines. Assists the Clinical Director in the quality management functioning of the Program. DISTINGUISHING CHARACTERISTICS This is an at-will administrative position within a program. Additionally, this position is responsible for the day-to-day completion of critical paperwork and assisting the Clinical Director. ESSENTIAL DUTIES AND RESPONSIBILITIES - (ILLUSTRATIVE ONLY) The duties listed below are intended only as illustrations of the various types of work that could be performed. The omission of specific statements of duties does not exclude them from the position if the work is similar, related or a logical assignment to this class Completes Diagnosis updates as assigned. Completes MORS/8 Determinants assessments as assigned. Tracks progress notes and provides feedback directly to management team. Tracks assessments due and completion. Works in coordination with the Team Leaders and Clinical Director to ensure that all assessments and client plans are completed in a timely manner. Attends/Conducts Utilization Review meetings when the Clinical Director is not available. Coordinates with Clinical Director to implement recommendations. Responsible for tracking and reviewing results of internal utilization and review. Reviews charts to ensure that they meet state and legal/Regional Center requirements. Assists the Clinical Director and Program Director with developing the Quality Improvement plan and implementing changes. Assist the Clinical Director with filing, organizing and maintaining a record of KETs (Key Event Tracking) and inputting data into charted system. Assist the Clinical Director with filing, organizing and maintaining a record of Risk Management Binder (SIRs). In coordination with the Clinical Director and Program Director, reviews and evaluates customer satisfaction/performance outcome data. Ensures the safety, health, and well-being of the members. Completes paperwork as assigned in a timely manner. Meets the standards set for performance in all aspects of job duties. Provides support to other staff members as needed. Adheres to and upholds the policies and procedures of Turning Point Community Programs. Attends staff meetings unless approval for non-attendance is secured from the Clinical Director or Program Director. Schedule: Monday - Friday, 8:30 am - 5:00 pm Compensation: $26.00 - $27.59 per hour Interested? Join us at our open interviews on Wednesdays from 2-4PM, located at 10850 Gold Center Drive, Suite 325, Rancho Cordova, CA 95670 -or- CLICK HERE TO APPLY NOW!

Eurofins Scientific is a network of independent companies 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 to ensure the products they supply are safe, their ingredients are authentic, and labelling is accurate. Eurofins is dedicated to delivering testing services that contribute to the health and safety of society and the planet, and to its corporate responsibility to protect the environment and ensure diversity, equity, and inclusion across the entire network of Eurofins companies. With over 50 laboratories and more than 40 service centers nationwide, Eurofins Environment Testing provides full-service environmental analysis across all 50 states. Our network supports public and private clients-including DoD, DOE, and municipalities-through robust logistics and continuous investment in people, technology, and infrastructure. We offer comprehensive testing for air, water, soil, sediment, tissue, and waste, covering a wide range of analytes including PFAS, metals, VOCs/SVOCs, dioxins/furans, radiochemicals, and more. Job Description The Quality Assurance (QA) Specialist is responsible for performing internal audits, assisting with external audits, overseeing the maintenance of QC records, certifications, review and revision of Standard Operating Procedures (SOPs), training records, Demonstrations of Capability (DOCs), arranging and managing proficiency testing (PT) samples. Additional responsibilities may include investigating systematic problems within the laboratory, assisting in writing client-facing CARs, and other functions in support of the QA Manager's responsibilities as assigned. Essential Duties and Responsibilities As assigned by the QA Manager, the duties and responsibilities may include all or some of the following items: Conduct group meetings Perform data audits Perform audits for client inquiries, etc. Assist in conducting and responding to external audits conducted by clients and regulatory agencies Review Quality Assurance Project Plans, and technical and QC specifications in contracts and proposals Assist in maintaining laboratory certifications Assist in arranging and manage scheduling, ordering, login, and reporting of PT samples Monitor new regulations and communicate them to the laboratory Review and write SOPs Maintain historical indices of technical records including SOPs, QC records, laboratory data, etc. Assist in and monitor laboratory's compliance with the reference methods, SOPs, and agency-specific requirements Maintain training records, including Demonstrations of Capability (DOCs) for all analysts Assist in identification of systematic problems within laboratory and recommend resolutions for ongoing or recurring nonconformance Track customer complaints and assist in identifying improvements Oversee and review MDL studies Generate control charts, control limits, and update LIMS Perform or arrange for calibration of laboratory support equipment Qualifications Basic Minimum Qualifications (BMQ): 5+ years of direct QA industry experience Intermediate to advanced knowledge of environmental analytical methodologies Knowledge of regulatory requirements, including TNI Computer skills; presentations, organizing MDLs, LIMS, Excel, etc. Clear communication through language and writing Professional demeanor Authorization to work in the United States indefinitely without restriction or sponsorship Professional working proficiency in English is a requirement, including the ability to read, write and speak in English Ability and/or Skills Analytical laboratory techniques Laboratory QA requirements Statistical principles Technical and business writing skills Organizational skills Management skills Problem solving skills Ability to analyze problems and effect solutions Additional Information Compensation range: $26 - $30 per hour depending on qualifications and experience. Position is Full-time Monday - Friday , 9AM - 6PM shift with overtime or weekend work as needed. Eurofins Environment Testing (USA) provides a compensation range for informational purposes, the actual base compensation may vary based upon, but not limited to, relevant experience and skill set, base compensation of internal peers, business sector, and geographic location. As a Eurofins employee, you will become part of a company that has received national recognition as a great place to work. We offer excellent full-time benefits including comprehensive medical coverage, life and disability insurance, 401(k) with company match, paid holidays, paid time off, and dental and vision options. We support your development! Do you feel you don't match 100% of the requirements? Don't hesitate to apply anyway! Eurofins companies are committed to supporting your career development. We embrace diversity! Eurofins network of companies believe in strength and innovation through diversity, being an Equal Opportunity Employer. We prohibit discrimination against employees or applications based on gender identity and/or expression, race, nationality, age, religion, sexual orientation, disability, and everything else that makes employees of Eurofins companies unique. Sustainability matters to us! We are well on our way to achieving our objective of carbon neutrality by 2025, through a combination of emission reduction and compensation initiatives. We encourage our laboratory leaders to make sustainable changes at their local level, and in addition to their initiatives we also count on our dedicated carbon reduction team to help us to achieve this goal! Find out more in our career page: ***************************** Company description: 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 discovery pharmacology, forensics, advanced material sciences and agroscience contract research 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 35 years, Eurofins has grown from one laboratory in Nantes, France to 61,000 staff across a decentralised and entrepreneurial network of ca. 900 laboratories in 61 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 2024, Eurofins generated total revenues of EUR 6.95 billion, and has been among the best performing stocks in Europe over the past 20 years. Eurofins USA Environment Testing is a Disabled and Veteran Equal Employment Opportunity employer.

Eurofins Scientific is a network of independent companies 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 to ensure the products they supply are safe, their ingredients are authentic, and labelling is accurate. Eurofins is dedicated to delivering testing services that contribute to the health and safety of society and the planet, and to its corporate responsibility to protect the environment and ensure diversity, equity, and inclusion across the entire network of Eurofins companies. With over 50 laboratories and more than 40 service centers nationwide, Eurofins Environment Testing provides full-service environmental analysis across all 50 states. Our network supports public and private clients-including DoD, DOE, and municipalities-through robust logistics and continuous investment in people, technology, and infrastructure. We offer comprehensive testing for air, water, soil, sediment, tissue, and waste, covering a wide range of analytes including PFAS, metals, VOCs/SVOCs, dioxins/furans, radiochemicals, and more. Job Description The Quality Assurance (QA) Specialist is responsible for performing internal audits, assisting with external audits, overseeing the maintenance of QC records, certifications, review and revision of Standard Operating Procedures (SOPs), training records, Demonstrations of Capability (DOCs), arranging and managing proficiency testing (PT) samples. Additional responsibilities may include investigating systematic problems within the laboratory, assisting in writing client-facing CARs, and other functions in support of the QA Manager's responsibilities as assigned. Essential Duties and Responsibilities As assigned by the QA Manager, the duties and responsibilities may include all or some of the following items: * Conduct group meetings * Perform data audits * Perform audits for client inquiries, etc. * Assist in conducting and responding to external audits conducted by clients and regulatory agencies * Review Quality Assurance Project Plans, and technical and QC specifications in contracts and proposals * Assist in maintaining laboratory certifications * Assist in arranging and manage scheduling, ordering, login, and reporting of PT samples * Monitor new regulations and communicate them to the laboratory * Review and write SOPs * Maintain historical indices of technical records including SOPs, QC records, laboratory data, etc. * Assist in and monitor laboratory's compliance with the reference methods, SOPs, and agency-specific requirements * Maintain training records, including Demonstrations of Capability (DOCs) for all analysts * Assist in identification of systematic problems within laboratory and recommend resolutions for ongoing or recurring nonconformance * Track customer complaints and assist in identifying improvements * Oversee and review MDL studies * Generate control charts, control limits, and update LIMS * Perform or arrange for calibration of laboratory support equipment Qualifications Basic Minimum Qualifications (BMQ): * 5+ years of direct QA industry experience * Intermediate to advanced knowledge of environmental analytical methodologies * Knowledge of regulatory requirements, including TNI * Computer skills; presentations, organizing MDLs, LIMS, Excel, etc. * Clear communication through language and writing * Professional demeanor * Authorization to work in the United States indefinitely without restriction or sponsorship * Professional working proficiency in English is a requirement, including the ability to read, write and speak in English Ability and/or Skills * Analytical laboratory techniques * Laboratory QA requirements * Statistical principles * Technical and business writing skills * Organizational skills * Management skills * Problem solving skills * Ability to analyze problems and effect solutions Additional Information Compensation range: $26 - $30 per hour depending on qualifications and experience. Position is Full-time Monday - Friday , 9AM - 6PM shift with overtime or weekend work as needed. Eurofins Environment Testing (USA) provides a compensation range for informational purposes, the actual base compensation may vary based upon, but not limited to, relevant experience and skill set, base compensation of internal peers, business sector, and geographic location. As a Eurofins employee, you will become part of a company that has received national recognition as a great place to work. We offer excellent full-time benefits including comprehensive medical coverage, life and disability insurance, 401(k) with company match, paid holidays, paid time off, and dental and vision options. We support your development! Do you feel you don't match 100% of the requirements? Don't hesitate to apply anyway! Eurofins companies are committed to supporting your career development. We embrace diversity! Eurofins network of companies believe in strength and innovation through diversity, being an Equal Opportunity Employer. We prohibit discrimination against employees or applications based on gender identity and/or expression, race, nationality, age, religion, sexual orientation, disability, and everything else that makes employees of Eurofins companies unique. Sustainability matters to us! We are well on our way to achieving our objective of carbon neutrality by 2025, through a combination of emission reduction and compensation initiatives. We encourage our laboratory leaders to make sustainable changes at their local level, and in addition to their initiatives we also count on our dedicated carbon reduction team to help us to achieve this goal! Find out more in our career page: ***************************** Company description: 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 discovery pharmacology, forensics, advanced material sciences and agroscience contract research 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 35 years, Eurofins has grown from one laboratory in Nantes, France to 61,000 staff across a decentralised and entrepreneurial network of ca. 900 laboratories in 61 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 2024, Eurofins generated total revenues of EUR 6.95 billion, and has been among the best performing stocks in Europe over the past 20 years. Eurofins USA Environment Testing is a Disabled and Veteran Equal Employment Opportunity employer.

A primary focus of this role is creating and modifying LIMS test plans to support QC activities while adhering to regulatory and data integrity guidelines. The LIMS Coordinator is responsible for tracking and managing laboratory inventories within the LIMS system and to perform and verify daily verification of laboratory data for accuracy and completeness, ensuring compliance with GxP standards before submission for review. Essential Functions: * Register samples and input relevant test results, instrument data, and laboratory information into the LIMS system as per QC procedures. * Manage laboratory inventories, ensuring timely replenishment and accurate record-keeping within the LIMS system as well as generate and run standard reports from the LIMS system for Laboratory Resource tracking. * Perform and verify daily verification data for accuracy and completeness before submitting it for review. * Create, troubleshoot and modify LIMS Test, worksheets, and test plans as needed to support QC activities. * Train new peers in LIMS operations, including sample manager and resource modules. * Assist QC personnel with sample registration and label generation using the LIMS software Additional Responsibilities: * Performs other functions as required or assigned. * Hands on to follow compendial (USP/EP/BP/JP) procedures for wet chemical tests. * Must understand and apply cGMP requirements applicable to quality control laboratory. * Follow up on sample status and testing progress within the LIMS system. * Participate in continuous improvement initiatives to optimize LIMS functionality and workflows.

A primary focus of this role is creating and modifying LIMS test plans to support QC activities while adhering to regulatory and data integrity guidelines. The LIMS Coordinator is responsible for tracking and managing laboratory inventories within the LIMS system and to perform and verify daily verification of laboratory data for accuracy and completeness, ensuring compliance with GxP standards before submission for review. Essential Functions: Register samples and input relevant test results, instrument data, and laboratory information into the LIMS system as per QC procedures. Manage laboratory inventories, ensuring timely replenishment and accurate record-keeping within the LIMS system as well as generate and run standard reports from the LIMS system for Laboratory Resource tracking. Perform and verify daily verification data for accuracy and completeness before submitting it for review. Create, troubleshoot and modify LIMS Test, worksheets, and test plans as needed to support QC activities. Train new peers in LIMS operations, including sample manager and resource modules. Assist QC personnel with sample registration and label generation using the LIMS software Additional Responsibilities: Performs other functions as required or assigned. Hands on to follow compendial (USP/EP/BP/JP) procedures for wet chemical tests. Must understand and apply cGMP requirements applicable to quality control laboratory. Follow up on sample status and testing progress within the LIMS system. Participate in continuous improvement initiatives to optimize LIMS functionality and workflows. Education: Associate Degree - Required Bachelors Degree (BA/BS) Chemistry or related field - Preferred Experience: 1 year or more in Pharmaceutical/manutfacturing Skills: Proficient in laboratory informatics - Intermediate Strong understanding of regulatory compliance (FDA, GMP). - Intermediate Proficiency in inventory management systems and data analysis tools. - Intermediate Excellent organizational, communication, and problem-solving skills. - Intermediate The hourly rate for this position ranges from $22.00 to $26.00 per hour. In addition, Amneal offers a short-term incentive opportunity, such as a bonus or performance-based award, with this position within the first 12 months. Amneal ranges reflect the Company's good faith estimate of what 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, experience, 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 help you enjoy your career alongside life's many other commitments and opportunities.

Partner with us in making a positive change! Join a team where your work truly matters. We're proud to have been certified as a Great Place to Work for 8 years by our own employees. We invite you to partner with us in our mission to improve mental healthcare. Job Title: Quality Assurance Specialist Division/Program: City of Industry - Behavioral Health Urgent Care Center Starting Compensation: 24.09 - 25.34 USD Per Hour Working Location: City of Industry, CA Working Hours/Shift: Mon - Thurs: 7 AM - 5:30 PM Why Join Our Team? Competitive Compensation: Offering a salary that matches your skills and experience. Generous Time Off: Enjoy ample vacation and holiday pay. Comprehensive Benefits Package: Employer-paid medical, dental, and vision coverage. Additional voluntary benefits to support your lifestyle. Professional Growth Opportunities: On-the-job training with access to paid CEU opportunities. Career development programs designed to help you grow. Supervision for BBS hours for AMFT, ACSW, and APCC professionals (where applicable). Employee Recognition & Rewards: A culture that celebrates and rewards your hard work and dedication What you bring to SBHG (Qualifications): Bachelor's degree in Quality Improvement/Quality Assurance, human services, psychology, or related social science field, or LVN license Two (2) years of experience in the mental health field or a QA position required, preferably in in-patient setting. Two (2) years of experience in QA/TQM preferred. One (1) year experience in LACDMH clinical documentation preferred. Valid California Driver's License. How you will make a difference (Job Overview): The Quality Assurance Specialist is responsible for the Quality Assurance Program for the Behavioral Health Urgent Care Centers. The position is responsible for auditing documentation to reconcile with billing and oversees documentation of services by staff to assure conformity with Medi-Cal, Los Angeles County, other outside agencies, and internal standards and policies. The Quality Assurance Specialist manages all charts with deficiencies by processing them to the appropriate department for correction. The position is also responsible for insuring the discharged chart is closed in the correct order and completed. Position oversees the Continuous Quality Assurance program, medical records and records all CQI data. Full coordination and development of CQI presentations and information gathering to execute presentations as needed. Activities performed can be time sensitive with expectations of frequent reporting of progress along with thorough oversight for accuracy. Regular interaction with all staff members, physicians, and outside agencies is expected. This position has responsibility for gathering and analyzing agency data and assisting in the agency's quality control, quality assurance, and quality improvement efforts. In addition, the Quality Assurance Specialist's duties will include but are not limited to insuring that the chart order is maintained, data collection into the L.A. County data collection sites is maintained and other quality improvement tasks as assigned. Division/Program Overview: 24/7 outpatient program Rapid mental health assessment, crisis intervention, and medication support Walk-in's welcome Clients may stay up to 24 hours BHUCC equipped to serve 12 adults (ages 18 and up) and 6 adolescent (ages 13 to 17) Learn more about SBHG at: *********************************** For Additional Information: ********************** In accordance with California law, the grade for this position is 24.84 - 39.74. Placement within the grade is determined based on experience, internal equity, and other factors permitted by law.

**Why Us?** We want the best and brightest people to help us achieve our mission to develop and deliver life-enhancing products through focused execution. Our nearly 3,000 global team members understand the important role we play in delivering healthcare and are dedicated to supporting each other as we work to bring the best treatments forward. Our shared values of Integrity & Quality, Innovation, Drive, Collaboration and Empathy guide our team and enable us to deliver upon our vision of helping everyone we serve live their best life. ** Summary** Depending on the laboratory area, will perform analysis on Raw Materials, Intermediates, In-Process, Finished Product, or Stability samples using established analytical methods. **Job Description** **ESSENTIAL FUNCTIONS:** + Follow good documentation practices for the accurate and timely documentation of all activities. + Perform wet chemistry and instrumentation testing. + Follow site HSE Policies. + Assist with establishing and maintaining safe work standards in the lab. + Peer review all levels of work. + Conducts lab investigations. **DEPARTMENT SPECIFIC/NON-ESSENTIAL FUNCTIONS** **:** + LIMS entry of data + Use of analytical balances, HPLC, GC, KF Titrator, UV, pH Meter + Maintain instrument readiness **MINIMUM REQUIREMENTS** **:** _Education:_ High School Diploma required, associate degree in a science related field or equivalent combined education, experience, and competencies preferred. _Experience:_ Experience in a cGMP environment is preferred. Working knowledge of instrumentation preferred. _Preferred Skills/Qualifications:_ + Working knowledge of wet chemistry required + Working knowledge of instrumentation (GC/LC, UV, AA). + Experience in a cGMP environment is preferred. + Basic computer skills and familiarity with Microsoft Office Suite. + Substantial acquaintance with and understanding of application of basic principles, theories and concept. + Use and/or Basic knowledge of industry practices and standards. + Chromatography (GC/LC) and Spectroscopy experience a plus. **COMPETENCIES:** Informing, Customer Focus, Listening, Perseverance, Organizing, function/technical skills, Peer Relationships, Comfort around Higher Management **ORGANIZATIONAL RELATIONSHIP/SCOPE:** Contacts involve matters of moderate importance to the organization and include R&D, Marketing, Production employees including Engineers, Supervisors, and Operators, Logistics, EHS, and DEA. Infrequent customer contacts on routine matters. **WORKING CONDITIONS:** + 80% Laboratory exposure to plant products, solvents and reagents, some of which are hazardous or potent compounds. + 20% Office environment. + Required to work 8-12 hour shifts, the potential for night, weekend, and holiday work depending on the lab **DISCLAIMER:** _The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills require_ **EEO Statement:** We comply with all applicable federal, state, and local laws prohibiting discrimination and harassment, and provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, disability, veteran status, or genetic information, or any other classification protected by federal, state or local law. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

Why Us? We want the best and brightest people to help us achieve our mission to develop and deliver life-enhancing products through focused execution. Our nearly 3,000 global team members understand the important role we play in delivering healthcare and are dedicated to supporting each other as we work to bring the best treatments forward. Our shared values of Integrity & Quality, Innovation, Drive, Collaboration and Empathy guide our team and enable us to deliver upon our vision of helping everyone we serve live their best life. Summary Depending on the laboratory area, will perform analysis on Raw Materials, Intermediates, In-Process, Finished Product, or Stability samples using established analytical methods. Job Description ESSENTIAL FUNCTIONS: Follow good documentation practices for the accurate and timely documentation of all activities. Perform wet chemistry and instrumentation testing. Follow site HSE Policies. Assist with establishing and maintaining safe work standards in the lab. Peer review all levels of work. Conducts lab investigations. DEPARTMENT SPECIFIC/NON-ESSENTIAL FUNCTIONS: LIMS entry of data Use of analytical balances, HPLC, GC, KF Titrator, UV, pH Meter Maintain instrument readiness MINIMUM REQUIREMENTS: Education: High School Diploma required, associate degree in a science related field or equivalent combined education, experience, and competencies preferred. Experience: Experience in a cGMP environment is preferred. Working knowledge of instrumentation preferred. Preferred Skills/Qualifications: Working knowledge of wet chemistry required Working knowledge of instrumentation (GC/LC, UV, AA). Experience in a cGMP environment is preferred. Basic computer skills and familiarity with Microsoft Office Suite. Substantial acquaintance with and understanding of application of basic principles, theories and concept. Use and/or Basic knowledge of industry practices and standards. Chromatography (GC/LC) and Spectroscopy experience a plus. COMPETENCIES: Informing, Customer Focus, Listening, Perseverance, Organizing, function/technical skills, Peer Relationships, Comfort around Higher Management ORGANIZATIONAL RELATIONSHIP/SCOPE: Contacts involve matters of moderate importance to the organization and include R&D, Marketing, Production employees including Engineers, Supervisors, and Operators, Logistics, EHS, and DEA. Infrequent customer contacts on routine matters. WORKING CONDITIONS: 80% Laboratory exposure to plant products, solvents and reagents, some of which are hazardous or potent compounds. 20% Office environment. Required to work 8-12 hour shifts, the potential for night, weekend, and holiday work depending on the lab DISCLAIMER: The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills require EEO Statement: We comply with all applicable federal, state, and local laws prohibiting discrimination and harassment, and provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, disability, veteran status, or genetic information, or any other classification protected by federal, state or local law. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.