Quality Assurance Specialist jobs at Novo Nordisk - 461 jobs

A leading pharmaceutical company in San Diego seeks a Director, Quality Assurance (GCP) to oversee GCP QA systems, ensuring compliance with regulatory requirements. The role demands extensive experience in GCP as well as a strong leadership and auditing background. The ideal candidate will have a track record of developing quality strategies and collaborating across multiple teams. Competitive compensation includes a salary range of $176,000 - $220,000, alongside comprehensive health benefits and additional perks. #J-18808-Ljbffr

Breaking Data is a boutique healthcare marketing agency serving leading pharmaceutical, biotech, and medical device companies. We specialize in scientific storytelling, creative strategy, and high-impact communications that bring complex brand narratives to life across print, digital, and training platforms. Founded by marketers, for marketers, we pride ourselves on delivering thoughtful, intuitive, and beautifully executed work. Our team is full of “A-teamers”: curious, collaborative, detail-driven people who care deeply about the craft and the quality of what we create. We believe co-location fuels creativity, alignment, and culture. While we offer flexibility, this role is intended for someone who can work 3 days onsite in our Cherry Hill, NJ office and 2 days remote. Senior Editorial and Quality Lead (Healthcare Agency)| Boutique Life Sciences Agency Location: US-Cherry Hill, NJ Employment Type: Full-time Benefits: Health Insurance Compensation, 401K program, Paid time off, and company holidays Opportunity Overview Breaking Data seeks a meticulous Senior Editorial and Quality Lead to serve as the central hub for editorial excellence across pharmaceutical and healthcare deliverables. This hands-on role owns quality control from post-writing drafts through design, reviews, and client approvals-focusing on grammar, style mastery, layout accuracy, and workflow efficiency. Ideal for an experienced editor passionate about the craft of editing. About the Role The Senior Editorial and Quality Lead will own editorial quality control as the central hub across all deliverables-from post-medical writing drafts through design layouts, internal strategy reviews, and client approvals. This hands-on role encompasses proofreading, light editing, layout verification, and workflow coordination for slides, print materials, digital assets, training modules, and long-form content, serving pharmaceutical and healthcare clients. Work closely with medical writers, designers, strategists, and account teams to ensure grammar, style, accuracy, and layout integrity meet the highest agency and client standards. Key Responsibilities Editorial Quality Control Proofread and edit copy developed by medical writers for grammar, clarity, consistency, spelling, accuracy, AMA Manual of Style, and client-specific guidelines. Verify references, superscripts, citations, medical terminology, numeric values, units, symbols, and data formatting. Perform light editing or rewrites to address minor issues and maintain project efficiency. Brand & Compliance Consistency Ensure content aligns with each client's editorial style, tone, branding expectations, and regulatory requirements (including PI/ISI placement when applicable). Confirm correct application of references, anchors, superscripts, and citation formatting. Design & Layout Review Review designed documents and slides (PowerPoint, InDesign, PDFs) to confirm clean, consistent formatting and layout. Verify alignment between copy and design elements (tables, charts, visuals, callouts); identify inconsistencies in spacing, bullets, alignment, superscripts, or content order that could alter meaning. Process & Workflow Execution Manage editorial checkpoints and coordinate handoffs across medical writers, designers, internal strategy reviewers, and clients on multiple concurrent projects. Implement QC edits directly; track and ensure all internal, client, and MLR feedback is accurately incorporated with proper version control and file naming. Serve as the final quality assurance step before client delivery. Requirements Minimum 4-5 years of editorial or proofreading experience in a healthcare, pharmaceutical, or medical communications agency setting. Strong knowledge of the AMA Manual of Style and the ability to apply client-specific style guides and branding requirements. Experience reviewing healthcare or scientific content with a high level of accuracy for terminology, data, units, and references. Demonstrated ability to manage multiple projects and deadlines in a fast-paced, detail-oriented environment. Proficiency in Microsoft Office, Adobe Acrobat Pro, and cloud-based document systems (eg, SharePoint/OneDrive). Exceptional attention to detail and a commitment to editorial precision and quality control. Strong communication and collaboration skills for working with medical writers, designers, strategists, and account teams. Education Bachelor's degree in English, Communications, Journalism, or a related field; a life sciences background is a plus but not required for this role. Work environment Our Cherry Hill, NJ office offers a flexible and collaborative environment. We align projects with each team member's core skills, striking a balance between fun and efficiency to achieve our goals and those of our clients. This is a hybrid position, with 3 days onsite and 2 days remote. Application Process To apply, please submit your resume (and, if available, editing samples) directly through this LinkedIn job posting. Candidates selected for the next steps will be asked to complete a brief editing exercise.

Quality Control Supervisor Our client, a leading biopharmaceutical company, is seeking an experienced Quality Control Supervisor to join their team. This role is responsible for overseeing QC operations in a GMP-regulated environment, ensuring compliance with regulatory standards and internal procedures. Key Responsibilities: Supervise and mentor QC analysts; provide technical guidance and support. Ensure compliance with cGMP, USP, and 21 CFR Parts 210 & 211. Review and approve analytical data, investigations, and CAPAs. Troubleshoot analytical instruments (HPLC, GC, PSD) and support method validation and transfers. Manage testing schedules for raw materials, finished products, stability, and validation samples. Qualifications: BS in a scientific discipline with 5+ years of experience or MS with 3+ years. Hands-on experience with HPLC and Empower software. Strong knowledge of cGMP, USP, and ICH guidelines. Supervisory experience required. This is an excellent opportunity to join a growing organization and make an impact, please apply in directly for more information!

Core Hours: Monday - Friday, 8:00 am - 5:00 pm Purpose and Scope Provide direct supervision of a team of analysts responsible for the testing and release of Tolmar products in support of manufacturing timelines. Essential Duties & Responsibilities Prioritize workload to meet timelines while ensuring on-time delivery of all projects, testing and action items. Take ownership of tasks and results from initiation to completion to meet commitments and proactively address outcomes. Escalate and communicate items which arise per the timelines specified in the department escalation strategy. Execute all business and department goals and initiatives on time. Ensure adherence for compliance with all processes and procedures including training completions, QE and CAPA due dates, notebook and logbook audits, archiving, schedules, internal assessments. Issue all Certificates of Analysis within 2 business days of last test completion. Generate, monitor and report weekly team and analyst KPIs. Supervise the testing and release of Tolmar products, cleaning samples, EM, Bioburden, Endotoxin, raw materials, and stability samples. Strive to balance workload across all sites and teams to ensure adequate resource allocation. Partner with the scheduler to schedule all testing and reviews, review the weekly schedule and ensure company and department targets are met in the shortest possible cycle time. Provide assistance, training and leadership for direct reports through utilization of the OTD resources. Create, revise and monitor training progress utilizing training matrices for immediate functional areas, and collaborate with team on remediation of training gaps for site training matrix. Set and communicate clear expectations for analysts including providing regular feedback and coaching, monitoring progress and fostering employee development to align individual and team performance with organization goals. Create and revise developmental plans to help employees grow their skills and advance their careers. Monitor and discuss progress of employee's performance, growth and development in one on ones utilizing the career ladder and KPIs. Establish sample priorities for QC scheduler, submit schedule tickets as needed and ensure adherence to ship dates. Partner with the investigations team and the scheduler to ensure all actions for QEs are completed in 24 hours, second analyst testing is completed in less than 5 business days and QEs are closed on time (less than 45 business days). Support and execute all potential 3-day field alert investigations and actions expeditiously. Submit document change requests for all document updates and minimize document revisions for routine updates where possible. Ensure all samples logged into the LIMS system are submitted correctly. Identify, and complete cost savings initiatives and facilitate continuous improvement. Participate in leadership development activities and take an active role during department and company activities. Aid in setting procedure and ensure that all operations and functions (including the laboratory) are in full FDA, cGMP compliance and staff is properly trained. Utilize senior analysts to assist in training, document updates, laboratory investigations, projects, or advanced technical issues. Conduct and coordinate laboratory investigations, and all associated actions. Review and approve technical reports, test methods, specifications and procedural documents and ensure overall validity of the analytical results and review stability reports. Participate in project teams, company and department meetings, third party audits, and regulatory audits. Monitor departmental spending to stay within the established budget. Demonstrate leadership aptitude in technical functions and people management. Ability to perform designated duties under minimal supervision and support departmental management in all aspects of organizational functions. Accountable for maintaining an atmosphere of teamwork, cordiality and respect towards co-workers. Accountable for meeting departmental and compliance timelines. Participate in required annual hazardous waste training. Hazardous waste involvement may include, but is not limited to, container and tank management and inspections, generation of hazardous waste as a part of production or sampling processes and transfer of hazardous waste between lab procedure area, satellite accumulation and storage. Respond to spills per the Chemical Spill Procedures. Participate in the interview and selection process for candidates, as required. Perform other duties as required by business demands. Knowledge, Skills & Abilities Possesses a strong sense of purpose and drive to meet deadlines without sacrificing quality. Balances the need for speed with a commitment to accuracy and quality, completing tasks thoughtfully and effectively Expert knowledge in analytical testing of drug substances and formulations for Chemistry or Microbiology. Ability to perform designated duties under minimal supervision and support departmental management in all aspects of organizational functions. Proficient with computer systems for sample tracking, laboratory equipment, raw data handling and storage. Knowledge in analytical method validation and instrument qualification. Thorough knowledge of government regulations of drugs and medical devices as they apply to laboratory work. Technical leadership when working on complex problems within a technical scope in which analysis of situations or data requires an in-depth evaluation of various factors. Exceptional interpersonal and organizational skills that lead directly to the advancement of others and of the QC department. Ability to supervise a team of analytical professionals that is fully compliant with current Good Manufacturing Practices. Knowledge of analytical troubleshooting and product investigation. Effective oral and written communication. Proficient in the use of analytical laboratory instruments such as HPLC, FTIR, GPC, GC, and UV-Vis spectrophotometers, CCIT, Endotoxin, MODA,. Ability to prepare, review, conduct and assess analytical method validations, feasibility and suitable for use. Ability to coordinate activities to assure customers' needs are met in terms of sample analysis cycle time. Core Values The Quality Control Supervisor is expected to operate within the framework of Tolmar's Core Values: Center on People: We commit to support the well-being of our patients. We are committed to treating our employees and those we serve as valued partners. By placing people at the heart of our actions, we actively engage, invigorate, acquire knowledge, and grow together. Are Proactive & Agile: We embody a culture of engagement and action. With a hands-on approach, we fearlessly adapt to change. We anticipate, respond swiftly and efficiently to ignite a spirit that propels us towards extraordinary outcomes. Act Ethically: We are committed to consistently conducting our business in an ethical, compliant, and socially aware manner, in line with our purpose of positively impacting lives. We actively cultivate diversity, equity, inclusion & sustainability in our workplace. Constantly Improve: We are committed to a collaborative & proactive effort to improve our products, systems, processes, and services by reducing waste, increasing efficiency & improving quality. Are Accountable: We think, act, and communicate with honesty, transparency, and clarity in alignment with our core values. We don't compromise our values for near term gain. We take accountability & ownership of our work, actions, successes, and setbacks. We strive to deliver our best as we shape the future. Education & Experience Bachelor's degree in science, preferably in Chemistry or Biochemistry, or Microbiology. Six or more years' experience in an analytical laboratory environment with at least five years in a pharmaceutical GMP setting. Supervisory or team lead experience is preferred. Working Conditions Laboratory setting. Will be exposed to solvents, bio-hazardous materials, hazardous waste, and pharmaceuticals. Must be adaptable to shifting priorities and operate with a sense of urgency while maintaining high quality to meet important timelines in a high throughput lab. Business demands present a need to work extended hours. On call weekend support will be required with a minimum of 8 on call weekends each year. Compensation and Benefits Annual pay range $100,000 - $105,000 depending on experience Bonus Eligible Benefits information: careers/employee-benefits Tolmar compensation programs are focused on equitable, fair pay practices including market-based base pay and a strong benefits package. The final compensation offered may vary from the posted range based on the selected candidates qualifications and experience. Tolmar is an Equal Opportunity Employer. We do not discriminate on the basis age 40 and over, color, disability, gender identity, genetic information, military or veteran status, national origin, race, religion, sex, sexual orientation or any other applicable status protected by state or local law. It is our intention that all qualified applicants be given equal opportunity and that selection decisions are based on job-related factors. Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor.

#LI-Remote This is a field-based and remote opportunity supporting key accounts in Austin, Abilene, Bryan College Station, Midland/Odessa, Temple, Waco and the surrounding area. Novartis is unable to offer relocation support for this role. Please only apply if this location is accessible for you. Company will not sponsor visas for this position. As the Radioligand Therapy Oncology Specialist (RLT), you'll drive demand creation and develop, coordinate, and implement strategic business plans focused on referral and treatment networks of prostate (primary) and neuroendocrine tumor (secondary) customer accounts to further the Radioligand Therapy (RLT) platform for both the diagnostic and therapeutic portfolio. Your focus will be on driving clinical dialog in a sophisticated, multi-stakeholder healthcare professional environment including engagement, coordination, and planning. You will be a partner with Medical Oncologists, Urologists, Nuclear Medicine, and Radiation Oncologists. Job Description Key Responsibilities: Responsible for business ownership of prescribing and referring physicians, while driving relationships and creation and execution of business plans for territories to include delivery of disease education on diagnostic and therapeutic, product value propositions, treatment protocols and implementing customer programs as appropriate. Support product access, implement competitive response/pull-through strategies, maintain and grow key relationships with account partners in line with defined target priorities in a manner consistent and compliant with company policies and requirements. Develop and employ customized tools and strategies to gain appropriate access to engage with HCP targets within territory accounts to deliver clinical value proposition and establish RLT as the partner of choice in community hospital, academic hospitals, and community oncology accounts. Display an elevated level of self-awareness, a passion for learning, an ability to inspire those around you, a willingness to challenge the status-quo and embrace change to optimize execution. Embody a high-level of confidence to deliver messages in a clear and compelling way to customers, optimally handle objections, and close every call with a commitment to action to inspire changes in behavior. Continuously demonstrate deep understanding of territory market landscape, competitors, market segments / dynamics, product, clinical data, and anticipate environmental changes and challenges to optimize execution. Develop and execute a call-plan to achieve goals and improve access and sales opportunities, while promoting a highly technical and innovative product portfolio to a sophisticated audience. Comfort in using sales data reporting tools to understand trends and coupling with customer insights to identify territory and customer growth opportunities in a constantly evolving environment. Essential Requirements: Bachelor's degree required, advanced degree a plus. 3+ years' experience in specialty pharmaceuticals, biotech, or a sales role of similar complexity within the last 5 years. 1+ years' experience in oncology, urology, nuclear medicine, medical devices, or complex therapeutics. 1+ years' experience in prostate, NET or buy-and-bill therapeutic experience, within last 5 years. Strong ability to collaborate, work cross-functionally within a matrix environment, can communicate clinical product information, has a validated track-record of consistent high-performance, and is proficient in navigating and successfully selling to large accounts and key customer segments. Self-starter with analytic abilities to seek out, prioritize, and apply relevant information to solve problems to meet the needs of key customers, while also demonstrating ethical leadership and ability to champion an environment that promotes ethical behavior and compliance with company policies & laws. Candidate must reside within territory, or within a reasonable daily commuting distance of 50 miles from the territory border. Ability to travel 60-80% over a broad geography is required, with the ability to drive and/or fly within the territory. Must have a valid driver's license. Desirable Requirements: Experience with multiple product launches. Driving is an Essential Function of this Role: Meaning it is fundamental to the purpose of this job and cannot be eliminated. Because driving is an essential function of the role, you must have a fully valid and unrestricted driver's license to be qualified for this role. The company provides reasonable accommodations for otherwise qualified individuals with medical restrictions if an accommodation can be provided without eliminating the essential function of driving. COVID-19 Vaccine Policy (customer-facing roles only): While Novartis does not require vaccination for COVID-19 or proof of a recent negative test result for COVID-19 at this time, employees working in customer-facing roles must adhere to and comply with customers' (such as hospitals, physician offices, etc.) credentialing guidelines, which may require vaccination. As required by applicable law, Novartis will consider requests for reasonable accommodation for those unable to be vaccinated. This requirement is subject to applicable state and local laws and may not be applicable to employees working in certain jurisdictions. Please send accommodation requests to . For Field Roles with a Dedicated Training Period: The individual hired for this role will be required to successfully complete certain initial training, including home study, eight (8) or fewer hours per day and forty (40) or fewer hours per week. Novartis Compensation Summary: The salary for this position is expected to range between $151,200 and $226,800 per year. The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors. Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards. US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves. EEO Statement: The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. Accessibility and reasonable accommodations The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please send an e-mail to or call and let us know the nature of your request and your contact information. Please include the job requisition number in your message. Salary Range $145,600.00 - $270,400.00 Skills Desired Accountability, Account Management, Commercial Excellence, Competitive Intelligence, Compliance, Crm (Customer Relationship Management), Customer Engagement, Ethics, Healthcare Sector, Market Development, Problem Solving Skills, Process Knowledge, Revenue Growth, Selling Skills, Team Collaboration, Value Propositions

Octapharma Plasma offers professional opportunities that make a meaningful difference. We enhance the lives of patients who need our life-saving medicines. We reward the donors who provide the plasma we collect to make them. And we inspire growth and development in the teams at our donation centers, offices, and labs. We invite you to do the same in this role: Onboarding Specialist This Is What You'll Do: Plan and coordinate the logistics of new employee onboarding, including scheduling and preparing materials. Conduct orientation sessions to introduce new hires to the company's culture, values, policies and procedures. Schedule and coordinate onboarding activities, providing guidance and support to new hires throughout the process. Ensuring completion of paperwork and following all legal and administrative compliance when onboarding candidates. Assist new hires with completing the necessary paperwork, including employee forms, benefits enrolment, and IT setup. Processes I-9 and E-Verify requests. Processes background checks and drug screens. This Is Who You Are: Excellent interpersonal skills, strong written and verbal communication skills. Highly ambitious and ability to think outside of the box. Eager to share new ideas and contribute to a team. Self-motivated and willing to assume the initiative. Attentive to every detail. Capable of thriving while working independently. This Is What It Takes: 2+ years of experience in onboarding and recruitment with a proven track record of successful onboarding processes and employee retention. Strong knowledge of onboarding best practices, HR policies and procedures, and employment laws and regulations to ensure compliance during the onboarding process. Strong organizational skills to manage and streamline the onboarding process efficiently. Excellent communication and interpersonal skills to build rapport with new employees and establish a positive onboarding experience. Attention to detail and organizational skills to coordinate and manage multiple onboarding processes simultaneously. Adaptability and flexibility to accommodate the diverse needs and backgrounds of new employees. Ability to collaborate and work effectively with remote team members with prior experience in corporate onboarding. Proficiency in Microsoft Office Suite. Proficiency in using HRIS systems and experience with different applicant tracking systems. May require travel to assist field locations with recruitment. We're widely known and respected for our benefits and for leadership that is supportive and hands-on. Formal training Outstanding plans for medical, dental, and vision insurance Health savings account (HSA) Employee assistance program (EAP) Wellness program 401 (k) retirement plan Paid time off Company-paid holidays Personal time More About Octapharma Plasma, Inc. With donation centers and team members throughout the U.S., Octapharma Plasma, Inc. collects plasma to create life-saving medicines for patients worldwide. We are growing at an impressive pace, and so is the positive impact of our work. Our community relies on teamwork, compassion, and expertise to get things done the right way, while making a meaningful difference in the lives we touch. INNER SATISFACTION. OUTSTANDING IMPACT.

States Considered: Texas Role Description The US Equine business focuses on delivering maximum value to customers through portfolio solutions and strong partnerships. Zoetis provides more than medicines and services-we support customers through: A direct sales field force Aligned technical services teams Valueadded solutions that differentiate us from competitors The Equine Specialist manages the Zoetis Equine business with distributors, veterinarians, dealers, and horse owners within the assigned territory. A strong understanding of the equine market and its dynamics is highly advantageous. This role requires travel and overnight stays. Position Responsibilities Call on Equine and Mixed Animal Veterinarians, Dealers, and Distributor Representatives Quantify and qualify differences among Zoetis products and competitor products Utilize strong presentation skills to conduct educational training and producer seminars Build relationships and influence within key trade channels, including: Veterinarians Distributors OTC dealers Farm personnel University personnel Work closely with Equine distribution partners to drive sales results Manage a broad geographic area with a diverse customer base to achieve sales targets and business objectives Build trust with customers through reliability, credibility, and consistent followup Conduct territory planning and priority setting through data analysis, resource utilization, and execution of business plans Maintain technical and commercial knowledge, including: General equine industry knowledge Indepth Zoetis product knowledge Business and financial acumen of the local customer base Demonstrate teamwork by sharing, collaborating, and acting as a team player Perform other duties and responsibilities as assigned Education & Experience Undergraduate degree (BS/BA) required; equivalent experience considered A master's in Animal Science or a related field is a plus Minimum experience requirements: Associate Equine Specialist: 6+ months of equinerelated experience Equine Specialist: 2+ years of equinerelated experience Senior Equine Specialist: 8+ years of equinerelated experience Animal health experience and equine industry knowledge preferred Ability and willingness to travel overnight at least 50% of the time, including some weekends Technical Skill Requirements Indepth product and disease knowledge Excellent written and oral communication skills Proficiency in PowerPoint, Excel, and Word Physical Position Requirements Valid driver's license required Willingness to drive to customer locations across the defined geography (horse, clinic, and dealer facilities) Ability to work on equine farms Willingness to work with animals, including husbandry, treatment administration, and product administration education Full time RegularColleague Any unsolicited resumes sent to Zoetis from a third party, such as an Agency recruiter, including unsolicited resumes sent to a Zoetis mailing address, fax machine or email address, directly to Zoetis employees, or to Zoetis resume database will be considered Zoetis property. Zoetis will NOT pay a fee for any placement resulting from the receipt of an unsolicited resume. Zoetis will consider any candidate for whom an Agency has submitted an unsolicited resume to have been referred by the Agency free of any charges or fees. This includes any Agency that is an approved/engaged vendor but does not have the appropriate approvals to be engaged on a search. Zoetis 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 or any other protected classification. Disabled individuals are given an equal opportunity to use our online application system. We offer reasonable accommodations as an alternative if requested by an individual with a disability. Please contact Zoetis Colleague Services at to request an accommodation. Zoetis also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must possess or obtain authorization to work in the US for Zoetis. Zoetis retains sole and exclusive discretion to pursue sponsorship for the acquisition or maintenance of nonimmigrant status and employment eligibility, considering factors such as availability of qualified US workers. Individuals requiring sponsorship must disclose this fact. Please note that Zoetis seeks information related to job applications from candidates for jobs in the U.S. solely via the following: (1) our company website at ********************** site, or (2) via email to/from addresses using only the Zoetis domain of "@zoetis.com". In addition, Zoetis does not use Google Hangout for any recruitment related activities. Any solicitation or request for information related to job applications with Zoetis via any other means and/or utilizing email addresses with any other domain should be disregarded. In addition, Zoetis will never ask candidates to make any type of personal financial investment related to gaining employment with Zoetis.

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

Nature and Scope Ensures quality system compliance with GMPs, procedures and documentation within the company and in keeping with the internal audit program. Interacts with all levels of the organization and maintains on-going dialogue with management. Essential Duties and Responsibilities Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time. Under supervision, assist with documentation for the closure of investigations. Assist in gathering data for reports, metrics, Annual Product reviews, Quarterly reports and external requests. Scheduling departmental meetings, maintaining meeting minutes and attendance. Maintain departmental records and files (both electronic and manual). Participate in cross-functional project teams as required. Support, coordinate, and assist with regulatory agency audit tasks as required in support of regulatory agency inspections. Support and maintain quality programs, policies, processes, procedures and controls ensuring compliance with current Good Manufacturing Practices (cGMP). Keep training curriculum current. Ensure all work is performed and documented in accordance with existing company policies and procedures. Perform any other tasks/duties as assigned by management. Education Requirements and Qualifications To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required. High School or GED diploma required. Associate's degree or equivalent years of experience preferred. Experience working in a Quality role within a cGMP manufacturing environment required. Knowledge and understanding of quality assurance principles, controls and interactions between Quality Systems; FDA guidance, ICH, PIC/S, etc. Strong attention to detail, adherence to SOPs. Ability to work effectively in a collaborative environment. Ability to effectively work under dynamic constraints, with success in managing multiple activities concurrently and producing outstanding results. Strong organizational, interpersonal and communication skills (oral and written). Written skills must be audit-level appropriate for non-routine or complex issues. PC Skills Required (MS Word, Excel). Ability to work overtime as needed. Physical Environment and Requirements Physically able to wear cleanroom/protective gowning and equipment, including but not limited to gowning, goggles, face shields, and protective gloves. PPE is essential for the health and safety of employees. Expected Salary Range: $70,100 - $85,000 The salary range, displayed is the minimum and maximum annual salary range of compensation for the role that the employer in good faith believes to be accurate at the time of the posting of an advertisement for the role. Actual compensation for the role will be based on a number of different factors including but not limited to the candidate's qualifications, education, knowledge, skills and experience. American Regent also offers a competitive total rewards package which includes healthcare, life insurance, profit sharing, paid time off, matching 401k as well as a wide range of other benefits. American Regent celebrates diversity and we are committed to creating an inclusive environment for all employees. We are an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, or protected veteran status. Applicants have rights under Federal Employment Laws. FMLA poster: ********************************************************** Know Your Rights: Know Your Rights: Workplace discrimination is illegal (eeoc.gov) Employee Polygraph Protection Act: ********************************************************* Alert: We're aware of individuals impersonating our staff to target job seekers. Please note: · All legitimate communication will come directly from a verified ARI recruiter either by phone or via an americanregent.com email address. · Our recruiting process includes multiple in person and/or video interviews and assessments. · If you are unsure about the legitimacy of a message, contact John Rossini at *************************** before responding. · We never request payment, bank information, or personal financial details during our offer process. Your security is important to us, and we encourage you to stay vigilant when job searching. American Regent Inc. endeavors to make *********************************** accessible to any and all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please email **************************************.

Nature and Scope The QA Specialist - Deviations will be responsible for effectively ensuring non-routine events are investigated and documented in accordance with company SOPs, policies and cGMPs. This is a cross-functional position that interacts with all departments at American Regent. Ensures quality system compliance with GMPs, procedures and documentation within the company and in keeping with regulatory requirements and company procedures. The role is responsible for authoring, reviewing, and providing the final Quality approval for investigations into manufacturing and laboratory events/deviations. The role interacts with all levels of the organization and is expected to use professional judgment in appropriate issue escalation to management. Essential Duties and Responsibilities Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time. Ensures any non-routine events associated with the manufacture of safe, pure, and effective sterile pharmaceuticals are investigated and documented in accordance with company SOPs, policies and cGMPs and within assigned timelines. Identify trends, evaluate metrics, and provide support for internal audits under the direction of the QA Deviations Supervisor. Ensure deviation timelines are maintained through inter-department communication. Facilitate and lead assigned investigations involving multiple investigation areas. Facilitate and participate in initiatives to address compliance gaps identified during investigations with minimal assistance. Provide quality system level assessments and reviews, author and facilitate change requests. Initiate and complete or assign investigations and CAPAs related to Quality departments (Quality Operations, Quality Control, Quality Systems). Perform and guide root-cause analysis for events utilizing investigation tools (e.g., 5 whys, 6M, Fishbone Diagrams). Perform the QA review and final approval signature for assigned deviations/events, confirming the completeness, accuracy, and consistency of all work so that it meets the standards of quality. Identify errors and inconsistencies and initiate resolution to ensure high quality. Coordinate/provide oversight for the investigations system, including follow up with cross-functional stakeholders (assignees, internal customers, reviewers, and approvers). Act as a liaison between Operations and Quality in all matters related to investigations and CAPA. Under supervision assist with documentation for the closure of complaint investigations. Gather data for reports, metrics, Annual Product reviews and external requests. Generate and analyze metrics as assigned, employing statistical techniques as appropriate. Scheduling departmental meetings, maintaining meeting minutes and attendance. Maintain departmental records and files (both electronic and manual). Participate in cross-functional project teams as required. Support, coordinate, and assist with regulatory agency audits and inspections as required. Support and maintain quality programs, policies, processes, procedures, and controls ensuring compliance with current Good Manufacturing Practices (cGMP). Keep training curriculum current in ISO train. Ensure all work is performed and documented in accordance with existing company policies and procedures. Perform any other tasks/duties as assigned by management. Education Requirements and Qualifications To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required. Bachelor's degree in a science or engineering field. ASQ Certification as a Quality Engineer or Six Sigma Black belt preferred. Minimum of 2-5 years of experience working in a Quality role within a cGMP manufacturing environment required. Knowledge and understanding of quality assurance principles, controls, and interactions between Quality Systems; FDA guidance, ICH, PIC/S, etc. Strong attention to detail, adherence to SOPs. Ability to work effectively in a collaborative environment. Ability to effectively work under dynamic constraints, with success in managing multiple activities concurrently and producing outstanding results. Strong organizational, interpersonal and communication skills (oral and written). Written skills must be audit-level appropriate for non-routine or complex issues. Ability to apply critical thinking to scientific problems and demonstrated knowledge. Ability to apply statistical quality management concepts. PC Skills Required (MS Word, Excel). Preference will be given to candidates with demonstrated knowledge of Quality software such as TrackWise, Veeva and Minitab. Excellent English communication skills, both oral and written, and comprehension are required. Ability to effectively present information to top management, employees, or customers. Physical Environment and Requirements Physically able to wear cleanroom/protective gowning and equipment, including but not limited to gowning, goggles, face shields, and protective gloves. PPE is essential for the health and safety of employees. Expected Salary range: $79,900-$85,000 The salary range displayed is the minimum and maximum salary range for the role that the employer in good faith believes to be accurate at the time of the posting of an advertisement for the role. Actual compensation for the role will be based on a number of different factors including but not limited to the candidate's qualifications, education, knowledge, skills and experience. American Regent also offers a competitive total rewards package which includes healthcare, life insurance, profit sharing, paid time off, matching 401k as well as a wide range of other benefits. American Regent celebrates diversity and we are committed to creating an inclusive environment for all employees. We are an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, or protected veteran status. Applicants have rights under Federal Employment Laws. FMLA poster: ********************************************************** Know Your Rights: Know Your Rights: Workplace discrimination is illegal (eeoc.gov) Employee Polygraph Protection Act: ********************************************************* Alert: We're aware of individuals impersonating our staff to target job seekers. Please note: · All legitimate communication will come directly from a verified ARI recruiter either by phone or via an americanregent.com email address. · Our recruiting process includes multiple in person and/or video interviews and assessments. · If you are unsure about the legitimacy of a message, contact John Rossini at *************************** before responding. · We never request payment, bank information, or personal financial details during our offer process. Your security is important to us, and we encourage you to stay vigilant when job searching. American Regent Inc. endeavors to make *********************************** accessible to any and all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please email **************************************.

Nature and Scope The QA Specialist - Deviations will be responsible for effectively ensuring non-routine events are investigated and documented in accordance with company SOPs, policies and cGMPs. This is a cross-functional position that interacts with all departments at American Regent. Ensures quality system compliance with GMPs, procedures and documentation within the company and in keeping with regulatory requirements and company procedures. The role is responsible for authoring, reviewing, and providing the final Quality approval for investigations into manufacturing and laboratory events/deviations. The role interacts with all levels of the organization and is expected to use professional judgment in appropriate issue escalation to management. Essential Duties and Responsibilities Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time. * Ensures any non-routine events associated with the manufacture of safe, pure, and effective sterile pharmaceuticals are investigated and documented in accordance with company SOPs, policies and cGMPs and within assigned timelines. Identify trends, evaluate metrics, and provide support for internal audits under the direction of the QA Deviations Supervisor. * Ensure deviation timelines are maintained through inter-department communication. * Facilitate and lead assigned investigations involving multiple investigation areas. * Facilitate and participate in initiatives to address compliance gaps identified during investigations with minimal assistance. Provide quality system level assessments and reviews, author and facilitate change requests. * Initiate and complete or assign investigations and CAPAs related to Quality departments (Quality Operations, Quality Control, Quality Systems). * Perform and guide root-cause analysis for events utilizing investigation tools (e.g., 5 whys, 6M, Fishbone Diagrams). * Perform the QA review and final approval signature for assigned deviations/events, confirming the completeness, accuracy, and consistency of all work so that it meets the standards of quality. Identify errors and inconsistencies and initiate resolution to ensure high quality. * Coordinate/provide oversight for the investigations system, including follow up with cross-functional stakeholders (assignees, internal customers, reviewers, and approvers). Act as a liaison between Operations and Quality in all matters related to investigations and CAPA. * Under supervision assist with documentation for the closure of complaint investigations. * Gather data for reports, metrics, Annual Product reviews and external requests. Generate and analyze metrics as assigned, employing statistical techniques as appropriate. * Scheduling departmental meetings, maintaining meeting minutes and attendance. * Maintain departmental records and files (both electronic and manual). * Participate in cross-functional project teams as required. * Support, coordinate, and assist with regulatory agency audits and inspections as required. * Support and maintain quality programs, policies, processes, procedures, and controls ensuring compliance with current Good Manufacturing Practices (cGMP). * Keep training curriculum current in ISO train. * Ensure all work is performed and documented in accordance with existing company policies and procedures. * Perform any other tasks/duties as assigned by management. Education Requirements and Qualifications To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required. * Bachelor's degree in a science or engineering field. * ASQ Certification as a Quality Engineer or Six Sigma Black belt preferred. * Minimum of 2-5 years of experience working in a Quality role within a cGMP manufacturing environment required. * Knowledge and understanding of quality assurance principles, controls, and interactions between Quality Systems; FDA guidance, ICH, PIC/S, etc. * Strong attention to detail, adherence to SOPs. * Ability to work effectively in a collaborative environment. * Ability to effectively work under dynamic constraints, with success in managing multiple activities concurrently and producing outstanding results. * Strong organizational, interpersonal and communication skills (oral and written). Written skills must be audit-level appropriate for non-routine or complex issues. * Ability to apply critical thinking to scientific problems and demonstrated knowledge. * Ability to apply statistical quality management concepts. * PC Skills Required (MS Word, Excel). Preference will be given to candidates with demonstrated knowledge of Quality software such as TrackWise, Veeva and Minitab. * Excellent English communication skills, both oral and written, and comprehension are required. Ability to effectively present information to top management, employees, or customers. Physical Environment and Requirements * Physically able to wear cleanroom/protective gowning and equipment, including but not limited to gowning, goggles, face shields, and protective gloves. PPE is essential for the health and safety of employees. Expected Salary range: $79,900-$85,000 The salary range displayed is the minimum and maximum salary range for the role that the employer in good faith believes to be accurate at the time of the posting of an advertisement for the role. Actual compensation for the role will be based on a number of different factors including but not limited to the candidate's qualifications, education, knowledge, skills and experience. American Regent also offers a competitive total rewards package which includes healthcare, life insurance, profit sharing, paid time off, matching 401k as well as a wide range of other benefits. American Regent celebrates diversity and we are committed to creating an inclusive environment for all employees. We are an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, or protected veteran status. Applicants have rights under Federal Employment Laws. * FMLA poster: ********************************************************** * Know Your Rights: Know Your Rights: Workplace discrimination is illegal (eeoc.gov) * Employee Polygraph Protection Act: ********************************************************* Alert: We're aware of individuals impersonating our staff to target job seekers. Please note: * All legitimate communication will come directly from a verified ARI recruiter either by phone or via an americanregent.com email address. * Our recruiting process includes multiple in person and/or video interviews and assessments. * If you are unsure about the legitimacy of a message, contact John Rossini at *************************** before responding. * We never request payment, bank information, or personal financial details during our offer process. Your security is important to us, and we encourage you to stay vigilant when job searching. American Regent Inc. endeavors to make *********************************** accessible to any and all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please email **************************************.

Nature and Scope Ensures quality system compliance with GMPs, procedures and documentation within the company and in keeping with the internal audit program. Interacts with all levels of the organization and maintains on-going dialogue with management. Essential Duties and Responsibilities Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time. * Under supervision, assist with documentation for the closure of investigations. * Assist in gathering data for reports, metrics, Annual Product reviews, Quarterly reports and external requests. * Scheduling departmental meetings, maintaining meeting minutes and attendance. * Maintain departmental records and files (both electronic and manual). * Participate in cross-functional project teams as required. * Support, coordinate, and assist with regulatory agency audit tasks as required in support of regulatory agency inspections. * Support and maintain quality programs, policies, processes, procedures and controls ensuring compliance with current Good Manufacturing Practices (cGMP). * Keep training curriculum current. * Ensure all work is performed and documented in accordance with existing company policies and procedures. * Perform any other tasks/duties as assigned by management. Education Requirements and Qualifications To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required. * High School or GED diploma required. Associate's degree or equivalent years of experience preferred. * Experience working in a Quality role within a cGMP manufacturing environment required. * Knowledge and understanding of quality assurance principles, controls and interactions between Quality Systems; FDA guidance, ICH, PIC/S, etc. * Strong attention to detail, adherence to SOPs. * Ability to work effectively in a collaborative environment. * Ability to effectively work under dynamic constraints, with success in managing multiple activities concurrently and producing outstanding results. * Strong organizational, interpersonal and communication skills (oral and written). Written skills must be audit-level appropriate for non-routine or complex issues. * PC Skills Required (MS Word, Excel). * Ability to work overtime as needed. Physical Environment and Requirements * Physically able to wear cleanroom/protective gowning and equipment, including but not limited to gowning, goggles, face shields, and protective gloves. PPE is essential for the health and safety of employees. Expected Salary Range: $70,100 - $85,000 The salary range, displayed is the minimum and maximum annual salary range of compensation for the role that the employer in good faith believes to be accurate at the time of the posting of an advertisement for the role. Actual compensation for the role will be based on a number of different factors including but not limited to the candidate's qualifications, education, knowledge, skills and experience. American Regent also offers a competitive total rewards package which includes healthcare, life insurance, profit sharing, paid time off, matching 401k as well as a wide range of other benefits. American Regent celebrates diversity and we are committed to creating an inclusive environment for all employees. We are an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, or protected veteran status. Applicants have rights under Federal Employment Laws. * FMLA poster: ********************************************************** * Know Your Rights: Know Your Rights: Workplace discrimination is illegal (eeoc.gov) * Employee Polygraph Protection Act: ********************************************************* Alert: We're aware of individuals impersonating our staff to target job seekers. Please note: * All legitimate communication will come directly from a verified ARI recruiter either by phone or via an americanregent.com email address. * Our recruiting process includes multiple in person and/or video interviews and assessments. * If you are unsure about the legitimacy of a message, contact John Rossini at *************************** before responding. * We never request payment, bank information, or personal financial details during our offer process. Your security is important to us, and we encourage you to stay vigilant when job searching. American Regent Inc. endeavors to make *********************************** accessible to any and all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please email **************************************.

ABOUT LCI The mission of LCI is to provide meaningful employment for the blind and visually impaired. We accomplish this in four ways: EMPLOY: We are one of the largest employers of people who are blind, creating meaningful careers and lasting skills that transform their lives. BUILD: We create over 2,000 products and distribute thousands more through manufacturing, retail, nationwide distribution, and e-commerce channels. SERVE: Many of our products are sold directly to the federal government. We were pioneers of “base supply centers,” stores on military bases that employ the blind and visually impaired and provide mission-critical supplies to our nation's military. SUPPORT: We want to end blindness forever. To that end, we engage in philanthropic efforts for research into blindness and treatment for the visually impaired. ABOUT THIS ROLE The Specialist, Quality Assurance is responsible for performance of Batch Record Review and Disposition function for LCI. Within that function, assure compliance with laws and regulations and in a manner consistent with best practices and applicable guidance. Responsible for performing and managing activities related to GMP document review and disposition of commercial products. This includes related activities at third-party contractors including the oversight of validation, change control, investigations and CAPA activities related to LCI products. LOCATION AND SCHEDULE Durham, NC Monday-Friday 7 AM - 3:30 PM KEY RESPONSIBILITIES Batch Review and disposition: Act as primary point of contact with third-party contract manufacturers, laboratories, suppliers, etc. to coordinate completion of all third-party records (deviations, CAPA, Change Controls, Complaints, Validation, QC test results, etc.) associated with release of LCI batches. Review and approve Master Batch Records. Perform the review of records and determine disposition of: Medical Devices Packaged/Labeled Medical Devices Clinical Product Investigations and CAPAs. Perform the review of Testing Specifications. Validation Coordinate and monitor validation activities. Provide support during regulatory inspections of GMP Contractors and LCI facilities. Assist in performing inspection readiness activities. Review Quality Agreements. Maintain current understanding of laws & regulations applicable to the pharmaceutical/biotechnology industry. Provide updates to Manager, BioMed Operations. QUALIFICATIONS Bachelor's Degree in a life science-related discipline or equivalent work experience. Minimum of 3 years of GMP quality assurance experience, including hands-on experience in Quality Operations, batch record review, disposition, and/or validation. Experience in working with third-party contract manufacturers, laboratories, and packagers. Knowledge of pharmaceutical industry regulatory requirements. High level of familiarity with practices needed to maintain compliance in the areas of batch record review, disposition, and validation and an ability to assess risk and develop solutions. Ability to exercise strong risk-based business judgment. Ability to collaboratively with a high sense of teamwork across diverse functions, operate independently and build strong networks throughout the corporate organization. Demonstrated ability to work with high integrity and an unwavering commitment to our corporate value of Quality. Works in a transparent and open manner in all aspects of the role and in all aspects of managing partnerships and relationships both internally and externally Good investigation and monitoring skills. Current knowledge of QC testing methods. Attention to detail and implementation of good documentation and GMP processes is essential. Excellent communication skills required and must be computer literate. Ability to effectively communicate with all levels of employees and external business associates, comfortable creating and delivering presentations. Why LCI? Purpose-driven company driven by principles, not profit Reach your highest potential: upward mobility, rewarded through hard work Competitive salary and compensation Basic Life Insurance at no cost to the employee 401(k) with match and Surplus-Sharing Plans Health, Dental, and Vision Insurance Ten paid holidays annually Paid Time Off (PTO) On-site Health and Wellness program Employee Assistance Program (EAP)

The mission of LCI is to provide meaningful employment for the blind and visually impaired. We accomplish this in four ways: * EMPLOY: We are one of the largest employers of people who are blind, creating meaningful careers and lasting skills that transform their lives. * BUILD: We create over 2,000 products and distribute thousands more through manufacturing, retail, nationwide distribution, and e-commerce channels. * SERVE: Many of our products are sold directly to the federal government. We were pioneers of "base supply centers," stores on military bases that employ the blind and visually impaired and provide mission-critical supplies to our nation's military. * SUPPORT: We want to end blindness forever. To that end, we engage in philanthropic efforts for research into blindness and treatment for the visually impaired. ABOUT THIS ROLE The Specialist, Quality Assurance is responsible for performance of Batch Record Review and Disposition function for LCI. Within that function, assure compliance with laws and regulations and in a manner consistent with best practices and applicable guidance. Responsible for performing and managing activities related to GMP document review and disposition of commercial products. This includes related activities at third-party contractors including the oversight of validation, change control, investigations and CAPA activities related to LCI products. LOCATION AND SCHEDULE Durham, NC Monday-Friday 8:30 AM - 5 PM KEY RESPONSIBILITIES * Batch Review and disposition: * Act as primary point of contact with third-party contract manufacturers, laboratories, suppliers, etc. to coordinate completion of all third-party records (deviations, CAPA, Change Controls, Complaints, Validation, QC test results, etc.) associated with release of LCI batches. * Review and approve Master Batch Records. * Perform the review of records and determine disposition of: * Medical Devices * Packaged/Labeled Medical Devices * Clinical Product * Investigations and CAPAs. * Perform the review of Testing Specifications. * Validation * Coordinate and monitor validation activities. * Provide support during regulatory inspections of GMP Contractors and LCI facilities. * Assist in performing inspection readiness activities. * Review Quality Agreements. * Maintain current understanding of laws & regulations applicable to the pharmaceutical/biotechnology industry. * Provide updates to Manager, BioMed Operations. QUALIFICATIONS * Bachelor's Degree in a life science-related discipline or equivalent work experience. * Minimum of 3 years of GMP quality assurance experience, including hands-on experience in Quality Operations, batch record review, disposition, and/or validation. * Experience in working with third-party contract manufacturers, laboratories, and packagers. * Knowledge of pharmaceutical industry regulatory requirements. * High level of familiarity with practices needed to maintain compliance in the areas of batch record review, disposition, and validation and an ability to assess risk and develop solutions. * Ability to exercise strong risk-based business judgment. * Ability to collaboratively with a high sense of teamwork across diverse functions, operate independently and build strong networks throughout the corporate organization. * Demonstrated ability to work with high integrity and an unwavering commitment to our corporate value of Quality. * Works in a transparent and open manner in all aspects of the role and in all aspects of managing partnerships and relationships both internally and externally * Good investigation and monitoring skills. * Current knowledge of QC testing methods. * Attention to detail and implementation of good documentation and GMP processes is essential. * Excellent communication skills required and must be computer literate. * Ability to effectively communicate with all levels of employees and external business associates, comfortable creating and delivering presentations. * Why LCI? * Purpose-driven company driven by principles, not profit * Reach your highest potential: upward mobility, rewarded through hard work * Competitive salary and compensation * Basic Life Insurance at no cost to the employee * 401(k) with match and Surplus-Sharing Plans * Health, Dental, and Vision Insurance * Ten paid holidays annually * Paid Time Off (PTO) * On-site Health and Wellness program * Employee Assistance Program (EAP)

"Expect to grow", personally and professionally: At Siegfried, we offer exciting challenges and ample opportunities to showcase your talents. As a trusted and respected partner to the pharmaceutical industry, we uphold the highest standards in safety, quality and sustainability, while fostering a culture that empowers you to thrive. Join a rapidly expanding global company, where diverse perspectives and experiences come together in a collaborative environment. Here, you'll find a workplace that values both collective success and your individual contributions-offering long-term opportunities to grow and make an impact. Your Role: Scope and Purpose of Position This person will support the QA Department with all Training and Document Control duties. Your Profile: Responsibilities Ensure GMP/ISO compliance in all documentation control activities to meet customer's expectation based on Quality Management System (QMS) requirements. Administrate the local Training System according to site, corporate, and regulatory standards to include: building of required system assets (e.g., training materials, classes, curricula) based on input from the different department management, technical and administrative support to users, processing of completed trainings, management of training records, organization / execution of site training objectives and requirements (e.g., Annual GMP Training), and monitor / report training status. Assist in the administration of Document Control / Document Management System according to site, corporate and regulatory standards to include: processing of document revisions/implementations, periodic review of documents, retrieval and archiving of documents, and security of physical document storage and electronic copies Assist in the management of the Document Control area to ensure security and availability of materials and supplies to accomplish the Document Control mission Assist in the management of the logbook program ensuring timely issuance and reconciliation of logbooks Assist in the maintenance and execute of the filing system for the manufacturing documentation, to include: issuance of batch records, archival of executed batch records, and return of customer owned documents Provide sound Quality guidance and enforcement of Document Control and Training procedures and fundamentals Provide training on Document Control owned and Training systems. Support the Quality Unit during customer and regulatory audits and inspections Any and all other duties as assigned by immediate supervisor. Required Knowledge, Skills and Abilities Understanding of GMP at an academic and conceptual level and adherence at a tactical level Understanding of training fundamentals for effectiveness and compliance Understanding of document control fundamentals Customer service with focus on order and request fulfillment Strong organizational, records/database management, and area housekeeping skills Good computer literacy with particular focus on Windows platform and applications such as Adobe and Office (Word, Excel) Good oral and written business communication Public speaking Ability to lift 15 to 25 lbs. Required Education and Experience Bachelor's Degree or equivalent combination of education and experience 4 years working in a Quality role in a GMP environment / 8 years if previous experience is non-Quality role Your Benefits: Paid Time Off, Health Insurance, Retirement Planning Target Range: $75 - $90K Founded in 1873 in Zofingen, Switzerland, Siegfried has grown into a global network of 13 sites across three continents. With a team of more than 3,800 highly skilled professionals, we take the innovations of our pharmaceutical customers to industrial scale and manufacture safe drugs for patients worldwide. As a fully integrated CDMO, Siegfried is one of the few organizations today that can carry out the development and manufacturing of APIs and finished dosage forms under one roof. This unique combination of know-how and experience makes us the most trusted partner in the pharmaceutical industry.

Description About Orsini Specialty PharmacyProviding compassionate care since 1987, Orsini is a leader in rare disease and gene therapy pharmacy solutions, built to simplify how patients connect to advanced medicines. Through our comprehensive commercialization solutions including a nationwide specialty pharmacy, patient services hub, home infusion and nursing network, and third-party logistics provider, we work with biopharma, providers, and payors to ensure No Patient is Left Behind™. Our MissionOrsini is on a mission to be the essential partner for biopharma innovators, healthcare providers, and payers to support patients and their families in accessing revolutionary treatments for rare diseases. Through our integrated portfolio of services, we seek to pioneer comprehensive solutions that simplify how patients connect to advanced therapies while providing holistic, compassionate care so that No Patient is Left Behind™. LIVE IT ValuesAt the heart of our company culture, the Orsini LIVE IT core values serve as guiding principles that shape how we interact with each other and those we serve. These values are the driving force behind our commitment to excellence, collaboration, and genuine care in every aspect of our work. Leading Quality, Integrity, Valued Partner, Empathy, Innovation, Team-FirstPay Range: $19-$24 HourlyThe Quality Assurance Specialist will be responsible for supporting the Quality Team in carrying out the quality management systems at Orsini, with a primary focus on internal audits and quality checks. This role will assist in monitoring compliance with contracts, regulatory requirements and accreditation standards by performing safety data quality checks and routine audits, documenting findings and supporting corrective actions. The specialist will also provide support with other aspects of the quality system as needed, which may include vendor management, quality metrics, deviation and CAPA tracking, and document control. By assisting in these activities, the specialist helps ensure the provision of optimal pharmaceutical care to patients and clients of Orsini Healthcare. Required Knowledge, Skills & Training • Previous experience in a pharmacy, healthcare quality, or compliance setting required; specialty or mail-order pharmacy experience preferred. • Knowledgeable in electronic medical record systems and able to navigate and review patient charts for accuracy and completeness required • Experience with internal audits or compliance monitoring is preferred. • Familiarity with pharmacovigilance activities, including adverse event reporting and case management, preferred. • Familiarity with pharmacy accreditation standards (URAC, ACHC, or similar) a plus. • Strong computer skills - Microsoft Excel, Word, PowerPoint, and Visio • Strong attention to detail with excellent organizational and documentation skills. • Effective written and verbal communication skills. • Ability to follow structured processes and work independently while collaborating across teams. Essential Job Duties• Review electronic medical records to verify correct reporting and documentation of safety events. • Review electronic medical records and patient charts to identify errors, omissions, or potential compliance issues. • Conducts audit of pharmacovigilance case reports, adverse event documentation and related records to ensure accuracy, completeness, and compliance with contractual obligations • Maintain organized and accurate records of audits, quality checks, and related documentation.• Support other aspects of the quality management system as needed• Special projects as assigned.Employee Benefits BCBSL Medical Delta Dental EyeMed Vision 401k Accident & Critical Illness Life Insurance PTO, Holiday Pay, and Floating Holidays Tuition Reimbursement

Company Profile: At Verastem Oncology, we're advancing innovation and addressing the urgent needs of patients living with cancers driven by RAS/MAPK pathway mutations, a key driver of tumor growth and treatment resistance. The FDA approval of AVMAPKI FAKZYNJA CO-PACK delivered the first therapy specifically for women living with recurrent KRAS-mutated low-grade serous ovarian cancer, a rare cancer with significant unmet need. We've successfully launched this innovative combination therapy in the U.S. and are exploring regulatory pathways for Europe and Japan. We are continuing to advance our pipeline of drugs that we believe will help block cancer cell survival, inhibit tumor growth, and overcome treatment resistance. With clinical trials underway, we have an exciting opportunity to shape the future of cancer care and make a meaningful impact in the lives of patients. The TMF Document Specialist is responsible for owning and overseeing the management and quality control of Trial Master File (TMF) documentation across multiple Phase I-IV global studies. This hands-on role involves leadership in document management processes, ensuring compliance with regulatory requirements, and providing expert guidance to project teams. The TMF Document Specialist will play a key role in inspection readiness, process improvement, and training initiatives. The TMF Document Specialist works closely with cross-functional teams, including Clinical Operations, Quality Assurance, Regulatory Affairs, and vendors/CROs to ensure the accuracy, completeness, and timeliness of TMF documentation. TMF Document Management & Oversight Strategically manage the document lifecycle in Veeva Vault eTMF, including creation, version control, review, approval, and archival, ensuring alignment with study timelines and regulatory requirements. Lead and perform milestone TMF reviews, ensuring that all required documents are accurately filed, complete, and accessible. Serve as a hands-on TMF expert, guiding staff and study team members on best practices in document management. Ensure that all TMF documentation meets regulatory standards and internal SOPs, proactively identifying and addressing potential compliance risks. Lead efforts to identify, communicate, and resolve document inconsistencies, discrepancies, and gaps. Work closely with functional areas and the TMF Manager to implement corrective actions and prevent future issues; support implementation of corrective actions, as needed. Identify eTMF trends and commonly misfiled documents. Lead the creation and delivery of targeted training sessions for the TMF Community including guiding key document attributes (i.e., classification of documents) and resolution of document queries. Oversee the proactive management of clinical documentation and trackers, ensuring that all documentation is up-to-date, compliant, and readily accessible. Supports TMF System Administrator with activities related to TMF Migrations, such as QA Testing or Data Enrichment. Project Team Support Act as a senior liaison between vendors/CROs, and study teams, providing expert guidance and support on TMF documentation requirements throughout the study lifecycle. Collaborate with internal stakeholders to gather and provide critical information needed for the execution of the Expected Document List (EDL) requirements and expected numbers, ensuring alignment with Study Specific TMF Plan and TMF Index. Serve as the Subject Matter Expert (SME) for TMF documents, providing consultation and guidance to study teams and TMF operations on complex document management issues, in both an insourced and outsourced model. Provide oversight of vendor/CRO TMF deliverables, including quality and adherence to contractual expectations. TMF Metrics & Reporting Lead the monitoring of TMF processing metrics, ensuring that documents are processed, reviewed, and submitted in a timely manner. Use data-driven insights to identify areas for improvement. Track and report on key performance indicators (KPIs) related to TMF quality, compliance, and processing efficiency. Provide strategic recommendations to improve TMF processes. Provide regular TMF/eTMF status updates during Clinical Project Team Meetings and Clinical Operations Team meetings. Inspection Readiness Ensure the TMF complies with all applicable regulatory requirements and guidelines. Prepare for and support regulatory inspections and audits related to the TMF, including preparation of documentation. Partner with Quality Assurance to build inspection readiness practices appropriate for a growing organization. Qualifications Bachelor's Degree Required. 3+ years of hands-on Veeva Vault eTMF experience required. 5+ years of experience working directly in TMF Operations within the clinical research or pharmaceutical industry. Experience in a start-up with global clinical trials is highly desirable. TMF Certification or TMF training optional but preferred (e.g., DIA's TMF Certificate Program. LMK TMF University) or other relevant certifications. Key Skills, Abilities, and Competencies Working knowledge of clinical research documents across Research and Development (i.e., Regulatory, Clinical Supplies, Drug Safety, Biostatistics, etc.). Experience in managing TMF documents during audits or regulatory inspections. Extensive experience in TMF management, with a deep understanding of GCP, GDP, ALCOA+ standards, and regulatory requirements. Basic understanding of study and site management and overall trial planning and execution. Basic understanding of ICH-GCP guidelines and FDA/MHRA/EMA/PMDA regulations. Familiarity with MS Word, MS Excel (strongly preferred), and MS PowerPoint. Core Competencies Ability to work independently and collaboratively, taking ownership as required, in a fast-paced, evolving matrixed team environment consisting of internal and external team members. Analytical thinker with excellent problem-solving skills with the ability to manage ambiguity and shifting priorities and deadlines. Strong work ethic, organizational skills, oral and written communication skills, a ‘can do' approach, problem-solving skills, and team player skills. Ability to multi-task and manage several projects in parallel while paying attention to detail. Strong critical thinking skills and ability to contribute creative yet practical solutions to problems. The base salary range provided reflects our current estimate of what we anticipate paying for this position. Your actual base salary will be based on several factors, including job-related skills, experience, internal equity, relevant education or training, location, and market dynamics. In addition, you will be eligible for an annual bonus, equity compensation, and a competitive benefits package.

Company Profile: At Verastem Oncology, we're advancing innovation and addressing the urgent needs of patients living with cancers driven by RAS/MAPK pathway mutations, a key driver of tumor growth and treatment resistance. The FDA approval of AVMAPKI FAKZYNJA CO-PACK delivered the first therapy specifically for women living with recurrent KRAS-mutated low-grade serous ovarian cancer, a rare cancer with significant unmet need. We've successfully launched this innovative combination therapy in the U.S. and are exploring regulatory pathways for Europe and Japan. We are continuing to advance our pipeline of drugs that we believe will help block cancer cell survival, inhibit tumor growth, and overcome treatment resistance. With clinical trials underway, we have an exciting opportunity to shape the future of cancer care and make a meaningful impact in the lives of patients. The TMF Document Specialist is responsible for owning and overseeing the management and quality control of Trial Master File (TMF) documentation across multiple Phase I-IV global studies. This hands-on role involves leadership in document management processes, ensuring compliance with regulatory requirements, and providing expert guidance to project teams. The TMF Document Specialist will play a key role in inspection readiness, process improvement, and training initiatives. The TMF Document Specialist works closely with cross-functional teams, including Clinical Operations, Quality Assurance, Regulatory Affairs, and vendors/CROs to ensure the accuracy, completeness, and timeliness of TMF documentation. TMF Document Management & Oversight * Strategically manage the document lifecycle in Veeva Vault eTMF, including creation, version control, review, approval, and archival, ensuring alignment with study timelines and regulatory requirements. * Lead and perform milestone TMF reviews, ensuring that all required documents are accurately filed, complete, and accessible. * Serve as a hands-on TMF expert, guiding staff and study team members on best practices in document management. * Ensure that all TMF documentation meets regulatory standards and internal SOPs, proactively identifying and addressing potential compliance risks. * Lead efforts to identify, communicate, and resolve document inconsistencies, discrepancies, and gaps. Work closely with functional areas and the TMF Manager to implement corrective actions and prevent future issues; support implementation of corrective actions, as needed. * Identify eTMF trends and commonly misfiled documents. Lead the creation and delivery of targeted training sessions for the TMF Community including guiding key document attributes (i.e., classification of documents) and resolution of document queries. * Oversee the proactive management of clinical documentation and trackers, ensuring that all documentation is up-to-date, compliant, and readily accessible. * Supports TMF System Administrator with activities related to TMF Migrations, such as QA Testing or Data Enrichment. Project Team Support * Act as a senior liaison between vendors/CROs, and study teams, providing expert guidance and support on TMF documentation requirements throughout the study lifecycle. * Collaborate with internal stakeholders to gather and provide critical information needed for the execution of the Expected Document List (EDL) requirements and expected numbers, ensuring alignment with Study Specific TMF Plan and TMF Index. * Serve as the Subject Matter Expert (SME) for TMF documents, providing consultation and guidance to study teams and TMF operations on complex document management issues, in both an insourced and outsourced model. * Provide oversight of vendor/CRO TMF deliverables, including quality and adherence to contractual expectations. TMF Metrics & Reporting * Lead the monitoring of TMF processing metrics, ensuring that documents are processed, reviewed, and submitted in a timely manner. Use data-driven insights to identify areas for improvement. * Track and report on key performance indicators (KPIs) related to TMF quality, compliance, and processing efficiency. Provide strategic recommendations to improve TMF processes. * Provide regular TMF/eTMF status updates during Clinical Project Team Meetings and Clinical Operations Team meetings. Inspection Readiness * Ensure the TMF complies with all applicable regulatory requirements and guidelines. * Prepare for and support regulatory inspections and audits related to the TMF, including preparation of documentation. * Partner with Quality Assurance to build inspection readiness practices appropriate for a growing organization. Qualifications * Bachelor's Degree Required. * 3+ years of hands-on Veeva Vault eTMF experience required. * 5+ years of experience working directly in TMF Operations within the clinical research or pharmaceutical industry. Experience in a start-up with global clinical trials is highly desirable. * TMF Certification or TMF training optional but preferred (e.g., DIA's TMF Certificate Program. LMK TMF University) or other relevant certifications. Key Skills, Abilities, and Competencies * Working knowledge of clinical research documents across Research and Development (i.e., Regulatory, Clinical Supplies, Drug Safety, Biostatistics, etc.). * Experience in managing TMF documents during audits or regulatory inspections. * Extensive experience in TMF management, with a deep understanding of GCP, GDP, ALCOA+ standards, and regulatory requirements. * Basic understanding of study and site management and overall trial planning and execution. * Basic understanding of ICH-GCP guidelines and FDA/MHRA/EMA/PMDA regulations. * Familiarity with MS Word, MS Excel (strongly preferred), and MS PowerPoint. Core Competencies * Ability to work independently and collaboratively, taking ownership as required, in a fast-paced, evolving matrixed team environment consisting of internal and external team members. * Analytical thinker with excellent problem-solving skills with the ability to manage ambiguity and shifting priorities and deadlines. * Strong work ethic, organizational skills, oral and written communication skills, a 'can do' approach, problem-solving skills, and team player skills. * Ability to multi-task and manage several projects in parallel while paying attention to detail. * Strong critical thinking skills and ability to contribute creative yet practical solutions to problems. The base salary range provided reflects our current estimate of what we anticipate paying for this position. Your actual base salary will be based on several factors, including job-related skills, experience, internal equity, relevant education or training, location, and market dynamics. In addition, you will be eligible for an annual bonus, equity compensation, and a competitive benefits package.

Why Us? At Par Health, we believe great healthcare is built on getting the essentials right. We're looking for passionate, talented individuals who share our commitment to improving lives. With 4,000+ team members worldwide, we lead with pride and purpose-prioritizing quality and safety while fostering a culture of continuous improvement, accountability, and teamwork. Elevating the Essentials isn't just our tagline, it's the higher standard we live by every day. Summary The Chemist I, under direct supervision, learns and performs QC laboratory chemical analyses of raw materials, in-process materials, stability & finished products, and testing to support process validation. May participate in investigations. Learns and stays current with regulatory guidances and compendia relevant to laboratories and pharmaceutical manufacturing. Job Description Scope of Authority - span of control (work unit, site, department, division, etc.), monetary value of budget/spend authority ( capital, operating, etc.), P&L responsibility, etc. Typically supports one Par business, at a single site Key Accountabilities - key outcomes/deliverables, the major responsibilities, and % of time Accountability Responsibilities % of Time Analysis & Testing Conducts routine laboratory analyses: finished product testing, stability testing, raw material testing, cleaning verification testing and manufacturing in-process testing. Typical activities may include buffer/solution preparation, standard preparation and operating analytical instruments: HPLC, UV-Vis, FT-IR, GC and dissolution tester, melting point apparatus, viscometer, Karl Fischer titrator, pH meter, analytical balance, etc. Uses laboratory software for analyses 65% Lab Equipment Provides general laboratory support such as routine instrument cleaning/preventative maintenance/calibration, sample receiving, chemical inventory, document filing and housekeeping Cleans lab working surfaces and disposes of any excess chemicals, solutions, solvents, etc. in the special waste containers for each class of waste chemicals Under close supervision, learns to troubleshoot basic instrument problems 20% Investigations With guidance, participates in OOS/OOT/NOE and other investigations Elevates questionable sample results, OOS, and aberrant results immediately to Supervisor May assist in drafting, editing, and reviewing SOPs and laboratory investigations 10% Training Maintains assigned training records current and in-compliance May assist in the training of less senior laboratory staff 5% Compliance Performs assigned work in a timely and safe manner conforming to regulatory, company and compendiaI requirements within pharmaceutical manufacturing setting Document accurately data generated in notebooks/worksheets/LIMS in compliance with SOPs Follows internal processes related to controlled substances continuous Safety Follows EH&S procedures to ensure a safe work environment Follows all applicable safety and standards guidelines, such as SOPs, cGMP, DEA regulations good documentation practice and/or MSDS continuous Total 100% Qualifications Education & Experience Minimal acceptable level of education, work experience and certifications required for the job Bachelor of Science Degree in chemistry, chemical engineering or related field with analytical chemistry coursework required. Some pharmaceutical laboratory experience preferred. Knowledge Proficiency in a body of information required for the job e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc. Proficiency with various laboratory techniques/instruments: HPLC, UV-Vis, FT-IR, GC and dissolution tester, melting point apparatus, viscometer, Karl Fischer titrator, pH meter, analytical balance, etc. Basic knowledge of wet chemistry techniques Knowledge of applicable safety and standards guidelines: SOP, cGMP, GLP, DEA regulations and/or MSDS Competency in Microsoft Office Suite Skills & Abilities Often referred to as “competencies”, leadership attributes, skills, abilities or behaviors that may be enterprise, functional or job specific e.g. coaching, negotiation, calibration, technical writing etc. Ability to display and analyze data in a logical manner Good verbal and written communication skills as well as good computer skills Attention to details and accurate record keeping Establish and maintain cooperative working relationships with others Solid organizational skills Ability to take initiative, set priorities and follow through on assignments Physical Requirements Physical & mental requirements e.g. lift 40 pounds, walk across plant/warehouse, business travel (% of time), driving as part of work responsibilities, etc. Extended periods of sitting, standing, walking, reaching, climbing/balancing, kneeling/crouching/crawling, looking at monitor for extended periods, moderate noise levels and potential business travel. Work is in an FDA and DEA-regulated pharma lab environment with risk of exposure to various chemicals Must occasionally lift and/or move up to 15-25 lbs. Ability to wear personal protective equipment, including respirators, gloves, etc. Specific visions abilities are required by this job include close vision and color vision Ability to occasionally tolerate significant differences in temperature and/or humidity for short periods Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required. EEO Statement: We comply with all applicable federal, state, and local laws prohibiting discrimination and harassment, and provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, disability, veteran status, or genetic information, or any other classification protected by federal, state or local law. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.