Quality assurance specialist jobs in Madison, WI - 131 jobs

Join our team at Scientific Protein Laboratories (SPL), a world leader in biosourced pharmaceuticals, located just outside of Madison, Wisconsin in Waunakee! SPL is an innovative biopharmaceutical leader with unique products and services supporting the pharmaceutical industry globally. For over 40 years, SPL specializes in the development and cGMP compliant manufacturing of Active Pharmaceutical Ingredients (APIs). SPL has an exciting opportunity to join the team as a Manager Validation QA. The QA Validation Manager will lead and oversee the development, execution, and maintenance of validation programs within a biologics drug substance manufacturing environment. This role requires comprehensive experience across multiple validation disciplines, including equipment, process, computer systems, and cleaning validation. The Validation Manager ensures all validation activities comply with cGMP regulations, internal SOPs, and regulatory expectations, providing technical leadership to ensure the consistent production of high-quality biologics products. Responsibilities include: Participate in establishing and maintaining company validation management principles, standards, and operational requirements (SOPs, templates, guidelines, etc.) to ensure alignment with current regulatory expectations. Assist in maintaining and updating the Master Validation Plan (MVP) to ensure comprehensive coverage and appropriate review cycles. Develop, implement, and maintain validation strategies and plans for equipment, processes, cleaning, and computerized systems. Lead and manage cross-functional validation projects, ensuring on-time completion and compliance with regulatory requirements. Review, approve, and maintain validation documentation including protocols, reports, change controls, and deviations. Perform quality assessments of deviations, CAPAs, and change controls identified during validation activities to ensure timely handling in accordance with quality and validation requirements. Collaborate with manufacturing, quality, engineering, and IT teams to ensure validation activities are integrated with operational requirements. Monitor regulatory changes and industry best practices to identify opportunities for improving validation management processes. Support regulatory inspections and audits by providing validation expertise and documentation. Drive continuous improvement initiatives for validation processes and methodologies. Ensure risk-based approaches are applied to validation programs, including qualification and requalification activities. Additional Responsibilities Support technology transfer and scale-up activities for new biologics products. Participate in internal and external audits as validation subject matter expert. Monitor industry trends, guidance documents, and regulatory updates to maintain compliance. Lead root cause investigations and corrective actions related to validation deviations. Manage validation-related budgets and resource allocation. Job Requirements and Qualifications: Education: Required: Bachelor's degree or above in Pharmacy, Pharmaceutical Engineering, Biology, Chemistry, or related fields, Preferred: Master's degree or above in Pharmacy, Pharmaceutical Engineering, Biology, Chemistry, or related fields Experience: Required: 5+ years, minimum 2 years in Management, Preferred : 10+ years, minimum 2 years in Management WHY JOIN SPL? Our employees are our success! We recruit motivated people, recognize their contributions, and support their development to reach their full potential. Perks include: competitive compensation; excellent benefits package - including Medical, Dental and Vision on Day 1; Life and AD&D Insurance, and Short and Long-term Disability; Health and Flexible Saving Account options; Employee Assistance Program, generous vacation; paid Holidays; 401k; advancement opportunities; team-oriented environment; community involvement; company events and more! SPL is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age, color, creed, disability, gender identity, national origin, protected veteran status, race, religion, sex, sexual orientation, and any other status protected by applicable local, state or federal law.

* 12-hour rotating shifts * Nights: 3 days on / 2 days off / 2 days on / 3 days off (4:00 PM - 4:00 AM) * Training Schedule: Monday-Friday, 8:00 AM - 4:30 PM for 6-8 weeks Job Description The Quality Assurance Specialist will spend the majority of their time on the production floor assisting the operations team. They will perform verifications, conduct general walk-throughs, and carry out onsite reviews and mini audits to ensure compliance with established procedures. The role involves problem-solving, such as initiating deviations, and includes reviewing documents like executed batch records, cleaning records, and log books. When necessary, they will issue batch records. Approximately 80-85% of the time will be spent on the production floor, with the remainder in the office. Gowning requirements vary by area, ranging from safety shoes to full gowning. Responsibilities * Assist the operations team with verifications and conduct general walk-throughs of the production area. * Perform onsite reviews and mini audits to ensure compliance with established procedures. * Initiate deviations and propose solutions to identified problems. * Review documents including executed batch records, cleaning records, and log books. * Issue batch records as required. Essential Skills * Quality assurance expertise. * Experience with FDA regulations. * Knowledge of batch records and CAPA processes. * Experience in conducting audits and document control. * Familiarity with pharmaceutical industry standards. Additional Skills & Qualifications * Bachelor's degree in any science discipline preferred. * 2+ years of experience in a regulated industry (GMP/FDA/ISO) for Specialist level. * 5+ years of experience in a regulated industry (GMP/FDA/ISO) for Sr level. * 7+ years of experience in a regulated industry (GMP/FDA/ISO) for Lead level, with potential to supervise or lead. * Associates with 10 years of experience may be considered. Work Environment The work environment predominantly involves being on the production floor, with some time in an office setting. Interaction with the EQMS system is required. Employees are eligible for schedule incentives and shift differentials based on their assigned shifts. Job Type & Location This is a Permanent position based out of Waunakee, WI. Pay and Benefits The pay range for this position is $62000.00 - $90000.00/yr. Medical, Dental and Vision on day 1 of employment. The company provides Basic Life insurance, Basic AD&D insurance along with Short-term disability on all full-time employees. Employees have the option to elect Voluntary Life, Voluntary AD&D along with Long-term disability coverage. Health and Flexible spending account options. Full-time employees can contribute to their 401k upon hire and are eligible for a company contribution. Annually, 160 hours of vacation & 40 hours of sick time (both pro-rated base on hire date) and 9 paid holidays. Workplace Type This is a fully onsite position in Waunakee,WI. Application Deadline This position is anticipated to close on Jan 30, 2026. About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.

Job Description Workforce Solutions partners with companies to find the perfect match between top talent and the right role. If you're seeking a new job in the Audit field within the public accounting industry, submit your resume today! Some job titles you may be seeking could include: Staff Auditor Assurance/Audit Associate Senior Auditor Senior Assurance/Audit Associate Assurance/Audit Senior Assurance/Audit Manager Senior Assurance/Audit Manager Assurance/Audit Director Assurance/Audit Partner Assurance/Audit Partner-in-Charge Peer Reviewer By joining our talent network, you'll gain access to job openings that match your skills, experience, and career goals. Whether you're looking for a full-time, part-time, remote, hybrid, or onsite position, our team of expert recruiters is dedicated to connecting you with roles that fit your needs. Ready to find your next opportunity? Submit your resume, and let us help you take the next step in your career journey!

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients. We are PCI. Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI. The QA Specialist will work with other departments to ensure the quality of products and compliance to internal procedures and external standards. Primary responsibilities for this role includes Batch Record Review, Lot Disposition, and Quality System review. This position may also be responsible for evaluating deviation incidences and determining which warrant escalation to an investigation, quality review and approval of investigations, and creating and monitoring the associated CAPAs. In this role, the opportunity exists to shape and transform GxP programs by providing QA expertise and guidance to the manufacture of both clinical and commercial products. Essential Duties and Responsibilities: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The essential duties and responsibilities include the following but other duties may be assigned. Perform review of batch documentation for release of internal and external clinical products/commercial products, while ensuring compliance with cGMPs, site SOPs, and regulatory requirements. Prioritize record review in support of business needs including maintaining batch status and communicate release needs throughout the organization Review and approve master batch records for the timely initiation of GxP manufacturing activities Responsible for quality oversight and administration of the deviation/investigation and CAPA programs Review and approve Manufacturing, Quality Control, and other investigations in support of batch release and GMP compliance Provide direction for complex investigations and CAPAs Ensure timely, accurate and complete execution and documentation of quality system events: deviations, NCMRs, GxP investigations and CAPAs Review, develop, and improve quality system procedures, specifications, and test methods Review and approve CAPAs to prevent recurrence of deviations Review and approve Change Control documentation Responsible for tracking investigations and change control for timely completion. Provide status reports, including relevant quality metrics and participates in the management review process Establish collaborative relationships with internal and external customers to ensure all quality and compliance matters and any issues that arise are addressed in an open and timely manner. Monitor, identify and propose quality process and system improvements. Lead improvement projectsand communicate status to management Serve as QA representative to cross functional project teams such as tech transfer, process validation, and process improvement Coordinate change control review meetings Monitor status of change controls and facilitate the approval process Perform risk assessments to comply with internal procedures and external guidelines Provide training on department specific procedures and systems Interface with clients to address any documentation and compliance concerns Initiate, revise, and review controlled cGMP documents including SOPs, Material Specifications, Investigation protocols/reports, validation protocols/reports as applicable Ensures site readiness for regulatory inspections Special Demands: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. The employee must be physically capable to perform the duties listed below with or without reasonable accommodations which may be made to enable individuals with disabilities to perform the essential functions. Frequent reading, writing, and verbal communication Must be able to travel between multiple local production facilities Able to translate ideas to actual concepts and processes Proven ability to manage multiple projects (duties) simultaneously Able to work in a highly complex environment with competing demands and priorities Work Environment: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Cross functional staff, members of management, internal and external clients, members of the Quality organization No managerial responsibilities. This is an individual contributor role. TRAVEL - < 10% Qualifications: The requirements listed below are representative of the knowledge, skill, and/or ability required for the stated position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Experience performing RCA, technical writing, and working with quality related investigations Knowledge of laboratory and production equipment and IQ/OQ/PQ Knowledge of FDA regulations (i.e., 21CFR Part 210, 211 & 820) and some experience working with international regulations such as ICH Experience using Risk Management Tools (FMEA, HACCP, PHA, etc.) and familiarity with ICH Q9 Bachelor's Degree in a relevant scientific discipline preferred with a minimum of 3-5 years of pharmaceutical or biotech industry experience with 2+ years of experience in a QA Operations role supporting late stage clinical and/or commercial production ASQ certification preferred Exceptional organizational skills and attention to detail Ability to make risk based decisions and resolve issues with minimal guidance Excellent interpersonal skills and the ability to communicate well orally and in writing Proficiency in MS Office including Word, Excel, Access and Visio Excellent verbal and written communication skills required Ability to work in a dynamic, fast paced work environment Honesty, integrity, respect and courtesy with all colleagues Creative with the ability to work with minimal supervision and balanced with independent thinking Resilient through operational and organizational change #LI-LL1 Join us and be part of building the bridge between life changing therapies and patients. Let's talk future Equal Employment Opportunity (EEO) Statement: PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status. At PCI, Equity and Inclusion are at the core of our company's purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.

I am Zach from Pioneer Data System, Inc. We have an immediate requirement for a Quality Assurance specialist (GMP / Pharma Industry) If you are interested please call me at **************** or respond to this email. Job Title: Quality Assurance specialist (GMP / Pharma Industry) Duration: 9+ Months Location: Middleton, Wisconsin. 53562 Job Description: Provides project support with current Good Manufacturing Practices to clinical supply packaging operations. Provides guidance on procedures and training necessary to be in complete compliance with current GMPs. Position Comments visible to MSP and Supplier: Perform wise variety of QA related tasks. QC inspection, Maintain training system Thank you. Additional Information All your information will be kept confidential according to EEO guidelines.

We're looking for a Remote Quality Assurance Coordinator to join our team! The Quality Assurance Coordinator is responsible to ensure reports are completed at the highest level of quality and integrity and in full compliance with client contractual agreement, regulatory agency standards and/or federal and state mandates. This position is required to handle quality assurance questions and provide overall support to the Quality Assurance Department. The schedule is Monday to Friday 10:00am to 6:30pm CT (with occasional weekend coverage). ESSENTIAL JOB FUNCTIONS Perform quality assurance review of reports, correspondences, addendums or supplemental reviews. Ensure clear, concise, evidence-based rationales have been provided in support of all recommendations and/or determinations. Ensure that all client instructions and specifications have been followed and that all questions have been addressed. Ensure each review is supported by clinical citations and references when applicable and verifies that all references cited are current and obtained from reputable medical journals and/or publications. Ensure the content, format, and professional appearance of the reports are of the highest quality and in compliance with company standards. Ensure that the appropriate board specialty has reviewed the case in compliance with client specifications and/or state mandates and is documented accurately on the case report. Verify that the peer reviewer has attested to only the facts and that no evidence of reviewer conflict of interest exists. Ensure the provider credentials and signature are adhered to the final report. Identify any inconsistencies within the report and contact the Provider to obtain clarification, modification or correction as needed. Assist in resolution of customer complaints and quality assurance issues as needed. Ensure all federal ERISA and/or state mandates are adhered to at all times. Provide insight and direction to management on consultant quality, availability and compliance with all company policies and procedures and client specifications. Promote effective and efficient utilization of company resources. Participate in various educational and or training activities as required. Perform other duties as assigned. Qualifications Education and/or Experience High school diploma or equivalent required. Two years IME or medical experience preferred. Knowledge of the insurance industry preferably claims management relative to one or more of the following categories: workers' compensation, no-fault, liability, and/or disability preferred. QUALIFICATIONS Must have strong knowledge of medical terminology, anatomy and physiology, medications and laboratory values. Must be able to add, subtract, multiply, and divide in all units of measure, using whole numbers and decimals; Ability to compute rates and percentages. Must be a qualified typist with a minimum of 40 W.P.M preferred. Must be able to operate a general computer, fax, copier, scanner, and telephone. Must be knowledgeable of multiple software programs, including but not limited to Microsoft Word, Outlook, Excel, and the Internet. Must possess excellent skills in English usage, grammar, punctuation and style. Ability to follow instructions and respond to upper managements' directions accurately. Must demonstrate accuracy and thoroughness. Look for ways to improve and promote quality and monitors own work to ensure quality is met. Must demonstrate exceptional communication skills by conveying necessary information accurately, listening effectively and asking questions where clarification is needed. Must be able to work independently, prioritize work activities and use time efficiently. Must be able to maintain confidentiality. Must be able to demonstrate and promote a positive team -oriented environment. Must be able to stay focused and concentrate under normal or heavy distractions. Must be able to work well under pressure and or stressful conditions and must possess the ability to manage change, delays, or unexpected events appropriately. Ability to follow all company policies and procedures in effect at time of hire and as they may change or be added from time to time. ExamWorks is a leading provider of innovative healthcare services including independent medical examinations, peer reviews, bill reviews, Medicare compliance, case management, record retrieval, document management and related services. Our clients include property and casualty insurance carriers, law firms, third-party claim administrators and government agencies that use independent services to confirm the veracity of claims by sick or injured individuals under automotive, disability, liability and workers' compensation insurance coverages. ExamWorks offers a fast-paced team atmosphere with competitive benefits, paid time off, and 401k. ExamWorks, LLC is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, pregnancy, genetic information, disability, status as a protected veteran, or any other protected category under applicable federal, state, and local laws. Equal Opportunity Employer - Minorities/Females/Disabled/Veterans

The Assurance Associate will be responsible for preparing financial statements with disclosures, applying basic areas of GAAP as necessary and documenting, validating, testing, and assessing various control systems. This position may also be involved in reviews and agreed-upon procedure engagements. The Assurance Associate will be expected to travel, as needed, to meet firm and client needs. Job Duties Control Environment: * Applies knowledge and understanding of the collective effect of various factors on establishing or enhancing effectiveness, or mitigating the risks, of specific policies and procedures by: * Identifying and considering all applicable policies, laws, rules, and regulations of the firm, regulators, or other authoritative bodies as part of engagement team; * Making constructive suggestions to improve client internal controls and accounting procedures; * Documenting and validating the operating effectiveness of the clients' internal control system. GAAP: * Applies knowledge and understanding of governing principles; applying these principles to client transactions; and documenting and communicating an understanding and application of these principles by: * Providing support of conclusions with authoritative literature; * Drafting basic sets of financial statements with disclosures; * Researching intermediate areas of accounting and forming an initial opinion on the correct treatment independently GAAS: * Applies knowledge and understanding of professional standards; application of the principles contained in professional standards; and the ability to document and communicate an understanding and application of professional standards on an engagement by: * Developing and applying an intermediate knowledge of auditing theory, a sense of audit skepticism, and the use of BDO audit manuals * Applying auditing theory to various client situations * Documenting in line with BDO policy, identifying deviations and notifying more senior team members in order to obtain appropriate approvals * Applying knowledge to identify instances where testing may be reduced or expanded and notifying more senior team members of the occurrence * Contributing ideas/opinions to the engagement teams Methodology: * Applies knowledge and application of BDO standards to guide effective and efficient delivery of quality services and products by: * Completing all appropriate documentation of BDO work papers * Ensuring assigned work is performed in accordance with BDO methodology and requirements Research: * Applies methodology used to seek or maintain information from authoritative sources and to draw conclusions regarding a target issue based on the information by: * Researching basic and intermediate accounting topics and forming an initial opinion on the treatment independently * Other duties as required Qualifications, Knowledge, Skills and Abilities: Education: * Bachelor's degree in Accounting, Finance, Economics or Statistics, required OR Bachelor's degree in other focus area and CPA certification, required * Master's in Accountancy, preferred Experience: * Leadership experience, preferred * Accounting based internship, preferred License/Certifications: * Eligible to sit for the CPA exams upon starting employment, required * Actively pursuing completion of CPA exams, preferred Software: * Proficient with the Microsoft Office Suite, required Other Preferred Knowledge, Skills & Abilities: * Strong written and verbal communication skills * Ability to follow instructions as directed * Ability to work effectively in a team setting * Ability and willingness to travel, as needed, required * Takes appropriate actions without being asked * Basic understanding and experience planning and coordinating the stages to perform an audit of a basic public and/or private company Individual salaries that are offered to a candidate are determined after consideration of numerous factors including but not limited to the candidate's qualifications, experience, skills, and geography. California Range: $85,000 - $90,000 Colorado Range: $73,000-$77,000 Illinois Range: $78,000-$82,000 Maryland Range: $83,000-$87,000 Massachusetts Range: $83,000-$87,000 Minnesota Range: $70,000-$74,000 New Jersey Range: $78,000-$82,000 NYC/Long Island/Westchester Range: $83,000-$87,000 Ohio Range: $71,000 - $75,000 Washington Range: $78,000 - $80,000 Washington DC Range: $83,000-$87,000

Job DescriptionDescription: Are you looking to start your career in food safety and make a meaningful impact right away? As our Quality Assurance Specialist, you'll step into a brand-new, entry-level role where you'll help shape our food safety culture, support compliance, and contribute directly to delivering safe, high-quality cheese products across the nation. We have openings for a Quality Assurance Specialist to join our team. The Food Safety Specialist oversees key aspects of the company's compliance with food safety regulations and certification standards while helping to foster a positive food safety culture. This role provides guidance, support, and oversight to ensure the organization consistently meets external requirements and internal expectations for safe, high-quality products. Freshpack is a custom cheese packaging company that develops and innovates cheese products and packaging. Our products can be found in all 50 states and in most major retailers. Over the past 25 years, our team has grown from 15 to 280+ employees. It is an exciting time to join our team, as we are poised for substantial growth over the next 3-5 years. Responsibilities Food Safety Culture Help drive positive food safety culture through organization Keep organization informed on food safety related topics Keep a pulse on the organization's current food safety culture Active role on food safety team Organize meetings Manage short-term and long-term projects Partake in external food safety trainings Compliance SQF Code for Food Manufacturing Assist in ensuring compliance with suppliers, service providers, and co-manufacturers Perform sanitary design reviews on new and existing equipment Ensure company preparedness of crisis Active role on food defense team Lead food fraud mitigation efforts Ensure compliance with other regulatory and customer requirements Keep customer portals current and updated Complete customer questionnaires Stay current and communicate changes to the organization Auditing SQF, Regulatory, and Customer audits (3rd party) Help ensure the organization is in compliance with all rules, regulations, and expectations Maintain all food safety certifications and regulatory licenses Organize mock food safety exercises and challenges Perform preventive control and prerequisite program validations Requirements: Required Skills/Abilities Written skills Attention to detail, observation, and organizational skills Planning and project management Education and Experience Bachelor's Degree preferred Certified in HACCP and Preventive Controls for Human Food Knowledgeable (1-3 years experience) in SQF and FDA regulations Physical Requirements Prolonged periods of sitting at a desk and working on a computer. KPI Frequency/Project Driven Goals KPI's are to be presented and approved before the beginning of the quarter and results to be presented following the end of the quarter. Benefits Medical, dental, vision, company-provided life insurance & more! Referral program 401(k) program Pay for Performance program Get paid every Friday!

Baker Tilly is a leading advisory, tax and assurance firm, providing clients with a genuine coast-to-coast and global advantage in major regions of the U.S. and in many of the world's leading financial centers - New York, London, San Francisco, Los Angeles, Chicago and Boston. Baker Tilly Advisory Group, LP and Baker Tilly US, LLP (Baker Tilly) provide professional services through an alternative practice structure in accordance with the AICPA Code of Professional Conduct and applicable laws, regulations and professional standards. Baker Tilly US, LLP is a licensed independent CPA firm that provides attest services to its clients. Baker Tilly Advisory Group, LP and its subsidiary entities provide tax and business advisory services to their clients. Baker Tilly Advisory Group, LP and its subsidiary entities are not licensed CPA firms. Baker Tilly Advisory Group, LP and Baker Tilly US, LLP, trading as Baker Tilly, are independent members of Baker Tilly International, a worldwide network of independent accounting and business advisory firms in 141 territories, with 43,000 professionals and a combined worldwide revenue of $5.2 billion. Visit bakertilly.com or join the conversation on LinkedIn, Facebook and Instagram. Please discuss the work location status with your Baker Tilly talent acquisition professional to understand the requirements for an opportunity you are exploring. Baker Tilly is an equal opportunity/affirmative action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability or protected veteran status, gender identity, sexual orientation, or any other legally protected basis, in accordance with applicable federal, state or local law. Any unsolicited resumes submitted through our website or to Baker Tilly Advisory Group, LP, employee e-mail accounts are considered property of Baker Tilly Advisory Group, LP, and are not subject to payment of agency fees. In order to be an authorized recruitment agency ("search firm") for Baker Tilly Advisory Group, LP, there must be a formal written agreement in place and the agency must be invited, by Baker Tilly's Talent Attraction team, to submit candidates for review via our applicant tracking system. Job Description: Are you looking for an accounting role to launch your career? Do you want to work with privately held and publicly traded companies that occupy all stages of development? As an Assurnace Associate at Baker Tilly (BT), you will be a value architect delivering audit and other assurance services to clients. As one of the fastest growing firms in the nation, BT offers you upward career trajectory, flexibility in how and where you get your work done and meaningful relationships with clients, teammates and leadership who truly care about you and your development. You will enjoy this role if you: * Desire to become a trusted business advisor, working face-to-face with clients to find creative solutions to complex accounting and business challenges * Want to work for a leading CPA advisory firm whose owners have both their clients' and employees' best interests in mind and are transparent in their decisions * Value your development and want to work for a firm that provides a great work environment (ask us about My Time Off, My Development and Dress for Your Day!) * Want to grow professionally and develop your client service and technical accounting skills to build a career with endless opportunities now, for tomorrow You will have the opportunity to: * Be a trusted member of the engagement team providing various assurance and consulting services: * Proactively engage with your clients throughout the year to gather needed information to complete testing and respond to questions raised * Perform substantive testing on client's balance sheets and income statements * Test for deficiencies of internal controls and discussing recommendations for improvement * Learn and grow from direct on-the-job coaching and mentoring along with participating in firm wide learning and development programs * Utilize your entrepreneurial skills to network and build strong relationships internally and externally with clients * Build friendships and strong work relationships while gaining valuable experience Qualifications Successful candidates will have: * Bachelor's or master's degree in accounting or a related degree in business, with sufficient course work and credits to sit for the CPA exam in the state you are being considered * Outstanding academic performance required, with a preferred GPA of 3.0 or above * Relevant internship, work experience and/or involvement with a professional organization * The ability to work effectively in a team environment with all levels of client personnel * Demonstrated skills in the areas of time management, communication, interpersonal skills, relationship building, collaboration, and problem solving * Organizational and analytical skills, initiative, adaptability * Proficiency with Microsoft programs (Word, Excel, PowerPoint, etc.) * There is currently no immigration sponsorship available for this position

About Company: Naturpak is the world's largest co-manufacturer that utilizes the Tetra Recart format for human and animal nutrition, chosen as a trusted partner by market-leading brands. Strategically based in America's Heartland near many of the largest food and vegetable sources in the country, NaturPak is your leading shelf-stable solutions partner dedicated to supporting consumer and pet brand companies with everything from R&D to packaging, and more. From concept to creation, NaturPak is your partner in creating deliciously original products. We're All In. About the Role: The Quality Assurance/Control Administrator plays a critical role in ensuring that products and services meet established standards of quality, reliability, and performance. This position is responsible for developing, implementing, and maintaining quality control processes and documentation to support compliance with regulatory requirements and internal policies. The role involves close collaboration with production, engineering, and supply chain teams to identify areas for improvement and to drive corrective actions when deviations occur. The administrator will analyze quality data, prepare detailed reports, and communicate findings to stakeholders to facilitate informed decision-making. Ultimately, this position ensures that the organization consistently delivers high-quality products that satisfy customer expectations and regulatory standards. Minimum Qualifications: Must be able to Read, Write and Speak English Excellent written and verbal communication skills. Preferred Qualifications: Certification in quality management such as ASQ Certified Quality Auditor (CQA) or Certified Quality Improvement Associate (CQIA). Experience with regulatory compliance standards relevant to the industry (e.g., FDA, ISO, GMP). Familiarity with Lean, Six Sigma, or other continuous improvement methodologies. Experience working in a manufacturing or production environment. Advanced skills in data analytics and quality management software. Responsibilities: Develop, implement, and maintain quality assurance and control procedures in accordance with industry standards and regulatory requirements. Conduct regular inspections and audits of production processes and finished products to ensure compliance with quality standards. Document and report quality issues, non-conformances, and corrective actions, maintaining accurate and up-to-date records. Collaborate with cross-functional teams to investigate quality problems and implement effective solutions to prevent recurrence. Analyze quality data and metrics to identify trends, risks, and opportunities for continuous improvement. Coordinate with suppliers and vendors to ensure incoming materials meet quality specifications. Support internal and external audits by preparing necessary documentation and facilitating audit activities. Skills: The Quality Assurance/Control Administrator utilizes analytical skills daily to interpret quality data and identify trends that impact product quality. Strong communication skills are essential for effectively documenting findings, reporting issues, and collaborating with cross-functional teams to implement corrective actions. Attention to detail is critical when conducting inspections, audits, and reviewing documentation to ensure compliance with standards. Problem-solving skills are applied to investigate quality deviations and develop sustainable solutions that enhance processes. Additionally, proficiency with quality management systems and software tools supports efficient data management, reporting, and continuous improvement initiatives. 1st

The purpose of this position is to provide medical device quality assurance support at Arrowhead. This position will report to the Director, Supply Chain Quality and works closely with members of Quality, Operations, Supply Chain, Regulatory, and Commercial teams, as well as external stakeholders and suppliers. This position will provide Medical Device Subject Matter Expertise to support Quality and project teams to ensure clinical and commercial product quality are in compliance with relevant US and ROW medical device regulations, guidance, and laws. Responsibilities * Serve as an internal medical device subject matter expert, both US and ROW, for all relevant elements of QMS and quality of combination product development and commercialization, assuring proper integration and support of device regulations, including, but not limited to Change Management, Risk Management, DHF/DMR Maintenance, Internal Audits, etc. * Monitor, guide, and ensure internal stakeholders' decision-making and actions are consistent with QSR, ISO 13485, ISO 14189, Good Distribution Practices (GDP), relevant international laws and guidance, and Arrowhead policies and procedures. * Develop, define, support, review, augment, and/or approve a variety of controlled documents to ensure adherence to Medical Device Regulations and requirements. * Identify gaps in existing processes, as well as need for new processes. Collaborate with cross-functional teams for solution development and implementation. * Provide quality guidance to internal stakeholders and project teams during all phases of design control, risk management, human factor engineering, process development, verification/validation testing, packaging, and distribution, as well as lifecycle management of design changes and documentation. * Support continuous improvement to the combination product QMS, monitoring and identifying areas for improvement. * Support development and management of Supplier Quality activities such as Quality Agreements, supplier audits, and assessment and performance evaluations (SCARs, Customer Notifications, etc.) * Support internal audits, certifications, and regulatory inspections at Arrowhead and its suppliers. * Review Clinical Study Plans that include device instructions. Requirements: * BS/BA in an applicable scientific field such as chemistry, biology, or biochemistry is preferred * Minimum of eight (8) years industry experience in Quality Assurance, in which at least five (5) of those years were in a leadership position with increasing levels of responsibility. * Medical Device experience required. Combination Product and Supplier Quality experience preferred. * Knowledge of GxP, focus on QMS, QSR, as well as ICH/FDA, EU MDR, ISO 13485 guidance documents and standards applicable to clinical and commercial products. Preferred: * Works independently, is organized, can multi-task and adjust priorities in a fast-paced, dynamic work environment. * Well-developed communication and interpersonal skills, with the ability to influence stakeholders at all levels. * Ability to consistently communicate with external parties in a professional manner. * Competent knowledge of and ability to use Microsoft Word, Excel, Adobe Acrobat, DocuSign, SharePoint and SmartSheet. * Ability for occasional business

Join our team at Scientific Protein Laboratories (SPL), a world leader in biosourced pharmaceuticals, located just outside of Madison, Wisconsin in Waunakee! SPL is an innovative biopharmaceutical leader with unique products and services supporting the pharmaceutical industry globally. For over 40 years, SPL specializes in the development and cGMP compliant manufacturing of Active Pharmaceutical Ingredients (APIs). SPL has an exciting opportunity to join the team as a Operations On-site QA Specialist This position is responsible for Under minimal supervision from senior team members, executes written procedures associated with on-site Quality Assurance responsibilities focusing on on-site inspection of manufacturing and testing operations. 3rd shift, 4pm-4am, (3 nights on/2nights off, 2 nights on/3 nights off) Responsibilities include: The Operations On-Site QA Specialist will be introduced to the on-site QA department and associated functions and responsibilities. The individual will have prior experience in a cGMP QA setting similar to the items outlined below. With guidance from management this role will be responsible for learning the process and steps required to perform all functions independently. It is the expectation that the Operations On-Site QA Specialist will quickly learn to independently provide QA support to the organization as outlined below. Conducts on the floor reviews of all manufacturing and testing operations. Performs verifications required to support manufacturing and testing documentation (including but not limited to batch records, cleaning records, logbooks, and test methods). Assists all departments in the identification and evaluation of facility events. Performs on the floor reviews of executed batch records. Assists in the organization and/or the establishment/maintenance of relevant procedures/documents. Assists in audits where necessary. Supports the document control team in issuing records as needed. Performs other duties as assigned Job Requirements and Qualifications: Position will be filled up to the Lead level and determined at discretion of the hiring manager. Specialist Education: Required: Bachelor's Degree or above in a Scientific discipline or 2+ years QA experience in a regulated industry, Preferred: Bachelor's Degree or above in a Scientific discipline with 5+ years QA experience in a regulated industry Experience: Required: 2+ years, Preferred: 5+ years Senior Education: Required: Bachelor's Degree or above in a Scientific discipline or 5+ years QA experience in a regulated industry, Preferred: Bachelor's Degree or above in a Scientific discipline with 7+ years QA experience in a regulated industry Experience: Required:5+ years, Preferred: 7+ years Lead Education: Required: Bachelor's Degree or above in a Scientific discipline or 7+ years QA experience in a regulated industry, Preferred: Bachelor's Degree or above in a Scientific discipline with 10+ years QA experience in a regulated industry Experience: Required: 7+ years, Preferred: 10+ years WHY JOIN SPL? Our employees are our success! We recruit motivated people, recognize their contributions, and support their development to reach their full potential. Perks include: competitive compensation; excellent benefits package - including Medical, Dental and Vision on Day 1; Life and AD&D Insurance, and Short and Long-term Disability; Health and Flexible Saving Account options; Employee Assistance Program, generous vacation; paid Holidays; 401k; advancement opportunities; team-oriented environment; community involvement; company events and more! SPL is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age, color, creed, disability, gender identity, national origin, protected veteran status, race, religion, sex, sexual orientation, and any other status protected by applicable local, state or federal law.

The Quality Assurance Specialist is responsible for ensuring proper documentation, reviewing batch records, inspecting and approving raw materials, writing deviations, conducting investigations, managing change controls, and implementing CAPAs. This individual will perform shipping release procedures and support the preparation of Annual Product Review documentation for all marketed products. This individual will provide administrative support to the QA department including generating DCRs, organizing files, compiling data, and coordinating training activities. Responsibilities * Ensure proper documentation and review batch records. * Inspect and approve raw materials. * Write deviations, conduct investigations, and manage change controls. * Implement Corrective and Preventive Actions (CAPAs). * Perform shipping release procedures. * Support preparation of Annual Product Review documentation. * Provide administrative support to the QA department. * Generate DCRs, organize files, and compile data. * Coordinate training activities. Essential Skills * Quality assurance expertise. * Experience with FDA regulations and GMP/ISO standards. * Proficiency in batch record review and document control. * Understanding of CAPA processes. * Ability to conduct audits. Additional Skills & Qualifications * Bachelor's degree in any science discipline preferred. * 2+ years of experience in a regulated industry (GMP/FDA/ISO) required. * May consider candidates with 10 years of experience and an Associate's degree. Work Environment This is an office-based role with interaction with the EQMS system. The position operates outside of production areas, offering either shared or independent office space. Work is conducted during regular Monday to Friday, first shift hours. Job Type & Location This is a Permanent position based out of Waunakee, WI. Pay and Benefits The pay range for this position is $62000.00 - $90000.00/yr. Medical, Dental and Vision on day 1 of employment. The company provides Basic Life insurance, Basic AD&D insurance along with Short-term disability on all full-time employees. Employees have the option to elect Voluntary Life, Voluntary AD&D along with Long-term disability coverage. We also have Health and Flexible spending account options. Full-time employees can contribute to their 401k upon hire and are eligible for a company contribution. Annually, SPL offers 160 hours of vacation & 40 hours of sick time (both pro-rated base on hire date) and 9 paid holidays. Workplace Type This is a fully onsite position in Waunakee,WI. Application Deadline This position is anticipated to close on Jan 23, 2026. About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.

The Assurance Associate will be responsible for preparing financial statements with disclosures, applying basic areas of GAAP as necessary and documenting, validating, testing, and assessing various control systems. This position may also be involved in reviews and agreed-upon procedure engagements. The Assurance Associate will be expected to travel, as needed, to meet firm and client needs. Job Duties Control Environment: Applies knowledge and understanding of the collective effect of various factors on establishing or enhancing effectiveness, or mitigating the risks, of specific policies and procedures by: Identifying and considering all applicable policies, laws, rules, and regulations of the firm, regulators, or other authoritative bodies as part of engagement team; Making constructive suggestions to improve client internal controls and accounting procedures; Documenting and validating the operating effectiveness of the clients' internal control system. GAAP: Applies knowledge and understanding of governing principles; applying these principles to client transactions; and documenting and communicating an understanding and application of these principles by: Providing support of conclusions with authoritative literature; Drafting basic sets of financial statements with disclosures; Researching intermediate areas of accounting and forming an initial opinion on the correct treatment independently GAAS: Applies knowledge and understanding of professional standards; application of the principles contained in professional standards; and the ability to document and communicate an understanding and application of professional standards on an engagement by: Developing and applying an intermediate knowledge of auditing theory, a sense of audit skepticism, and the use of BDO audit manuals Applying auditing theory to various client situations Documenting in line with BDO policy, identifying deviations and notifying more senior team members in order to obtain appropriate approvals Applying knowledge to identify instances where testing may be reduced or expanded and notifying more senior team members of the occurrence Contributing ideas/opinions to the engagement teams Methodology: Applies knowledge and application of BDO standards to guide effective and efficient delivery of quality services and products by: Completing all appropriate documentation of BDO work papers Ensuring assigned work is performed in accordance with BDO methodology and requirements Research: Applies methodology used to seek or maintain information from authoritative sources and to draw conclusions regarding a target issue based on the information by: Researching basic and intermediate accounting topics and forming an initial opinion on the treatment independently Other duties as required Qualifications, Knowledge, Skills and Abilities: Education: Bachelor's degree in Accounting, Finance, Economics or Statistics, required OR Bachelor's degree in other focus area and CPA certification, required Master's in Accountancy, preferred Experience: Leadership experience, preferred Accounting based internship, preferred License/Certifications: Eligible to sit for the CPA exams upon starting employment, required Actively pursuing completion of CPA exams, preferred Software: Proficient with the Microsoft Office Suite, required Other Preferred Knowledge, Skills & Abilities: Strong written and verbal communication skills Ability to follow instructions as directed Ability to work effectively in a team setting Ability and willingness to travel, as needed, required Takes appropriate actions without being asked Basic understanding and experience planning and coordinating the stages to perform an audit of a basic public and/or private company Individual salaries that are offered to a candidate are determined after consideration of numerous factors including but not limited to the candidate's qualifications, experience, skills, and geography. California Range: $85,000 - $90,000 Colorado Range: $73,000-$77,000 Illinois Range: $78,000-$82,000 Maryland Range: $83,000-$87,000 Massachusetts Range: $83,000-$87,000 Minnesota Range: $70,000-$74,000 New Jersey Range: $78,000-$82,000 NYC/Long Island/Westchester Range: $83,000-$87,000 Ohio Range: $71,000 - $75,000 Washington Range: $78,000 - $80,000 Washington DC Range: $83,000-$87,000

Full-time Description Are you looking to start your career in food safety and make a meaningful impact right away? As our Quality Assurance Specialist, you'll step into a brand-new, entry-level role where you'll help shape our food safety culture, support compliance, and contribute directly to delivering safe, high-quality cheese products across the nation. We have openings for a Quality Assurance Specialist to join our team. The Food Safety Specialist oversees key aspects of the company's compliance with food safety regulations and certification standards while helping to foster a positive food safety culture. This role provides guidance, support, and oversight to ensure the organization consistently meets external requirements and internal expectations for safe, high-quality products. Freshpack is a custom cheese packaging company that develops and innovates cheese products and packaging. Our products can be found in all 50 states and in most major retailers. Over the past 25 years, our team has grown from 15 to 280+ employees. It is an exciting time to join our team, as we are poised for substantial growth over the next 3-5 years. Responsibilities Food Safety Culture Help drive positive food safety culture through organization Keep organization informed on food safety related topics Keep a pulse on the organization's current food safety culture Active role on food safety team Organize meetings Manage short-term and long-term projects Partake in external food safety trainings Compliance SQF Code for Food Manufacturing Assist in ensuring compliance with suppliers, service providers, and co-manufacturers Perform sanitary design reviews on new and existing equipment Ensure company preparedness of crisis Active role on food defense team Lead food fraud mitigation efforts Ensure compliance with other regulatory and customer requirements Keep customer portals current and updated Complete customer questionnaires Stay current and communicate changes to the organization Auditing SQF, Regulatory, and Customer audits (3rd party) Help ensure the organization is in compliance with all rules, regulations, and expectations Maintain all food safety certifications and regulatory licenses Organize mock food safety exercises and challenges Perform preventive control and prerequisite program validations Requirements Required Skills/Abilities Written skills Attention to detail, observation, and organizational skills Planning and project management Education and Experience Bachelor's Degree preferred Certified in HACCP and Preventive Controls for Human Food Knowledgeable (1-3 years experience) in SQF and FDA regulations Physical Requirements Prolonged periods of sitting at a desk and working on a computer. KPI Frequency/Project Driven Goals KPI's are to be presented and approved before the beginning of the quarter and results to be presented following the end of the quarter. Benefits Medical, dental, vision, company-provided life insurance & more! Referral program 401(k) program Pay for Performance program Get paid every Friday! Salary Description $50,000 to $60,000 per year

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients. We are PCI. Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI. Step Into Quality. Start Your Career with Purpose. Are you eager to build your career in pharmaceutical manufacturing while making a meaningful impact on product quality and patient safety? Join us at PCI as a Quality Associate I - Operations, where you'll be on the front lines of GMP production-supporting real-time quality oversight, solving problems as they arise, and ensuring that every product meets the highest standards of safety, efficacy, and compliance. This is an ideal role for early-career professionals passionate about science, quality, and continuous improvement. You'll receive hands-on training, mentorship, and exposure to industry best practices while working in a fast-paced, collaborative environment. What You'll Do Provide real-time QA support on the production floor: observe critical operations, audit procedures, and monitor compliance during GMP manufacturing Perform in-process reviews of executed batch records and documentation for completeness and accuracy Participate in lot disposition and review of drug product and intermediates Act as a first responder to quality issues, documenting investigations and supporting immediate corrective actions Conduct Acceptable Quality Limit (AQL) visual inspections of drug product Support deviation documentation, root cause investigations (using tools like 5 Whys, Fishbone), and CAPA processes Collaborate across departments and represent QA during manufacturing activities and process improvements Contribute to SOP revisions, quality initiatives, and regulatory readiness What You Bring Bachelor's degree in a relevant scientific field (preferred) 0-2 years of experience in the pharmaceutical or biotech industry 1+ years of experience in QA Operations (preferred) Understanding of GMP regulations (21 CFR 210/211/820); exposure to ICH guidelines and risk tools (FMEA, HACCP, ICH Q9) a plus Strong organizational and technical writing skills, with attention to detail Familiarity with Microsoft Word, Excel, and Outlook Ability to manage multiple tasks and communicate effectively across teams Self-starter mindset with the ability to work independently and escalate issues appropriately Flexible and adaptable to fast-paced, evolving environments Preferred but Not Required ASQ certification Exposure to Lean/Operational Excellence methodologies Experience supporting commercial or late-stage clinical GMP operations #LI-LL1 Join us and be part of building the bridge between life changing therapies and patients. Let's talk future Equal Employment Opportunity (EEO) Statement: PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status. At PCI, Equity and Inclusion are at the core of our company's purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.

Job Description About Company: Naturpak is the world's largest co-manufacturer that utilizes the Tetra Recart format for human and animal nutrition, chosen as a trusted partner by market-leading brands. Strategically based in America's Heartland near many of the largest food and vegetable sources in the country, NaturPak is your leading shelf-stable solutions partner dedicated to supporting consumer and pet brand companies with everything from R&D to packaging, and more. From concept to creation, NaturPak is your partner in creating deliciously original products. We're All In. About the Role: The Quality Assurance/Control Administrator plays a critical role in ensuring that products and services meet established standards of quality, reliability, and performance. This position is responsible for developing, implementing, and maintaining quality control processes and documentation to support compliance with regulatory requirements and internal policies. The role involves close collaboration with production, engineering, and supply chain teams to identify areas for improvement and to drive corrective actions when deviations occur. The administrator will analyze quality data, prepare detailed reports, and communicate findings to stakeholders to facilitate informed decision-making. Ultimately, this position ensures that the organization consistently delivers high-quality products that satisfy customer expectations and regulatory standards. Minimum Qualifications: Must be able to Read, Write and Speak English Excellent written and verbal communication skills. Preferred Qualifications: Certification in quality management such as ASQ Certified Quality Auditor (CQA) or Certified Quality Improvement Associate (CQIA). Experience with regulatory compliance standards relevant to the industry (e.g., FDA, ISO, GMP). Familiarity with Lean, Six Sigma, or other continuous improvement methodologies. Experience working in a manufacturing or production environment. Advanced skills in data analytics and quality management software. Responsibilities: Develop, implement, and maintain quality assurance and control procedures in accordance with industry standards and regulatory requirements. Conduct regular inspections and audits of production processes and finished products to ensure compliance with quality standards. Document and report quality issues, non-conformances, and corrective actions, maintaining accurate and up-to-date records. Collaborate with cross-functional teams to investigate quality problems and implement effective solutions to prevent recurrence. Analyze quality data and metrics to identify trends, risks, and opportunities for continuous improvement. Coordinate with suppliers and vendors to ensure incoming materials meet quality specifications. Support internal and external audits by preparing necessary documentation and facilitating audit activities. Skills: The Quality Assurance/Control Administrator utilizes analytical skills daily to interpret quality data and identify trends that impact product quality. Strong communication skills are essential for effectively documenting findings, reporting issues, and collaborating with cross-functional teams to implement corrective actions. Attention to detail is critical when conducting inspections, audits, and reviewing documentation to ensure compliance with standards. Problem-solving skills are applied to investigate quality deviations and develop sustainable solutions that enhance processes. Additionally, proficiency with quality management systems and software tools supports efficient data management, reporting, and continuous improvement initiatives. 1st

Join our team at Scientific Protein Laboratories (SPL), a world leader in biosourced pharmaceuticals, located just outside of Madison, Wisconsin in Waunakee! SPL is an innovative biopharmaceutical leader with unique products and services supporting the pharmaceutical industry globally. For over 40 years, SPL specializes in the development and cGMP compliant manufacturing of Active Pharmaceutical Ingredients (APIs). SPL has an exciting opportunity to join the team as an On-Site QA Specialist. Under minimal supervision from senior team members, this position is responsible to execute written procedures associated with on-site Quality Assurance responsibilities including but not limited to on-site inspection, batch record review and raw material inspection/release. Responsibilities include: • The On-Site QA Specialist will be introduced to the on-site QA department and associated functions and responsibilities. The individual will have prior experience in a cGMP setting similar to the items outlined below. With guidance from management this role will be responsible for learning the process and steps required to perform all functions independently. It is the expectation that the On-Site QA Specialist will quickly learn to independently provide QA support to the organization as outlined below. • Assists all departments in the identification and evaluation of facility events. Assures proper documentation is initiated to capture the event. • Reviews executed batch records. • Perform inspection and disposition of raw materials on the basis of approved specifications. • Writes deviations, investigations, change controls and/or CAPAs. • Performs shipping release procedures. • Assists in the preparation of Annual Product Review documentation for all SPL Marketed Products. • Administrative support for the on-site QA department such as generation of DCR's, file organization, data compilation, training activities, etc. Job Requirements and Qualifications: Position will be filled up to the mid-level and determined at discretion of the hiring manager. Education: Bachelor's degree or above required; Bachelor's degree or above in Scientific discipline preferred Experience: 2 plus years of experience required; 5 plus years of experience preferred WHY JOIN SPL? Our employees are our success! We recruit motivated people, recognize their contributions, and support their development to reach their full potential. Perks include: competitive compensation; excellent benefits package - including Medical, Dental and Vision on Day 1; Life and AD&D Insurance, and Short and Long-term Disability; Health and Flexible Saving Account options; Employee Assistance Program, generous vacation; paid Holidays; 401k; advancement opportunities; team-oriented environment; community involvement; company events and more! SPL is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age, color, creed, disability, gender identity, national origin, protected veteran status, race, religion, sex, sexual orientation, and any other status protected by applicable local, state or federal law.

Arrowhead Pharmaceuticals, Inc. (Nasdaq: ARWR) is a clinical stage biopharmaceutical company that develops medicines that treat intractable diseases by silencing the genes that cause them. Using a broad portfolio of RNA chemistries and efficient modes of delivery, Arrowhead therapies trigger the RNA interference mechanism to induce rapid, deep, and durable knockdown of target genes. RNA interference, or RNAi, is a mechanism present in living cells that inhibits the expression of a specific gene, thereby affecting the production of a specific protein. Arrowhead's RNAi-based therapeutics leverage this natural pathway of gene silencing. Arrowhead is focused on developing innovative drugs for diseases with a genetic basis, typically characterized by the overproduction of one or more proteins that are involved with disease. The depth and versatility of our RNAi technologies enables us to potentially address conditions in virtually any therapeutic area and pursue disease targets that are not otherwise addressable by small molecules and biologics. Arrowhead is leading the field in bringing the promise of RNAi to address diseases outside of the liver, and our clinical pipeline includes disease targets in the liver and lung with a promising pipeline of preclinical candidates. Arrowhead's corporate headquarters is in Pasadena, CA with research and development teams in Madison, WI & San Diego, CA, and a state of the art manufacturing facility in Verona, WI. Our employees are nimble, science-driven innovators who are collaborating to bring new therapies to patients in need. The Position The purpose of this position is to provide medical device quality assurance support at Arrowhead. This position will report to the Director, Supply Chain Quality and works closely with members of Quality, Operations, Supply Chain, Regulatory, and Commercial teams, as well as external stakeholders and suppliers. This position will provide Medical Device Subject Matter Expertise to support Quality and project teams to ensure clinical and commercial product quality are in compliance with relevant US and ROW medical device regulations, guidance, and laws. Responsibilities Serve as an internal medical device subject matter expert, both US and ROW, for all relevant elements of QMS and quality of combination product development and commercialization, assuring proper integration and support of device regulations, including, but not limited to Change Management, Risk Management, DHF/DMR Maintenance, Internal Audits, etc. Monitor, guide, and ensure internal stakeholders' decision-making and actions are consistent with QSR, ISO 13485, ISO 14189, Good Distribution Practices (GDP), relevant international laws and guidance, and Arrowhead policies and procedures. Develop, define, support, review, augment, and/or approve a variety of controlled documents to ensure adherence to Medical Device Regulations and requirements. Identify gaps in existing processes, as well as need for new processes. Collaborate with cross-functional teams for solution development and implementation. Provide quality guidance to internal stakeholders and project teams during all phases of design control, risk management, human factor engineering, process development, verification/validation testing, packaging, and distribution, as well as lifecycle management of design changes and documentation. Support continuous improvement to the combination product QMS, monitoring and identifying areas for improvement. Support development and management of Supplier Quality activities such as Quality Agreements, supplier audits, and assessment and performance evaluations (SCARs, Customer Notifications, etc.) Support internal audits, certifications, and regulatory inspections at Arrowhead and its suppliers. Review Clinical Study Plans that include device instructions. Requirements: BS/BA in an applicable scientific field such as chemistry, biology, or biochemistry is preferred Minimum of eight (8) years industry experience in Quality Assurance, in which at least five (5) of those years were in a leadership position with increasing levels of responsibility. Medical Device experience required. Combination Product and Supplier Quality experience preferred. Knowledge of GxP, focus on QMS, QSR, as well as ICH/FDA, EU MDR, ISO 13485 guidance documents and standards applicable to clinical and commercial products. Preferred: Works independently, is organized, can multi-task and adjust priorities in a fast-paced, dynamic work environment. Well-developed communication and interpersonal skills, with the ability to influence stakeholders at all levels. Ability to consistently communicate with external parties in a professional manner. Competent knowledge of and ability to use Microsoft Word, Excel, Adobe Acrobat, DocuSign, SharePoint and SmartSheet. Ability for occasional business Wisconsin pay range $130,000-$150,000 USD Arrowhead provides competitive salaries and an excellent benefit package. All applicants must have authorization to work in the US for a company. California Applicant Privacy Policy