Quality Assurance Specialist jobs at CBRE Group

The Primary Injection Specialist is responsible for performing high-current primary injection testing on circuit breakers and related electrical equipment within a mission-critical data center environment. This role ensures the reliability, safety, and compliance of electrical distribution systems through precise testing and documentation. The pay listed is the base hourly rate for this position. A specific offer will vary based on applicant's experience, skills, abilities, geographic location, and alignment with market data. Benefit Information: ABM offers a comprehensive benefits package. For information about ABM's benefits, visit ABM Team Member Benefits | Front Line Team Members | (Programa de Beneficios de ABM) Key Responsibilities Perform primary injection testing on low-voltage and medium-voltage circuit breakers to verify trip settings and functionality. Inspect, calibrate, and maintain electrical protection devices in accordance with manufacturer specifications and industry standards. Document all test results, corrective actions, and recommendations in detailed reports. Collaborate with data center operations teams to schedule testing with minimal impact on uptime. Ensure compliance with NFPA 70E, OSHA, and company safety protocols, including Lockout/Tagout (LOTO). Operate and maintain high-current test equipment and associated tools. Troubleshoot breaker performance issues and assist in repairs or replacements as needed. Maintain truck inventory of tools and testing equipment. Qualifications High school diploma or equivalent; technical or electrical certification preferred. 3-5 years of experience in electrical testing, breaker maintenance, or related field. Proficiency in primary injection testing equipment and procedures. Strong understanding of electrical distribution systems and protective devices. Ability to read and interpret electrical schematics and technical manuals. Excellent attention to detail and documentation skills. Valid driver's license (company truck provided). Preferred Skills Not Required NETA Level II or III Certification or NICET Electrical Testing Certification. Experience working in data center environments or other mission-critical facilities. Familiarity with breaker maintenance programs and predictive testing strategies. Strong troubleshooting and problem-solving skills under time-sensitive conditions. Physical Requirements Ability to lift up to 50 lbs and work in confined spaces or elevated areas. Comfortable wearing PPE and working in energized environments under strict safety protocols. Why Join Us? Competitive pay and benefits. Company-provided truck and tools. Opportunities for growth in mission-critical environments. #200 About Us ABM (NYSE: ABM) is one of the world's largest providers of facility services and solutions. A driving force for a cleaner, healthier, and more sustainable world, ABM provides essential services and forward-looking performance solutions that improve the spaces and places that matter most. From curbside to rooftop, ABM's comprehensive services include janitorial, engineering, parking, electrical and lighting, energy and electric vehicle charging infrastructure, HVAC and mechanical, landscape and turf, and mission critical solutions. ABM serves a wide range of industries - from commercial office buildings to universities, airports, hospitals, data centers, manufacturing plants and distribution centers, entertainment venues and more. Founded in 1909, ABM serves over 20,000 clients, with annualized revenue approaching $8 billion and more than 100,000 team members in 350+ offices throughout the United States, United Kingdom, Republic of Ireland, and other international locations. For more information, visit ******************* ABM is proud to be an Equal Opportunity Employer qualified applicants without regard race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran or any other protected factor under federal, state, or local law. ABM is committed to working with and providing reasonable accommodation to individuals with disabilities. If you have a disability and need assistance in completing the employment application, please call ************. We will provide you with assistance and make a determination on your request for reasonable accommodation on a case-by-case basis. ABM participates in the U.S. Department of Homeland Security E-Verify program. E-Verify is an internet-based system used to electronically confirm employment eligibility. ABM is a military-friendly company proudly employing thousands of men and women who have served in the U.S. military. With ABM, you'll have access to a world-class training program and ample opportunities to use the skills you developed while serving our country. Whether you're looking for a frontline or professional position, you can find post-military career opportunities across ABM. ABM directs all applicants to apply at ******************* ABM does not accept unsolicited resumes.

*** We are seeking a Quality Specialist with hands-on experience in electrical and electro-mechanical assembly, PCBA inspection, and wire harnessing to support our growing production environment. This role focuses on non-conformance management, MRB support, and driving issues to resolution, rather than audits or general mechanical assembly. The ideal candidate can identify defects accurately, document them clearly, and anticipate the information needed for engineering teams to resolve issues efficiently. Preferred Qualifications: Experience in aerospace or high-reliability industries. Certification or training in IPC-A-610, IPC/WHMA-620, or ESD control. Experience writing and processing defect tags or non-conformance reports. Exposure to electro-mechanical troubleshooting or rework processes. Some mechanical assembly experience is a plus but not required. Key Responsibilities: Inspect and verify electrical and electro-mechanical assemblies, including PCBA fabrication, wire harnesses, and ESD-sensitive components. Manage non-conformance reports (NCRs) and support MRB processes, ensuring rejected parts are properly documented and resolved. Identify defects, determine potential root causes, and coordinate rework or repair paths. Collaborate with engineering and production teams to anticipate required information and drive non-conformance issues to closure. Apply IPC-A-610, IPC/WHMA-620, and ESD standards to ensure quality and compliance. Work effectively in fast-paced, high-reliability production environments with incomplete information. ***this is an electrical position***

Use Your Power for Purpose The Senior Customer Quality Operations Professional is the sole responsible colleague for providing quality support related to PGS McPherson Pfizer CentreOne contract manufacturing customers. Responsible for both new businessand commercial accounts. Colleague will be required to support multiple customers, can multi-task through each customer issue/requests, work with site SMEs for each activity as needed and represent Pfizer in a professional manner. This position functions as a member of the Quality AssuranceInternal & External Supply Group that supports quality assurance for the site, suppliers that support the site and Customers that the site contract manufactures for. This individual will act as Project Lead for Quality Systems to collaborate with customers and cross-functionally throughout the facility to ensure delivery of Quality Product for our Customers. This role will also have additional responsibilities to drive systems for the team and act as oversight for Customer Quality Operations Professionals on the team. What You Will Achieve Lead discussion with Customers on the Quality aspects of all manufacturing processes specific to assigned Pfizer CentreOne customers. These processes include but are not limited to supplier qualification, manufacturing, packaging, lab testing, release, shipping, market distribution, complaints, regulatory filings and market action. Quality Project lead for all contract reviews, creation of new quality technical agreements, assurance of site capabilities as it pertains to quality processes, understanding of development activities and identification of issues for escalation and initial quality audits. Oversee systems of Continuous Improvements for Customer Quality Operation Professionals and additional responsibilities to drive performance. Lead Quality Resource for new customer due diligence meetings and quality audits. Responsible for Quality assessment of all new customer proposals. Develop and Trend quality metrics for each individual Pfizer CentreOne customers. Project lead for areas for improvement through the metrics and driving continuous improvement opportunities to present to the customers and implementation. Draft, negotiate, and gain approval of the Quality Technical Agreement between Pfizer and the customer. Ensure the terms within the agreement are met by both parties. Perform a periodic review of the agreement and update as required. Provide support for and coordinate Pfizer CentreOne customer manufacturing investigations. This will include assessment of scope, input of customer specific information/data, quality impact, escalation and review/approval. Perform communication, tracking and closure of manufacturing investigations, change requests and CAPAs for Pfizer CentreOne Customer specific records. Responsible for quality escalation and issue resolution as it impacts assigned Pfizer CentreOne customers. Support and participate in customer audits and regulatory inspections. Lead Projects between Pfizer CentreOne customers and plant quality functions specific to assigned customers. Here Is What You Need (Minimum Requirements) Applicant must have a bachelor's degree with at least 2 years of experience; OR a master's degree with more than 0+ years of experience; OR an associate's degree with 6 years of experience; OR a high school diploma (or equivalent) and 8 years of relevant experience Solid understanding of current Good Manufacturing Practices and relevant GxP regulations and standards Strong oral and written communication, presentation and interpersonal skills Working knowledge of PC and Software (MS Office) Strong analytical skills required. Must be capable of organizing and analyzing data from multiple sources and extracting key information to achieve goals. Bonus Points If You Have (Preferred Requirements) Previous experience in internal assessment program, auditing, and/or walkthrough audits Production operations and/or Laboratory knowledge preferred PHYSICAL/MENTAL REQUIREMENTS Ability to stand for 1 hour a time, sit for 2 to 3 hours a time. Require working in an office stetting where sitting and computer usage would be typical. may include walking throughout site to support Regulatory Inspection activities. Requires tactful, persuasive, and assertive interpersonal skills and the ability to work both independently and with teams. Requires training for controlled environments within the facility to help facilitate walkthroughs audits. NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS Must have the ability to simultaneously multi-task across multiple capabilities and functions and handle multiple competing priorities and requirements, including performing site and functional responsibilities, responding to frequent e-mail and phone communications and attending multiple meetings and conference calls. Note that these activities may not be time bound to core hours or presence at the site. Must have the ability to work effectively under and manage to strict production, time and performance deadlines. Must be willing and able to work beyond the hours typically defined as a “regular” workday, which may or may not include weekends and holidays. Other Job Details: Work Location Assignment: Hybrid Last day to apply: December 17th The annual base salary for this position ranges from $80,300.00 to $133,900.00. In addition, this position is eligible for participation in Pfizer's Global Performance Plan with a bonus target of 10.0% of the base salary. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life's moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage. Learn more at Pfizer Candidate Site - U.S. Benefits | (uscandidates.mypfizerbenefits.com). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa, FL or any location outside of the United States. Relocation assistance may be available based on business needs and/or eligibility. Sunshine Act Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative. EEO & Employment Eligibility Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer. This position requires permanent work authorization in the United States. Pfizer endeavors to make ********************** accessible to all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process and/or interviewing, please email ...@pfizer.com. This is to be used solely for accommodation requests with respect to the accessibility of our website, online application process and/or interviewing. Requests for any other reason will not be returned. Quality Assurance and Control

Responsible for timely review and corrections (if needed) are made to entries that are submitted to US Customs/Government Agencies for entry of goods; to ensure that all customer and regulatory requirements are met. Provide impeccable customer service Support other workgroups such as but not limited to entry processing and cage functions. Obtain correct classification of goods for customs release from database, SOP's, tariff book, internet or customs. Solicit and maintain all customs compliance documentation with customers. Must be able to handle confidential and/or sensitive information. Work closely with other internal staff, departments and customers to deliver high level of service to customers. Review customs entries for accuracy and re-process with corrections if required. This includes customs requirements, other agencies requirements and customer requirements. Review and corrects ABI errors and census warnings. Ensure all government and organizational policies are followed. Create a referral to document the corrections to ensure education and compliance to reduce future errors. Performs other or additional duties as assigned. Paid Training Provided. HS Diploma or GED required. 3 years of business or customer service experience preferred. Required - MS Office, Outlook, Office equipment (phone, fax, photocopier, printer, scanner). Excellent communication skills, verbal and written. Organizational Skills. Inter-personal skills. Problem solving Skills. Handle high volume of work. Handle time sensitive work. Ability to work independently with minimum supervision. Detail oriented. Able to work on a team Preferred Qualifications: Monday - Friday 7:00am-3:30pm - Hybrid FTN/USA/BUF/14150/555 Riverwalk Parkway Pay Transparency: This compensation range is provided as a reasonable estimate of the current starting salary range for this role across all potential locations. If this opportunity includes multiple job levels, the range is a reasonable estimate of the current starting salary for the lowest level to the current starting salary of the highest level. Actual starting pay would be determined by experience relative to the job, market level, pay at the location for this job and other job-related factors 3 permitted by law. An employee may be eligible for additional pay, premiums, or bonus potential. The Company offers eligible employees health, vision and dental insurance, retirement, and tuition reimbursement. Pay: $15.50-$24.29 Additional Details: Internal candidates, please upload your current/updated resume. FedEx Logistics provides freight forwarding, as well as import and export services that allow companies to reach markets throughout the world. They help customers of all sizes solve the intricacies of shipping goods globally by providing comprehensive international ocean and air freight forwarding, surface transportation and distribution, customs brokerage, trade and customs advisory services, and advanced e-commerce and trade facilitation solutions. We're glad you stopped by and hope your job search experience with FedEx Logistics, Inc. will be rewarding. We look forward to hearing from you! FedEx Logistics is an Equal Opportunity Employer including, Vets/Disability. Know Your Rights Pay Transparency FedEx Logistics will consider for employment qualified applicants with criminal histories in a manner consistent with the requirements of the FAIR Chance Initiative for Hiring Ordinance (FCIHOO) for the City of Los Angeles (LAMC 189.00) FedEx Logistics will not rely on the wage history of a prospective employee from any current or former employer when determining the wages for such individual at any stage in the employment process, including in the negotiation or drafting of any employment contract in accordance with Philadelphia Ordinance No. 160840.

Requisition ID # 168845 Job Category: Compliance / Risk / Quality Assurance Job Level: Individual Contributor Business Unit: Electric Operations Work Type: Hybrid Job Location: Dublin; Alameda; Alta; American Canyon; Angels Camp; Antioch; Auberry; Auburn; Avenal; Avila Beach; Bakersfield; Balch Camp; Bay Point; Bear Valley; Belden; Bellota; Belmont; Benicia; Berkeley; Brentwood; Brisbane; Buellton; Burney; Buttonwillow; Calistoga; Campbell; Canyon Dam; Canyondam; Capitola; Caruthers; Chico; Clearlake; Clovis; Coalinga; Colusa; Concord; Concord; Corcoran; Cottonwood; Cupertino; Daly City; Danville; Davis; Dinuba; Downieville; Emeryville; Eureka; Fairfield; Folsom; Fort Bragg; Fortuna; Fremont; French Camp; Fresno; Fresno; Fulton; Garberville; Geyserville; Gilroy; Goodyear; Grass Valley; Guerneville; Half Moon Bay; Hayward; Hinkley; Hollister; Holt; Houston; Huron; Jackson; Kerman; King City; Lakeport; Lemoore; Lincoln; Linden; Livermore; Lodi; Loomis; Los Banos; Lower Lake; Madera; Magalia; Manteca; Manton; Mariposa; Martell; Marysville; Maxwell; Menlo Park; Merced; Meridian; Millbrae; Milpitas; Modesto; Monterey; Montgomery Creek; Morgan Hill; Morro Bay; Moss Landing; Mountain View; Napa; Needles; Newark; Newman; Novato; Oakdale; Oakhurst; Oakland; Oakley; Olema; Orinda; Orland; Oroville; Palo Alto; Palo Cedro; Paradise; Parkwood; Paso Robles; Petaluma; Pioneer; Pismo Beach; Pittsburg; Placerville; Pleasant Hill; Point Arena; Potter Valley; Quincy; Rancho Cordova; Red Bluff; Redding; Richmond; Ridgecrest; Rio Vista; Rocklin; Roseville; Round Mountain; Sacramento; Salida; Salinas; San Bruno; San Carlos; San Francisco; San Francisco; San Jose; San Luis Obispo; San Mateo; San Rafael; San Ramon; San Ramon; Sanger; Santa Cruz; Santa Maria; Santa Nella; Santa Rosa; Selma; Shaver Lake; Sonoma; Sonora; South San Francisco; Springville; Stockton; Storrie; Taft; Tracy; Turlock; Twain; Ukiah; Vacaville; Vallejo; Walnut Creek; Wasco; Watsonville; West Sacramento; Wheatland; Whitmore; Willits; Willow Creek; Willows; Windsor; Winters; Woodland; Yuba City Department Overview Electric Operations ensures the delivery of clean, safe, reliable and affordable energy to nearly 16 million people in Northern and Central California. Electric Operations is responsible for every aspect of PG&E's electric distribution and transmission operations, including planning, engineering, maintenance and construction, asset management, business planning, restoration and emergency response. Position Summary Provides quality assurance (QA) for Electric Operations. Performs QA assessments for adherence to compliance requirements, company standards, laws and identified business process requirements to ensure processes, systems, structures and/or components meet required specifications. Develops clear and concise written reports to describe non-conformances or process gaps which are used to communicate recommendations for the eliminations of waste or process improvements cross-functionally with various stakeholders. May be assigned to support a specific department or area of the business. Scope may be limited to one regulatory agency or may include multiple agencies, laws, and regulations applicable to a specific department or area of the business. Supports revisions to the compliance and/or risk programs and tools as needed based on changes to applicable laws, regulations, and standards. Partners with Subject Matter Experts (SME), Requirement/Risk Owners, and business SMEs to develop controls, and metrics to hold the assigned owners accountable for compliance and/or risk management performance. This position is hybrid, working from your remote office and your assigned work location based on business need. The assigned work location will be within the PG&E Service Territory. PG&E is providing the salary range that the company in good faith believes it might pay for this position at the time of the job posting. This compensation range is specific to the locality of the job. The actual salary paid to an individual will be based on multiple factors, including, but not limited to, specific skills, education, licenses or certifications, experience, market value, geographic location, and internal equity. Although we estimate the successful candidate hired into this role will be placed towards the middle or entry point of the range, the decision will be made on a case-by-case basis related to these factors. Bay Minimum: $114,000 Bay Maximum: $182,000 &/OR CA Minimum: $108,000 CA Maximum: $173,000 This job is also eligible to participate in PG&E's discretionary incentive compensation programs. Job Responsibilities * Works independently, utilizing advanced knowledge of utility regulatory general orders to complete deep reviews and analysis. * Partners with cross organizational leaders on identifying root causes, trends, process improvements and in implementing solutions. * Provides assistance and coaching to lower-level peers, including on the job training. * May handle questions regarding more complex verification situations. * Acts as a technical resource for construction employees and field supervisors. * Validates quality of completed work by construction crew and inspection using advanced knowledge of company standards and procedures. * Leads cross-organizational special projects or initiatives and the go-to lead and subject-matter expert. * Summarizes and presents complex findings to leaders. * Uses advanced communication skills to determine appropriate content for target audience. * Establishes new processes for emergent quality audit requests. * Leads team of quality specialists to conduct audits Qualifications Minimum: * High School or GED-General Educational Development-GED Diploma * Relevant utility industry experience, 8 years * CA Class C License, or equivalent * Ability to travel up to 75 percent of working time with occasional overnight stays Desired: * Bachelor's Degree in Engineering, Construction Management, Business Management or related field or equivalent experience * 1 year of quality auditing/quality inspection experience. * 5 years equivalent experience in electric infrastructure or quality * 8 years Electric Journeyman utility experience * ASQ-American Society for Quality CQA-Certified Quality Auditor certification * ASQ-American Society for Quality CQIA-Certified Quality Improvement Associate certification * Six Sigma or other Lean/Quality related training * Strong data analysis and reporting skills. * Excellent teamwork and collaboration skills. * Broad knowledge of root causes investigation methods and techniques. * Excellent communication skills. * Strong attention to detail and organizational skills. * Proficiency with applicable data systems including Field Maps, Survey 123, SAP, Power BI, and Excel * SME regarding Work Procedures and Standards & Policies. * Highly flexible, self-directed, and able to adapt well to a rapidly changing environment * Expert knowledge and understanding of relevant federal, state, and local construction codes and standards and PGE construction standards, bulletins and guidance documents

What Quality Assurance contributes to Cardinal Health Quality develops and implements quality policies, procedures, and processes to ensure products and services comply with regulatory standards and specifications. Quality Assurance develops and implements a compliant and cost effective quality system that assures products and services are reliable, safe and effective. This job family provides oversight of production/manufacturing activities, training to operational and quality control personnel, and educates business leaders on Quality policies and procedures and ensures that all products and services are properly reviewed for quality and documented. Job Summary The Principal Specialist, Quality Assurance is responsible for reviewing all customer threshold activity requests for controlled substances in compliance with set standards. This job reviews inbound requests, assesses them for risk and escalates according the standard operating procedures. The Principal Specialist, Quality Assurance assists the Manager, Regulatory Management in data entry activity and documentation drafting/filing. This job ensures the consistent application of set threshold methodologies across the organization. Responsibilities Responsible for ensuring quality standards and procedures are followed at the Cardinal Health NPHS Warehouse. Authority for approval and disposition of raw materials, components, closures, APIs, and products at the Cardinal Health NPHS Warehouse. This includes review of analytical results which may support material release. Supporting and documenting investigations where required. Organizes documentation to ensure procedure timelines are met Additional responsibility may include overarching systems which support the warehouse, for example, equipment and facility (i.e., temperature management and mapping), packaging and labelling. QA site lead for SAP material management activities. Document and report quality and compliance issues to QA management as necessary. Prioritizes and ensures work is delivered in an efficient way. May assist in the material qualification of new materials May serve as a delegate or representative Performs other job duties as assigned. Qualifications 4-8 years of experience, preferred Quality and/or Operations Warehouse experience preferred Bachelor's degree in related field, or equivalent work experience, preferred What is expected of you and others at this level Applies comprehensive knowledge and a thorough understanding of concepts, principles, and technical capabilities to perform varied tasks and projects Understands technical/release material issues and evaluates their potential impact on quality and compliance. Reports errors in a timely and appropriate manner. Takes initiative and is accountable for areas of responsibility meeting regulatory requirements including but not limited to maintaining required trainings as appropriate to position requirements. Takes actions to continually improve quality and safety in daily work. Actively participates in improving work processes to meet and exceed expectations. Identifies opportunities for improvement based on process observations, outcome measures, and feedback. Will contribute to the development of policies and procedures Works on complex projects of large scope Develops technical solutions to a wide range of difficult problems Solutions are innovative and consistent with organization objectives Completes work independently; receives general guidance on new projects Work reviewed for purpose of meeting objectives May act as a mentor to less experienced colleagues Anticipated salary range: $79,700 - $113,800 Bonus eligible: No Benefits: Cardinal Health offers a wide variety of benefits and programs to support health and well-being. Medical, dental and vision coverage Paid time off plan Health savings account (HSA) 401k savings plan Access to wages before pay day with my FlexPay Flexible spending accounts (FSAs) Short- and long-term disability coverage Work-Life resources Paid parental leave Healthy lifestyle programs Application window anticipated to close: 10/07/2025 *if interested in opportunity, please submit application as soon as possible. The salary range listed is an estimate. Pay at Cardinal Health is determined by multiple factors including, but not limited to, a candidate's geographical location, relevant education, experience and skills and an evaluation of internal pay equity Candidates who are back-to-work, people with disabilities, without a college degree, and Veterans are encouraged to apply. Cardinal Health supports an inclusive workplace that values diversity of thought, experience and background. We celebrate the power of our differences to create better solutions for our customers by ensuring employees can be their authentic selves each day. Cardinal Health is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, ancestry, age, physical or mental disability, sex, sexual orientation, gender identity/expression, pregnancy, veteran status, marital status, creed, status with regard to public assistance, genetic status or any other status protected by federal, state or local law. To read and review this privacy notice click here

What Quality Assurance contributes to Cardinal Health Quality develops and implements quality policies, procedures, and processes to ensure products and services comply with regulatory standards and specifications. Quality Assurance develops and implements a compliant and cost-effective quality system that assures products and services are reliable, safe and effective. This job family provides oversight of production/manufacturing activities, training to operational and quality control personnel, and educates business leaders on Quality policies and procedures and ensures that all products and services are properly reviewed for quality and documented. Job Summary Reports to Manager, Quality Assurance. QA Principal Specialist is responsible for ensuring quality standards and procedures are followed and will oversee quality monitoring and assurance to ensure that all products manufactured are of the highest quality possible. Inspection and quality assurance activities to meet specifications and quality standards for variety of in-process and finished products. Authorized to inspect products to ensure the required quality standards are met. Responsibilities Inspecting and sampling of product throughout the manufacturing process. Establish and maintain quality control procedures. Assist in determining types of tests to be performed as well as documentation and reporting requirements. Interact regularly with manufacturing and service functions to establish quality standards for raw material, work in process, and finished products. Champion Quality, GMP compliance and EHS/Radiation Safety practices. Develop and lead GMP/GDP training of all employees. Follows/ mentors GDP/GMP requirements. Actively partner with plant management and personnel in troubleshooting quality deficiencies and implement corrective measures to eliminate quality problems. Assists in the release of the final product in compliance with applicable regulations (FDA, EU, etc.) and marketing authorizations. Responsible for the review and dispositioning of incoming raw materials and components. Assures quality events are complete and accurate and resolved in a timely manner that meets the expectations of applicable quality agreements. Responsible for approval of minor Quality Events. Ability to network across business and functional units to achieve positive outcomes. Able to challenge, appropriately, the design, conduct, and reporting of GMP activities including metrics and annual reporting. In that context, has the knowledge of the production process of the product. Understands technical/release product issues and evaluate their potential impact on product quality and compliance. Provides ideas for continuous improvement of the GMP Quality Management System. Escalates complex issues to management in a timely manner. Prioritizes and ensures work is delivered in an efficient way. Performs other job duties as assigned. Qualifications Bachelor's degree in related field, or equivalent work experience, preferred. Advanced Degree may be preferred 4-8 years' experience in related field, preferred What is expected of you and others at this level Applies comprehensive knowledge and a thorough understanding of concepts, principles, and technical capabilities to perform varied tasks and projects May contribute to the development of policies and procedures Works on complex projects of large scope Develops technical solutions to a wide range of difficult problems. Solutions are innovative and consistent with organization objectives Completes work independently receives general guidance on new projects Work reviewed for purpose of meeting objectives May act as a mentor to less experienced colleagues Anticipated salary range: $79,700 - $113,800 Bonus eligible: No Benefits: Cardinal Health offers a wide variety of benefits and programs to support health and well-being. Medical, dental and vision coverage Paid time off plan Health savings account (HSA) 401k savings plan Access to wages before pay day with my FlexPay Flexible spending accounts (FSAs) Short- and long-term disability coverage Work-Life resources Paid parental leave Healthy lifestyle programs Application window anticipated to close: 2/1/2026 *if interested in opportunity, please submit application as soon as possible. The salary range listed is an estimate. Pay at Cardinal Health is determined by multiple factors including, but not limited to, a candidate's geographical location, relevant education, experience and skills and an evaluation of internal pay equity Candidates who are back-to-work, people with disabilities, without a college degree, and Veterans are encouraged to apply. Cardinal Health supports an inclusive workplace that values diversity of thought, experience and background. We celebrate the power of our differences to create better solutions for our customers by ensuring employees can be their authentic selves each day. Cardinal Health is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, ancestry, age, physical or mental disability, sex, sexual orientation, gender identity/expression, pregnancy, veteran status, marital status, creed, status with regard to public assistance, genetic status or any other status protected by federal, state or local law. To read and review this privacy notice click here

What Quality Assurance contributes to Cardinal Health Quality develops and implements quality policies, procedures, and processes to ensure products and services comply with regulatory standards and specifications. Quality Assurance develops and implements a compliant and cost-effective quality system that assures products and services are reliable, safe and effective. This job family provides oversight of production/manufacturing activities, training to operational and quality control personnel, and educates business leaders on Quality policies and procedures and ensures that all products and services are properly reviewed for quality and documented. Job Summary * Reports to Manager, Quality Assurance. * QA Principal Specialist is responsible for ensuring quality standards and procedures are followed and will oversee quality monitoring and assurance to ensure that all products manufactured are of the highest quality possible. Inspection and quality assurance activities to meet specifications and quality standards for variety of in-process and finished products. * Authorized to inspect products to ensure the required quality standards are met. Responsibilities * Inspecting and sampling of product throughout the manufacturing process. * Establish and maintain quality control procedures. * Assist in determining types of tests to be performed as well as documentation and reporting requirements. * Interact regularly with manufacturing and service functions to establish quality standards for raw material, work in process, and finished products. * Champion Quality, GMP compliance and EHS/Radiation Safety practices. * Develop and lead GMP/GDP training of all employees. Follows/ mentors GDP/GMP requirements. * Actively partner with plant management and personnel in troubleshooting quality deficiencies and implement corrective measures to eliminate quality problems. * Assists in the release of the final product in compliance with applicable regulations (FDA, EU, etc.) and marketing authorizations. * Responsible for the review and dispositioning of incoming raw materials and components. * Assures quality events are complete and accurate and resolved in a timely manner that meets the expectations of applicable quality agreements. Responsible for approval of minor Quality Events. * Ability to network across business and functional units to achieve positive outcomes. * Able to challenge, appropriately, the design, conduct, and reporting of GMP activities including metrics and annual reporting. In that context, has the knowledge of the production process of the product. * Understands technical/release product issues and evaluate their potential impact on product quality and compliance. * Provides ideas for continuous improvement of the GMP Quality Management System. * Escalates complex issues to management in a timely manner. * Prioritizes and ensures work is delivered in an efficient way. * Performs other job duties as assigned. Qualifications * Bachelor's degree in related field, or equivalent work experience, preferred. Advanced Degree may be preferred * 4-8 years' experience in related field, preferred What is expected of you and others at this level * Applies comprehensive knowledge and a thorough understanding of concepts, principles, and technical capabilities to perform varied tasks and projects * May contribute to the development of policies and procedures * Works on complex projects of large scope * Develops technical solutions to a wide range of difficult problems. Solutions are innovative and consistent with organization objectives * Completes work independently receives general guidance on new projects * Work reviewed for purpose of meeting objectives * May act as a mentor to less experienced colleagues Anticipated salary range: $79,700 - $113,800 Bonus eligible: No Benefits: Cardinal Health offers a wide variety of benefits and programs to support health and well-being. * Medical, dental and vision coverage * Paid time off plan * Health savings account (HSA) * 401k savings plan * Access to wages before pay day with my FlexPay * Flexible spending accounts (FSAs) * Short- and long-term disability coverage * Work-Life resources * Paid parental leave * Healthy lifestyle programs Application window anticipated to close: 2/1/2026 *if interested in opportunity, please submit application as soon as possible. The salary range listed is an estimate. Pay at Cardinal Health is determined by multiple factors including, but not limited to, a candidate's geographical location, relevant education, experience and skills and an evaluation of internal pay equity Candidates who are back-to-work, people with disabilities, without a college degree, and Veterans are encouraged to apply. Cardinal Health supports an inclusive workplace that values diversity of thought, experience and background. We celebrate the power of our differences to create better solutions for our customers by ensuring employees can be their authentic selves each day. Cardinal Health is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, ancestry, age, physical or mental disability, sex, sexual orientation, gender identity/expression, pregnancy, veteran status, marital status, creed, status with regard to public assistance, genetic status or any other status protected by federal, state or local law.

Since 1869, we've connected people through food they love. We're proud to be stewards of amazing brands that people trust. Our portfolio includes the iconic Campbell's brand, as well as Cape Cod, Chunky, Goldfish, Kettle Brand, Lance, Late July, Pacific Foods, Pepperidge Farm, Prego, Pace, Rao's Homemade, Snack Factory, Snyder's of Hanover. Swanson, and V8. Here, you will make a difference every day. You will be supported to build a rewarding career with opportunities to grow, innovate and inspire. Make history with us. Why Campbell's… Benefits begin on day one and include medical, dental, short and long-term disability, AD&D, and life insurance (for individual, families, and domestic partners). Employees are eligible for our matching 401(k) plan and can enroll on the first day of employment with immediate vesting. Campbell's offers unlimited sick time along with paid time off and holiday pay. If in WHQ - free access to the fitness center. Access to on-site day care (operated by Bright Horizons) and company store. Giving back to the communities where our employees work and live is very important to Campbell's. Our “Campbell's Cares” program matches employee donations and/or volunteer activity up to $1,500 annually. Campbell's has a variety of Employee Resource Groups (ERGs) to support employees. How you will make history here... The QA Commercialization Specialist's primary role is assisting in the development and maintenance of formula and procedure systems. This includes responsibility for compliance to all company and regulatory policies/procedures pertaining to product safety/quality. The QA Commercialization Specialist will work with a cross functional commercialization team comprised of both corporate and plant functions to launch the manufacturing of new products at the plant. The candidate will have the hands-on opportunity to explore all quality areas of a food manufacturing plant including product realization, system and regulatory compliance, laboratory work, and grow into a technical resource for manufacturing, commercialization, and engineering. What you will do... 1. 40% - Assists with the implementation of all product formulas, procedures, and thermal process requirements including product startups, special batches, packaging trial and reformulation reviews, label compliance, and RMS administrator. 2. 30% - Supports the cross functional commercialization team in launching new products. 3. 15% - Actively participates in continuous improvement activities within systems and the plant. Uses various computer support systems for data manipulation, basic analysis and reports of product quality information. 4. 10% - Investigates and analyzes incidents and non-conformances, takes corrective action and/or makes recommendations as appropriate for routine incidents. Functions as QA representative on non-routine activities associated with project/team assignments which may include: specification development, quality design support, new product start-ups, training, instrument evaluation or method development, etc. Supports efforts to educate and train the workforce on food quality and safety programs. 5. 5% - Conduct pre-shipment reviews of food safety/quality records to assure regulatory compliance, including electronic record review and allow for timely release of product to meet customer service requirements. Conducts reviews and disposition of product requiring micro testing, container integrity evaluations, or Process Safety review/release. Who you will work with... Key working relationships that must be developed or maintained: Team working relationship with WHQ R&D, Quality Systems Technologist, operations and maintenance business unit leaders/team leaders. Establish and sustain effective relationships with all employees in order to foster an environment where innovation and cooperation are used to solve problems. What you bring to the table (Must Haves)... Bachelor's Degree 6 months years related experience in the food industry, microbiology or related field; internships/co-ops will be considered. It would be great if you have (Nice to Haves)... Preferred discipline in Food Science, Microbiology or related field High level of computer skills including electronic formula database, PLC, RMS, and working with Engineers to set up the plant floor automation for product processes. Strong leadership, interpersonal, communication and analytical skills. Ability to lead by involving others in decision processes. Ability to implement change, motivate others and encourage team development. Ability to manage multiple tasks and adjust priorities. Strong organization skills. Strong written communication skills. Detail Oriented Critical Thinking Skills Compensation and Benefits: The target base salary range for this full-time, salaried position is between $55,900-$80,400 Individual base pay depends on work location and additional factors such as experience, job-related skills, and relevant education or training. Total pay may include other forms of compensation. In addition, we offer competitive health, dental, 401k and wellness benefits beginning on the first day of employment. Please ask your Talent Acquisition Partner for more information about our total rewards package. The Company is committed to providing equal opportunity for employees and qualified applicants in all aspects of the employment relationship, including consideration for employment, without regard to race, color, sex, sexual orientation, gender identity, national origin, citizenship, marital status, protected veteran status, disability, age, religion, or any other classification protected by law.

Since 1869 we've connected people through food they love. We're proud to be stewards of amazing brands that people trust. Our portfolio includes the iconic Campbell's brand, as well as Michael Angelo's, Pace, Pacific Foods, Prego, Rao's Homemade, Swanson, and V8. In our Snacks division, we have brands like Cape Cod, Goldfish, Kettle Brand, Lance, Late July, Pepperidge Farm, Snack Factory, and Snyder's of Hanover. Here, you will make a difference every day. You will be supported to build a rewarding career with opportunities to grow, innovate and inspire. Make history with us. Why Campbell's… Benefits begin on day one and include medical, dental, short and long-term disability, AD&D, and life insurance (for individual, families, and domestic partners). Employees are eligible for our matching 401(k) plan and can enroll on the first day of employment with immediate vesting. Campbell's offers unlimited sick time along with paid time off and holiday pay. If in WHQ - free access to the fitness center. Access to on-site day care (operated by Bright Horizons) and company store. Giving back to the communities where our employees work and live is very important to Campbell's. Our "Campbell's Cares" program matches employee donations and/or volunteer activity up to $1,500 annually. Campbell's has a variety of Employee Resource Groups (ERGs) to support employees. How you will make history here... The QA Commercialization Specialist's primary role is assisting in the development and maintenance of formula and procedure systems. This includes responsibility for compliance to all company and regulatory policies/procedures pertaining to product safety/quality. The QA Commercialization Specialist will work with a cross functional commercialization team comprised of both corporate and plant functions to launch the manufacturing of new products at the plant. The candidate will have the hands-on opportunity to explore all quality areas of a food manufacturing plant including product realization, system and regulatory compliance, laboratory work, and grow into a technical resource for manufacturing, commercialization, and engineering. What you will do... 1. 40% - Assists with the implementation of all product formulas, procedures, and thermal process requirements including product startups, special batches, packaging trial and reformulation reviews, label compliance, and RMS administrator. 2. 30% - Supports the cross functional commercialization team in launching new products. 3. 15% - Actively participates in continuous improvement activities within systems and the plant. Uses various computer support systems for data manipulation, basic analysis and reports of product quality information. 4. 10% - Investigates and analyzes incidents and non-conformances, takes corrective action and/or makes recommendations as appropriate for routine incidents. Functions as QA representative on non-routine activities associated with project/team assignments which may include: specification development, quality design support, new product start-ups, training, instrument evaluation or method development, etc. Supports efforts to educate and train the workforce on food quality and safety programs. 5. 5% - Conduct pre-shipment reviews of food safety/quality records to assure regulatory compliance, including electronic record review and allow for timely release of product to meet customer service requirements. Conducts reviews and disposition of product requiring micro testing, container integrity evaluations, or Process Safety review/release. Who you will work with... Key working relationships that must be developed or maintained: Team working relationship with WHQ R&D, Quality Systems Technologist, operations and maintenance business unit leaders/team leaders. Establish and sustain effective relationships with all employees in order to foster an environment where innovation and cooperation are used to solve problems. What you bring to the table (Must Haves)... * Bachelor's Degree * 6 months years related experience in the food industry, microbiology or related field; internships/co-ops will be considered. It would be great if you have (Nice to Haves)... * Preferred discipline in Food Science, Microbiology or related field * High level of computer skills including electronic formula database, PLC, RMS, and working with Engineers to set up the plant floor automation for product processes. * Strong leadership, interpersonal, communication and analytical skills. * Ability to lead by involving others in decision processes. * Ability to implement change, motivate others and encourage team development. * Ability to manage multiple tasks and adjust priorities. * Strong organization skills. * Strong written communication skills. * Detail Oriented * Critical Thinking Skills Compensation and Benefits: The target base salary range for this full-time, salaried position is between $55,900-$80,400 Individual base pay depends on work location and additional factors such as experience, job-related skills, and relevant education or training. Total pay may include other forms of compensation. In addition, we offer competitive health, dental, 401k and wellness benefits beginning on the first day of employment. Please ask your Talent Acquisition Partner for more information about our total rewards package. The Company is committed to providing equal opportunity for employees and qualified applicants in all aspects of the employment relationship, including consideration for employment, without regard to race, color, sex, sexual orientation, gender identity, national origin, citizenship, marital status, protected veteran status, disability, age, religion, or any other classification protected by law.

World's largest independent upstream oil and gas business SPIRIT values - Safety People Integrity Responsibility Innovation Teamwork Operations in 13 countries ConocoPhillips is hiring for a Willow Construction Mechanical QA Coordinator contract role, based in Alpine, AK. JOB DESCRIPTION Current AWS CWI required. General Summary: This position is responsible for monitoring site quality assurance/quality control (QA/QC) activities within his/her prevue and providing direction to contractor QA/QC personnel. He/she supports the development and implementation of effective QA/QC through processes, procedures, training, control measures, corrective and preventive action, assessment, documentation and audit, measurement and analysis, and continuous improvement. Critical and leadership skills include: Understanding and implementation of quality assurance and quality control processes and procedures during the construction phase of a project. Must be able to build and maintain a good working relationship within the contractor quality organization. Essential Duties & Responsibilities: Responsible for the administration of the project/site quality requirements to ensure contractors compliance of project specifications and practices as they relate to quality during the construction phase in the field. Coordinating with construction to ensure timely execution of quality activities. Assists in the development and review Quality Assurance procedures & processes. Identification and control of Deficient Conditions (Deficiency Reports, Non-Conformance Reports, and Corrective Action Reports) and process. Current AWS CWI required. Follow-up on corrective actions and NCRs including verification of disposition and effectiveness of corrective and preventive actions. The Construction Quality Assurance Coordinator is accountable for and as required responsible performing the following: Review of Contractor Quality Plans ITPs and procedures and ensuring they are as per specifications. Provide verification of Contractors' implementation of their construction processes and procedures through execution of the construction surveillance program. Participate in contractors' kick offs to outline Quality requirements. Participates in ITP witness and hold point activities as indicated in the approved ITP. Review hydro test packs and participates in pre-hydro test walk-downs of process piping and/or pipelines. Witness hydro tests and participate in piping reinstatement walk downs. Reviewing PMI and NDE reports, e.g., RT, UT, MT, etc. Assure pipeline installation meets the requirements of SPC-PT-WL-80011, Construction of Above Grade Pipeline / Well line Specification. Reviewing contractor IQRs. Participates in document reviews and turnover reviews. Sign-off of turnover documentation for COP where appropriate. ConocoPhillips contract opportunities are for project-based or other short-term engagements that require specialized skills. Successful candidates for contract opportunities will not be considered employees of ConocoPhillips or any of its subsidiaries nor will candidates be eligible for employment benefits. Candidates looking for regular full-time employment opportunities should begin their search here: ***********************************

World's largest independent upstream oil and gas business SPIRIT values - Safety People Integrity Responsibility Innovation Teamwork Operations in 13 countries ConocoPhillips is hiring for a Willow Construction E&I Quality Assurance Coordinator contract role, based in Alpine, AK. JOB DESCRIPTION Current Alaska State Fitness Card required. General Summary: This position is responsible for monitoring site quality assurance/quality control (QA/QC) activities within his/her prevue and providing direction to contractor QA/QC personnel. He/she supports the development and implementation of effective QA/QC through processes, procedures, training, control measures, corrective and preventive action, assessment, documentation and audit, measurement and analysis, and continuous improvement. Critical and leadership skills include: Understanding and implementation of quality assurance and quality control processes and procedures during the construction phase of a project. Must be able to build and maintain a good working relationship within the contractor quality organization. Essential Duties & Responsibilities: Responsible for the administration of the project/site quality requirements to ensure contractors compliance of project specifications and practices as they relate to quality during the construction phase in the field. Coordinating with construction to ensure timely execution of quality activities. Assists in the development and review Quality Assurance procedures & processes. Identification and control of Deficient Conditions (Deficiency Reports, Non-Conformance Reports, and Corrective Action Reports) and process. Current Alaska State Fitness Card required. Follow-up on corrective actions and NCRs including verification of disposition and effectiveness of corrective and preventive actions. The Construction Quality Assurance Coordinator is accountable for and as required responsible performing the following: Review of Contractor Quality Plans ITPs and procedures and ensuring they are as per specifications. Provide verification of Contractors' implementation of their fabrication processes and procedures through execution of the quality surveillance program. Participate in contractors' kick offs to outline Quality requirements. Participates in ITP witness and hold point activities as indicated in the approved ITP. Ensure all inspection and testing is in accordance with SPC-EE-WL-80300, Electrical Construction Specification. Verify that electrical material and equipment are inspected by an electrical administrator upon completion of installation per Alaska Statute Title 8, Section 08.40.195. Review and sign-off contractor electrical and instrument IQRs. Participates in system walkdowns. Participates in document reviews and turnover reviews. Sign-off of turnover documentation for COP where appropriate. ConocoPhillips contract opportunities are for project-based or other short-term engagements that require specialized skills. Successful candidates for contract opportunities will not be considered employees of ConocoPhillips or any of its subsidiaries nor will candidates be eligible for employment benefits. Candidates looking for regular full-time employment opportunities should begin their search here: ***********************************

Career CategoryQualityJob Description Join Amgen's Mission of Serving Patients At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do. Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Specialist Quality Assurance Location Easton, Pennsylvania - ON-SITE What you will do Let's do this! Let's change the world! This onsite position provides critical support for the Raw Material Center (RMC) warehouse, based in Easton, Pennsylvania. The RMC represents an advanced logistics solution designed to optimize the raw material network, serve additional manufacturing sites, and facilitate inventory pooling and bulk purchasing. RMC services encompass direct supplier receipt, incoming quality inspection and sampling, environmental monitoring, storage, and transportation. Responsibilities: Ensure that all operations align with relevant regulations and Amgen requirements, including Safety, Good Manufacturing Practices (GMP), Good Distribution Practices (GDP), and Good Documentation Practices Conduct sampling and inspection of incoming raw materials, assess documentation, and determine disposition Review documentation associated with receipt, storage, and distribution Approve GMP processes, procedures, documents, and records, addressing deviations, CAPAs, change controls, risk assessments, and validation records as required Perform routine Quality Assurance assessments and provide direct operational oversight Offer leadership, guidance, mentorship, and training to staff and partner organizations Manage oversight of logistic and transportation service providers Provide expert advice on quality matters to operational teams and cross-functional groups Ensure staff complete necessary training related to Amgen business operations Achieve established metric targets and develop standardized approaches for tracking progress Collaborate with Logistic Service Providers (LSPs) to maintain service levels and identify areas for performance enhancement Participate in quarterly business and quality reviews and address any service failures with LSPs Present updates on LSP Quality Management System health and initiatives at management reviews Represent the Quality Unit during audits and inspections, directly interacting with regulatory agencies Support internal and external audits and inspections as a member of the audit/inspection team Implement business continuity plans for services and processes Form strategic partnerships with internal customers and external vendors to ensure operational success Integrate risk management strategies into overall supply chain management Lead initiatives, programs, and projects targeting operational improvements Develop solutions that are comprehensive, practical, and align with functional goals Perform additional duties as assigned by management What we expect of you We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is an individual with these qualifications. Basic Qualifications: Doctorate degree OR Master's degree and 2 years of quality assurance experience OR Bachelor's degree and 4 years of quality assurance experience OR Associate's degree and 8 years of quality assurance experience OR High school diploma / GED and 10 years of quality assurance experience Preferred Qualifications: Proven ability to communicate effectively with cross-functional teams and diverse cultures, both verbally and in writing Academic background in Life Sciences, Physical Sciences, Applied Engineering, or Manufacturing Technologies Prior experience overseeing QA in distribution, warehousing, manufacturing, validation, and engineering functions Expertise in managing deviations, change controls, and CAPAs Proficiency in Veeva, SM LIMS, and ERP systems Knowledge of industry standards (GMP, GDP, Import/Export) Commitment to exemplifying Amgen's core values Demonstrated self-leadership and motivation Strong critical thinking skills Ability to evaluate compliance issues and engage with regulatory inspectors Experience managing multiple priorities within a dynamic environment Direct experience with drug substances and/or drug products Advanced problem-solving abilities and capacity for scientific, risk-based decision-making Track record of representing an organization during regulatory interactions High proficiency in Microsoft Excel, Word, and PowerPoint What you can expect from us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way. The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications. In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include: A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan Stock-based long-term incentives Award-winning time-off plans Flexible work models where possible. Refer to the Work Location Type in the job posting to see if this applies. Apply now and make a lasting impact with the Amgen team. careers.amgen.com In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information. Application deadline Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position. Sponsorship Sponsorship for this role is not guaranteed. As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. . Salary Range 109,307.00 USD - 129,509.00 USD

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: 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. Responsibilities: The Quality Assurance Process team member is responsible for demonstrating leadership, teamwork, and quality knowledge on a day to day basis. They are responsible to lead, mentor, and coach operations and support personnel on quality matters. They will provide support on deviations, change controls, procedure updates, commissioning, and qualification activities. This role will have a regular presence in the operational areas to monitor and confirm execution according to quality standards. This role will participate on the local process team for one of following manufacturing areas: * Device Assembly * Packaging * Project Focus for DAP Responsibilities include: * Active presence in operational areas * Provide quality oversight for the verification and qualification of the manufacturing equipment, buildings, including review of test cases, test execution, discrepancy resolution, etc. * Provides guidance for leveling, resolving, reviewing and approving deviations and change controls * Demonstrate a comprehensive understanding of the process and its associated equipment, facilities, computer systems and operations * Lead and establish annual quality floor time plan * Support resolution of batch documentation such as alarm response, exceptions, etc * Support asset qualification monitoring reviews and reports * May be required to respond to operational issues outside of core business hours / days. * Attend and provide update on quality at daily process team meeting * Support the site organization in building technical capability, in Quality, the project team, and area process teams, including mentoring and training of new Quality staff * Resolve or escalate any compliance issues to Quality Management * Identify and implement continuous improvements * Measure, maintain, and achieve quality metrics * Serve as positive role models for their Process Team peers and for the organization in general Basic Requirements: * Bachelors or equivalent degree in a scientific field * 4+ years' experience in Quality pharmaceutical manufacturing required * Previous experience with C&Q / Verification and Validation oversight including automation and computer systems validation * Use process knowledge and control strategy to make quality decisions * Demonstrated knowledge and use of US, EU, Japan and other regulations in the area of pharmaceutical manufacturing * Demonstrated ability to communicate with cross-functional teams including good oral and written communication skills * Ability to work independently as a Quality SME with minimal supervision * Proficiency with computer systems including SAP, Trackwise, MES etc. * Responsible for maintaining a safe work environment, * Ability to work 8 hour shifts onsite (not eligible for remote work) * Ability to work overtime as required * 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 P1-P4. Additional Skills/Preferences: * ASQ Certified * CSQA experience * Previous experience with device assembly or packaging, * Previous experience with Manufacturing Execution Systems. * Previous use of KNEAT - or other electronic validation software * Previous technical writing experience 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

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

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. The Associate - CPQA-ARC Quality Assurance (QA) Complaint Investigator (hereafter referred to as Associate - QA) is responsible for evaluating product complaint record information to determine the: validity of the complaint; complaint level; complaint category(ies); investigation site and; where appropriate, complaint conclusions. The Associate - QA is responsible for performing batch number and/or product retrieval activities per applicable local procedures. The Associate - QA may also be responsible for performing and/or verifying visual and/or functional evaluations of returned complaint product and determining the appropriate triage of the returned product. The Associate - QA is responsible for determining any follow-up information required from the reporter or related contacts that may assist with the triage of the complaint record. Responsibilities: * Assess product complaint information, designate an appropriate complaint level, and assign suitable complaint and/or analysis category(ies). * Determine the need for additional investigation and forward product complaint records and/or complaint product to the proper manufacturing or packaging quality unit for further investigation, as required. * Where additional information may aid in determining the root cause of the product complaint, obtain supplementary information from the reporter and/or related parties. * Determine the need for the product complaint return and perform complaint product retrieval actions, per local procedures. * Perform visual and/or functional analysis of returned complaint product, per local procedures. * Assess product complaint information and the results of the returned complaint product, including impact on: complaint level; complaint category(ies); investigating site; and additional investigation requirements. * Respond to the customer with educational information, as applicable, during customer follow up activities (e.g., request for batch number and/or product complaint sample). * Forward process complaints and related activities in adherence to established timeframes * Apply cGMP principles in all phases of the product complaint investigation (e.g., data documentation). * Perform CPQA laboratory related tasks (e.g. returned product check-in, product shipping, waste drum disposal), as applicable. * Build and maintain working relationships with The Lilly Answers Center and other affiliates associated with the Americas Regional Center, as well as manufacturing and packaging sites, global pharmaceutical investigations team, global patient safety, and other regional complaint centers. * Serve as a subject matter expert (SME) for applicable CPQA-ARC procedures and work instructions. * Participate in departmental process improvement activities. * Conduct training and peer monitoring, as applicable. * Maintain appropriate training qualification to perform complaint investigation activities. Basic Requirements: * A bachelor's degree in health science related field (e.g., pharmacy, nursing, chemistry, biology, or engineering) * Minimum 2 years of work experience post degree Additional Preferences: * A health care professional background (e.g., degree in pharmacy or nursing). * Solid collaboration, teamwork and interpersonal skills. * Strong verbal and written communication skills in English. * Attention to detail. * Self-management / motivated. * Ability to multi-task. * Above average computer literacy and computer skills. Specific training for complaint handling software will be provided. * Strong curiosity skills with the ability to question/identify issues & work to resolution. * Strong critical thinking/problem solving skills with an ability to apply rationale. * Ability to mentor/train others - share learning. * Ability to safely work in a laboratory environment (e.g. wear appropriate personal protection, potential for exposure to allergens, able to lift 20 pounds). * Demonstrated knowledge of related quality systems * Experience within the field of devices or parenteral products. * Regulated industry experience (e.g., exposure to cGMPs), preferably in quality organizations Additional Information: * The position does not require shift work or frequent traveling. * Responsibility for after-hours and company shutdown coverage may be required. * The Associate - QA will work in an office and/or laboratory environment. * The Associate - QA may work in a laboratory environment with potential exposure to known allergens, oncolytics, and the contents of returned complaint product. * This position is based in Indianapolis, IN, requiring time onsite. 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 - $165,000 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

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. Join the energetic and growing Active Pharmaceutical Ingredient - External Manufacturing Organization (API-EM) that delivers a diverse portfolio of medicines essential to our patients around the world. Job Summary: This role provides essential Quality Assurance oversight for API External Manufacturing operations, ensuring compliance with cGMP and regulatory requirements for all products manufactured by third-party partners. Job Responsibilities: Lead and manage quality aspects of external API manufacturing sites, including but not limited to batch record review, disposition, deviation management, and change control. Conduct and/or participate in quality audits of external manufacturing sites to assess compliance with cGMP, regulatory expectations, and Eli Lilly's quality standards. Review and approve quality-related documents, such as manufacturing master batch records, validation protocols and reports, stability data, and analytical methods. Collaborate cross-functionally with internal teams (e.g., Supply Chain, Regulatory Affairs, Technical Services) and external manufacturing partners to resolve quality issues and drive continuous improvement. Provide expert QA guidance and support during new product introductions and technology transfers to external manufacturers. Develop, implement, and maintain quality agreements with external manufacturing organizations. Investigate and troubleshoot complex quality incidents, deviations, and out-of-specification results, determining root causes and implementing effective corrective and preventive actions (CAPAs). Represent Eli Lilly's quality interests during regulatory inspections at external manufacturing sites. Mentor and provide technical guidance to junior QA associates. Job Qualifications: Bachelor's degree in a scientific discipline (e.g., Chemistry, Biochemistry, Pharmacy, Chemical Engineering) or related field. Minimum of 5-8 years (Senior Associate) or 8+ years (Principal Associate) of experience in Quality Assurance within the pharmaceutical or biopharmaceutical industry, with a strong focus on API manufacturing and external supply. In-depth knowledge of cGMP regulations (FDA, EMA, HPRA, etc.) and global pharmacopeial requirements. Proven experience in auditing external manufacturing sites. Strong understanding of API manufacturing processes, analytical techniques, and quality control principles. Demonstrated ability to make sound quality decisions and effectively communicate complex technical and quality information to diverse audiences. Excellent problem-solving, analytical, and critical thinking skills. Ability to work independently and as part of a team in a fast-paced, dynamic environment. Proficiency in quality management systems (e.g., TrackWise, Veeva). Willingness to travel domestically and internationally to external manufacturing sites as required. 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

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: 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. Responsibilities: The Quality Assurance Process team member is responsible for demonstrating leadership, teamwork, and quality knowledge on a day to day basis. They are responsible to lead, mentor, and coach operations and support personnel on quality matters. They will provide support on deviations, change controls, procedure updates, commissioning, and qualification activities. This role will have a regular presence in the operational areas to monitor and confirm execution according to quality standards. This role will participate on the local process team for one of following manufacturing areas: Device Assembly Packaging Project Focus for DAP Responsibilities include: Active presence in operational areas Provide quality oversight for the verification and qualification of the manufacturing equipment, buildings, including review of test cases, test execution, discrepancy resolution, etc. Provides guidance for leveling, resolving, reviewing and approving deviations and change controls Demonstrate a comprehensive understanding of the process and its associated equipment, facilities, computer systems and operations Lead and establish annual quality floor time plan Support resolution of batch documentation such as alarm response, exceptions, etc Support asset qualification monitoring reviews and reports May be required to respond to operational issues outside of core business hours / days. Attend and provide update on quality at daily process team meeting Support the site organization in building technical capability, in Quality, the project team, and area process teams, including mentoring and training of new Quality staff Resolve or escalate any compliance issues to Quality Management Identify and implement continuous improvements Measure, maintain, and achieve quality metrics Serve as positive role models for their Process Team peers and for the organization in general Basic Requirements: Bachelors or equivalent degree in a scientific field 4+ years' experience in Quality pharmaceutical manufacturing required Previous experience with C&Q / Verification and Validation oversight including automation and computer systems validation Use process knowledge and control strategy to make quality decisions Demonstrated knowledge and use of US, EU, Japan and other regulations in the area of pharmaceutical manufacturing Demonstrated ability to communicate with cross-functional teams including good oral and written communication skills Ability to work independently as a Quality SME with minimal supervision Proficiency with computer systems including SAP, Trackwise, MES etc. Responsible for maintaining a safe work environment, Ability to work 8 hour shifts onsite (not eligible for remote work) Ability to work overtime as required 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 P1-P4. Additional Skills/Preferences: ASQ Certified CSQA experience Previous experience with device assembly or packaging, Previous experience with Manufacturing Execution Systems. Previous use of KNEAT - or other electronic validation software Previous technical writing experience 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

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