CAPA jobs near me - 156 jobs

Job DescriptionWho We Are Alene Candles LLC & Midwest is a private label, contract manufacturer that produces high-quality candles for some of the world's most recognized retail, boutique, and cosmetic brands. With our headquarters in New Hampshire and locations in Ohio, we've been in business for over 30 years. We are passionate about making the best products in the world, making safety our number one priority, and being an insanely great place to work. The Position We are seeking a Quality Assurance Supervisor leads quality staff in the daily quality operations of the facility. You will develop and maintain standards, database information, reporting and verification, defect identification, defect trending, and leads efforts to identify root cause and corrective actions for internal quality escapes. You will also ensure the successful execution of directing resources to significantly improve product quality, departmental performance, and reducing costs. You will assist the Quality Assurance Manager in the daily operations of the Quality Assurance Department which includes leading the inspectors, technicians, and leads who perform the inspections of incoming materials, product in-processing and finished goods. You will also assist in communicating effectively with the business partners of the organization to continue to build positive relationships. NOTE: This is a first shift role, but all three shifts report to this position. You will be expected to occasionally work these off shifts to accurately assess the capabilities of the team that reports to them and provide support when needed. The Location We are located at 8860 Smith's Mill Rd, Ste 100, New Albany, OH 43054. This is an onsite position. Additional Job Details Supervise designated members of the Quality inspection staff in accordance to the responsibilities listed below. Ensure the compliance of Alene produced product to customer specification. Perform and oversee in-process and finished goods inspection and maintain the quality level of the inspections. Provide guidance on quality assurance processes and specifications to all departments as required. Actively participate in data collection and trend reporting. Ensure compliance with Alene workmanship, housekeeping and safety policies and procedures. Lead and participate in lean and 5S initiatives. Participate in the review of Quality department procedures to ensure their accuracy. Perform other tasks and duties as assigned by the Quality Assurance Manager. Monitor the collection of samples and BMEs and ensure their timely shipment to the designated recipients. Monitor and control quality holds. Actively report the finished goods hold status at daily production meetings. Back up for Quality Manager. Lead CAPA review process. Actively participate in the planning and execution of internal audits. Perform basic statistical analysis and be able to interpret and communicate results. Attend daily production meetings, MAP reviews, QFD and other meetings as required to ensure proper input and given by the Quality department and track record assigned action. Lead and/or participate in CAPA activities and formal responses as required. Required Qualifications Associate's Degree 5+ years of related experience Minimum 1 year of supervisory experience Preferred Qualifications Computer proficiency in spreadsheet and word processing software in a Windows environment. Strong basic skills including the ability to add, subtract, multiply and divide in all units of measure, using whole numbers, common fractions, and decimals. Ability to calculate figures and amounts such as rate, ratio, proportions, percentages, area, circumference, and volume. Ability to interpret graphs and charts. Be able to perform basic Statistical analysis, interpret, communicate and teach. ERP experience a plus Strong written and verbal communication skills. Excellent team building and communications skills Ability to work accurately, with interruptions, to meet deadlines. Knowledgeable in statistical process control. Knowledgeable in the concepts of LEAN Manufacturing and 5S Excellent problem solving skills. Ability to do analysis, draw conclusions, makes recommendations. Previous process industries experience a plus such as food or cosmetics. Benefits Alene offers a host of competitive benefits for full-time employees, some of which include: Medical, Dental, and Vision with a Healthcare Reimbursement Account, 401(k) with company match, Basic Life Insurance (100% company paid), Employee Assistance Program, Flexible Spending Account, Paid Holidays, Paid Time Off, Tuition Reimbursement and “Alene Gives Back” - our paid volunteer program. Alene Candles provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. Should you require assistance completing this application or during any phase of the interview process, please contact ********************* or call ************ and ask to speak to Human Resources. We will make every effort to accommodate your needs in a reasonable amount of time.

About Us We are a leading regenerative medicine company in the advanced and acute wound care space and are always looking for exceptional talent. Join a company where you will have an opportunity to grow professionally and personally and give strength to others by Empowering Healing. Our advanced wound care products are specially developed for the successful treatment of chronic and acute wounds. Our comprehensive portfolio of skin substitutes and other regenerative medicine products empower our patients with life-changing solutions. Our strength is giving others strength. What You Will Achieve: Answer incoming calls and emails from the Customer Service queue and to provide the highest level of customer service satisfaction possible for internal and external customers. The Customer Service Representative reports to the Supervisor, Customer Service West and works Monday-Friday from 11:30amEST8:30amPST - 8pmEST/5pmPST. This position can be a remote position. How You Will Achieve It: * Review and process phone, fax, and e-mailed orders into the order entry system to ensure that shipments are expedited timely and accurately. * Develop strong relationships with customers and Sales Representatives. * Provide customers with timely communications about products and the status of their orders. * Responsible for adherence to all SOP's, protocols, policies, regulatory requirements, and GMP's. * Investigate problems related to shipment of product, credits, and customer inquiries. * Effectively interface with hospitals, wound care centers and physicians to ensure the highest level of customer service is attained. * Keep up to date with product or service knowledge to effectively assist customers with their needs. * Handle customer accounts, process payments, and assist with billing or other account-related issues. * Maintain detailed records of customer interactions, including inquiries, complaints, and resolutions. * Collaborate with other departments within the company, such as sales or marketing, to provide seamless customer experiences. * Manage customer expectations and ensure that customers are satisfied with the level of service provided. * Continuously improve customer service skills through training and feedback. * Dept. Emails: Customers, TRS, PEPs, etc. * Assist in training new CSRs accurately/effectively. * Flexibility in daily work schedule to meet the changing needs of the business. * Understand steps needed to resolve problems as they relate to day-to-day processes. * Support International sales force with ease and process international orders. * Compliance Reporting: CAPA/Recall tracking as directed. * Track order shipments. * Distribute work from central email box to individual work folders * Process Technical Complaints as they come into the department and proceed as directed. * Ability to investigate problems related to shipment of product, credits, and customer inquiries. * Involvement in projects as directed by management while preforming the normal daily tasks. * Other duties as assigned. Job Requirements What You Need to Achieve It: * 3+ years Customer Service or relevant experience required * Associates or Bachelor's degree preferred * Experience working in a manufacturing environment, especially in the medical device, biotech or healthcare industries preferred * Familiar with the sales order cycle * Knowledge of the shipping process and experience dealing with UPS and FedEx. * PC / Software proficiency. * Familiarity with MS Office and MS Excel is required. * Microsoft Dynamics AX knowledge a plus * Outstanding call handling skills * Excellent verbal and written communication skills * Able to collaborate effectively with other departments * Patient, empathetic * Attention to detail and follow through * Exceptional organizational and multi-tasking competence with the ability to perform effectively and accurately under stress * Superior problem resolution skills * The ability to work in a fast-pasted environment * Must be a flexible team member that works effectively with management, fellow team members and personnel of all departments * Must provide superior, high quality customer service to both internal and external customers * Must be motivated by a desire to improve both self and departmental functioning and quality through ongoing growth, development, and a commitment to excellence What can we offer you? * 401k -- generous employer match with immediate vesting and financial planning resources * Comprehensive Medical, Dental and Vision coverage options effective on day one of employment * Flexible Spending Account (medical expenses or dependent care expenses) or Health Savings Account * Company paid insurances including Short Term, Long Term and Life insurances as well as voluntary options * Paid maternity leave and parental leave for all new parents * Adoption benefits * Education Assistance Policy - $5,000 per year for all employees * Wellness Program including free trainings on mental health, mindfulness, stress reduction, on-site flu shots and more * Employee Assistance Program * Generous paid time off including vacation, floating holidays, sick days, and company holidays * Free parking including an electric charging station (Canton and La Jolla) * Discounts at BJs Wholesale, Dell, Sullivan Tire, and Sprint The anticipated annualized base salary for this role is $50,000 - $57,500 and reflects current market data for similarly-sized life science companies and internal equity. Organogenesis is a multi-state employer, and this salary range may not reflect positions that work in other states. Base salary is part of our total rewards package which also includes the opportunity for merit-based increases, eligibility for our 401(k) plan with competitive company match, medical, dental, vision, education assistance, life and disability insurances and leaves provided in line with your work state and federal law. Our time-off policy includes paid vacation days, paid company holidays, and paid sick time. Total compensation, including base salary to be offered, will depend on elements unique to each candidate, including candidate experience, skills, education, and other factors permitted by law. We are an equal opportunity/affirmative action employer. All qualified applicants will receive consideration for employment without regard to age, sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, genetic information or any other characteristic protected by law. We do not accept unsolicited agency resumes and we are not responsible for any fees related to unsolicited resumes. Physical Required No Job Type Full-time Location Organogenesis Inc. West Coast (La Jolla, CA) - La Jolla, CA 92121 US (Primary) Education Associate Degree Career Level Individual Contributor Travel

YOUR PASSION, ACTIONS & FOCUS is our Strength Become one of our Contributors Join the KnipperHEALTH Team! Vice President of Operational Excellence The Vice President of Operational Excellence will lead strategic and tactical initiatives focused on improving operational efficiency, quality of customer service, and mistake-proofing across all facets of the organization's Marketing and Samples Management (MSM) and Third-Party Logistics (3PL) and warehousing services. This role is pivotal in transforming operational processes-including pick/pack, kitting, shipping/receiving, and warehouse execution-to deliver scalable, compliant, and cost-effective solutions for clients in the medical and pharmaceutical industry. Responsibilities Operational Strategy & Execution Develop and execute a comprehensive operational excellence roadmap across all warehouse operations in collaboration with site leadership and aligned with business goals, quality requirements, and client expectations. Lead continuous improvement programs in pick/pack, shipping, receiving, warehouse layout, and inventory movement. Champion lean methodologies, Six Sigma, and mistake-proofing (poka-yoke) practices to reduce variation and error in core processes. Own the standardization of operational workflows and drive process harmonization across sites and teams. Quality & Compliance Embed quality assurance principles directly into operational workflows and Standard Operating Procedures (SOPs). Partner with QA and Compliance to align warehouse and logistics processes with FDA, DEA, DSCSA, and GMP regulations. Lead root cause analysis and corrective/preventive action programs (CAPA) improvement plans for warehouse and distribution operations based on data information collected through Quality Management System. Implement and refine metrics and dashboards for performance tracking and compliance adherence. Leadership & People Management Lead and mentor a cross-functional team including warehouse supervisors, logistics managers, and quality leads. Drive a culture of accountability, safety, and continuous improvement through effective leadership and communication. Identify talent gaps and champion leadership development within operational teams. Ensure team alignment with organizational KPIs and customer service standards. Cross-Functional Collaboration Collaborate with Warehouse Operations, IT, Quality Assurance, Compliance, HR, and Client Services to optimize end-to-end process flow. Participates in regulatory inspections and audits as Compliance invites/requests. Serve as a key liaison to clients, ensuring operational transparency, issue resolution, and contract adherence. Guide automation initiatives and WMS enhancements to improve process visibility and scalability. The above duties are meant to be representative of the position and not all-inclusive. Qualifications Operational Strategy & Execution Develop and execute a comprehensive operational excellence roadmap across all warehouse operations in collaboration with site leadership and aligned with business goals, quality requirements, and client expectations. Lead continuous improvement programs in pick/pack, shipping, receiving, warehouse layout, and inventory movement. Champion lean methodologies, Six Sigma, and mistake-proofing (poka-yoke) practices to reduce variation and error in core processes. Own the standardization of operational workflows and drive process harmonization across sites and teams. Quality & Compliance Embed quality assurance principles directly into operational workflows and Standard Operating Procedures (SOPs). Partner with QA and Compliance to align warehouse and logistics processes with FDA, DEA, DSCSA, and GMP regulations. Lead root cause analysis and corrective/preventive action programs (CAPA) improvement plans for warehouse and distribution operations based on data information collected through Quality Management System. Implement and refine metrics and dashboards for performance tracking and compliance adherence. Leadership & People Management Lead and mentor a cross-functional team including warehouse supervisors, logistics managers, and quality leads. Drive a culture of accountability, safety, and continuous improvement through effective leadership and communication. Identify talent gaps and champion leadership development within operational teams. Ensure team alignment with organizational KPIs and customer service standards. Cross-Functional Collaboration Collaborate with Warehouse Operations, IT, Quality Assurance, Compliance, HR, and Client Services to optimize end-to-end process flow. Participates in regulatory inspections and audits as Compliance invites/requests. Serve as a key liaison to clients, ensuring operational transparency, issue resolution, and contract adherence. Guide automation initiatives and WMS enhancements to improve process visibility and scalability. Knowledge, Skills & Abilities: Exceptional communication and change management skills. Ability to lead cross-functional teams through complex transformation initiatives. Data-driven mindset with a passion for operational analytics and structured problem solving. Customer-focused with a strong track record of operational delivery in client-centric environments. Agile, decisive, and calm under pressure. PHYSICAL DEMANDS: Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Knipper is an equal opportunity employer

At STERIS, we help our Customers create a healthier and safer world by providing innovative healthcare and life science product and service solutions around the globe. The Quality Analytics Analyst is responsible for assisting in administration of the quality analytics function to support the STERIS AST Quality and Operations analysis function globally. This position assists with the development and implementation of quality and operational analysis and reporting in various systems to support management review and decision-making. This position is active in supporting performance improvement initiatives and provides inputs for analysis that is presented to senior management and local site management across all AST facilities. The individual is responsible for completing assigned reporting and analytic requirements provided by internal and external Customers. The role is responsible for the reporting and analysis that supports the quality system to be compliant with, as appropriate, the following standards: ISO 9001, ISO 13485, FDA 21 CFR Part 820/211, EU GMPs, ISO 17025, ISO 11137 and/or ISO 11135 and other applicable regulatory standards. This role supports local site efforts focused on quality system improvement, supplier quality, process quality, new service/modality/technology development quality and quality system compliance. The Analyst, Quality Analytics supports and provides input to the preparation of the senior management review function and reporting to allow sites to meet all applicable regulatory standards. This role supports complaint/CAPA investigations, supplier quality improvement initiatives, continuous improvement initiatives and countermeasures with the use of statistical techniques and other accepted quality principles. This role also supports production and quality operations by coordinating and performing problem-solving investigations as assigned and reviews and analysisof quality system functions such as non-conformances, damages, calibration, dosimetry results, etc. This is a hybrid position. The schedule is Monday- Friday, 8 AM - 5 PM, with a requirement of working on-site on Mondays, Tuesdays, and Thursdays. What You'll Do as a Quality Analytics Analyst Coordinate individual day-to-day tasks to complete recurring (Monthly/Quarterly/Annually) reporting requirements for Quality Analytics function. Responsible for executing data refreshes and reporting updates at regular intervals to maintain accurate reporting for quality operations. Responsible for providing reporting and analytics for non-conformance trending across all Initiate and/or participate in corrective actions, problem-solving and continuous improvement activities. Travel to AST facilities, domestically and/or globally, to support remediation activities, audits/inspections and/or continuous improvement initiatives. Perform internal reviews of data trends among multiple systems, create reporting to illustrate data trending issues, and develop and execute actions to remediate any negative data trends as assigned by the Manager, Quality Analytics. Create or amend process documentation for reporting within the Quality Analytics function and provide input to Quality Operations work instructions where applicable. Review collected data to perform statistical analysis and recommend process changes to improve quality. Monitor and report on performance metrics. Instruct other STERIS employees in quality principles, effective corrective actions, and valid statistical techniques. Collaborate with other departments and facilities within the company on quality related issues. Support development of reports to enhance the STERIS quality system programs (i.e. calibration, maintenance, training, CAPA, complaints, non-conformances, supplier quality, management review, operational qualifications, document control, change control, risk management, etc). Overall responsibilities include commitment to ensure the accuracy of reporting data and analytics to meet external and internal requirements according to documented policies, procedures, standards and regulations. Perform other duties as assigned. Education Degree Bachelor's DegreeThe Experience, Abilities, and Skills Needed 1-5 years of combined statistical analysis and/or data management and analytics experience. 1-5 years of experience with medical device or other regulated industries preferred. 1-5 years of experience working in an ISO certified environment required. Working knowledge of FDA QSR/ EUGMP regulations strongly preferred. Advanced knowledge of data analytics tools such as SQL, Tableau, Minitab, etc. is preferred. This role requires on-site work in Mentor, Ohio on Mondays, Tuesdays, and Thursdays, with remote work available on Wednesdays and Fridays. Pay range for this opportunity is $72,000 - $90,000. Minimum pay rates offered will comply with county/city minimums, if higher than range listed. Pay rates are based on a number of factors, including but not limited to local labor market costs, years of relevant experience, education, professional certifications, foreign language fluency, etc. STERIS offers a comprehensive and competitive benefits portfolio. Click here for a complete list of benefits: STERIS Benefits Open until position is filled. STERIS is an Equal Opportunity Employer. We are committed to equal employment opportunity to ensure that persons are recruited, hired, trained, transferred and promoted in all job groups regardless of race, color, religion, age, disability, national origin, citizenship status, military or veteran status, sex (including pregnancy, childbirth and related medical conditions), sexual orientation, gender identity, genetic information, and any other category protected by federal, state or local law. We are not only committed to this policy by our status as a federal government contractor, but also we are strongly bound by the principle of equal employment opportunity.

Under the general guidance of the Quality Management Director, the Manager of Quality Performance plays a central role in continuously improving Alliance's quality related strategies and innovation capabilities. The candidate must be a proven people developer with a collaborative approach that builds trust within internal and external stakeholders including but not limited to clinical operations, senior and executive leadership. This position will have multiple direct reports (individual contributors) and is responsible for not only performance improvement data analysis, but also for the development, implementation, monitoring and management of specific clinical strategic interventions aimed at improving member and provider experience, member health outcomes and decreasing cost of care per capita. This position is fulltime remote. While there is no expectation of being in the office routinely, they may be required to report to the Alliance Home Office (Morrisville, North Carolina) for business meetings as needed. Responsibilities & Duties High Performing Strategy and Innovative Leadership Manages a diverse team of performance specialists and clinical quality data analysts to execute on the organization's high-priority projects Reviews and analyzes complex quality data sets to identify strategic opportunities for improvement with a sustained focus on clinical interventions geared towards member health outcomes improvement Leads multiple complex, high-risk, cross-functional, and/or highly sensitive priority initiatives engagements as a trusted thought partner to QM leadership, ensuring initiatives are directly and measurably aligned to support organizational strategy Facilitate clinical quality interventions that are evidence-based to leverage high impact activities for improving member care and outcomes Integrate, coach, support and grow a diverse highly performing strategic and innovative team; develops the team to be highly skilled and sought after internal experts Embed continuous improvement principles into the organization's strategic plan and goals Project Management and Cross-Functional Collaborations Oversee and monitor the team's project management activities including data gathering and analysis, discussion facilitation, defining, implementing and monitoring of timelines and milestones Ensure proper systems, methods and accountability practices are in place to adequately measure team efficacy and efforts where staff are deployed Evaluate performance improvement approaches and assist teams in advisement, needed to improve processes/approach Successfully engages cross-functional and inter-departmental business leads and their teams to identify problems to solve, coaches on implementation, monitors progress and mitigates risks and barriers to successful delivery of desired outcomes Influence management at all levels to secure the support and resources needed for timely and effective solution implementation Consultative Services Advises and provides consultation to a variety of internal and external stakeholders at all levels of the organization Builds effective and productive working relationships within the catchment area communities and at the State level Maintain extensive knowledge of current regulations and ensure that clinical operations comply with all the applicable requirements Audits and Reporting Ensure ongoing audit readiness of the area; conducts internal quality assurance audits and reviews as assigned Identify, escalate and mitigate issues that will significantly impact clinical interventions Effectively communicate actionable findings at all staff levels Prepare and maintain detailed reports on quality metrics including findings from audits and corrective actions and as informed by contractual requirements Minimum Requirements Education & Experience Bachelor's degree in project management, statistics, public health, business administration, organizational development, or related area of study from an appropriately accredited institution and five (5) years progressive experience (gathering, editing, and analyzing data), of which at least three (3) are supervisory or involved significant experience as a project leader in the area of assignment; or equivalent combination of education and experience. Lean Six Sigma-Green Belt Certification (or higher) and/or Project Management Professional (PMP) certification required for position Masters degree preferred Knowledge, Skills, & Abilities In-depth knowledge of Health Risk Assessments, CAPA processes and root cause analysis methodologies Awareness of industry advancements and best practices Thorough knowledge of local, state, and federal regulations and statutes governing the area of work Extensive knowledge of a variety of quality improvement methodologies - Model for Improvement, Lean, Six Sigma Extensive experience in establishing and documenting PDSA cycles and key driver diagrams Knowledge of computer-assisted statistical programs (SAS, SPSS, R, Minitab) and demonstrated ability to appropriately direct the statistical analysis of data Proven track record of leading and managing cross-functional teams in complex environments Salary Range $77,868 - $101,228/Annual Exact compensation will be determined based on the candidate's education, experience, external market data and consideration of internal equity. An excellent fringe benefit package accompanies the salary, which includes: Medical, Dental, Vision, Life, Long Term Disability Generous retirement savings plan Flexible work schedules including hybrid/remote options Paid time off including vacation, sick leave, holiday, management leave Dress flexibility

Are you passionate about significantly improving the future of medicine? Do you believe that people are the most important asset of any company? If so, join AmplifyBio ! AmplifyBio is a leading contract research organization with a comprehensive range of services that span from being an outsourcing partner for discovery stage R&D work, a preclinical CRO performing safety efficacy and toxicology studies for small molecules and advanced therapies alike, and, most recently, an expansion into manufacturing services for cell, gene, and mRNA-based therapeutics. The AmplifyBio ecosystem is comprised of three distinct business units: ADOC (South San Francisco, CA)- Amplify's Discovery, Optimization, and Characterization laboratories: ASET (West Jefferson, OH) - Amplify's Safety, Efficacy, and Toxicology Site; and the most recently opened AMEC (New Albany, OH) - Amplify's Manufacturing Enablement Center. About AMEC New Albany, OH: Amplify Bio's Manufacturing Enablement Center provides customizable cGMP suites to enable advanced therapy manufacturing in a “hoteling model,” traditional contract development and manufacturing (CDMO) or a hybrid model. Partnering with AmplifyBio for manufacturing cell therapy, gene therapy, mRNA, plasmid, or other modality is quite different from a typical CDMO experience. The goal is to provide flexible solutions customized to client needs while bringing full expert partnership. At AmplifyBio drug developers will find an innovation-rich ecosystem designed to advance a diverse range and class of pharmaceutical products across development stages. Amplify Bio is seeking to hire a Manufacturing Associate (GMP) to join our growing team!!! The Manufacturing Associate is responsible for execution of manufacturing processes within a GMP-compliant facility specializing in cell and gene therapy production at AmplifyBio's Manufacturing Enablement Center ( AMEC ) Facility. This role involves working under the supervision of senior manufacturing personnel to ensure the successful production of therapeutic products while maintaining compliance with regulatory standards and quality requirements. The Manufacturing Associate will play an essential role in supporting manufacturing operations, ensuring compliance with regulatory standards, and contributing to the advancement of cell and gene therapy products for patient treatment. What You'll Do Here: Manufacturing Execution: Execute manufacturing processes according to established SOPs, batch records, and work instructions for the production of cell and gene therapy products. Perform tasks related to drug substance and drug product processing, including cell expansion, transfection, purification, formulation, and fill/finish operation. Prepare and operate equipment, such as bioreactors, centrifuges, chromatography systems, and filtration units, following safety and operational protocols. Documentation and Compliance: Complete manufacturing documentation accurately and in accordance with GMP regulations, including batch records, logbooks, and equipment usage logs. Participate in the review and revision of manufacturing documents and procedures to ensure compliance with regulatory requirements and continuous process improvement. Assist in investigations of deviations, non-conformances, and CAPA activities, contributing to the resolution and prevention of quality incidents. Quality Control and Assurance: Perform in-process testing and sampling to monitor critical quality attributes and parameters during manufacturing operations. Assist in maintaining inventory levels for raw materials, consumables, and reagents, ensuring availability for manufacturing activities while adhering to inventory management procedures. Support equipment qualification, calibration, and maintenance activities to ensure equipment reliability and compliance with regulatory standards. Continuous Improvement: Actively participate in continuous improvement initiatives to enhance manufacturing processes, efficiency, and product quality. Provide feedback on process improvements and assist in the implementation of best practices to optimize manufacturing operations. Team Collaboration: Collaborate effectively with cross-functional teams, including manufacturing, quality assurance, quality control, and MSAT, to achieve production goals and resolve operational challenges. Communicate clearly and proactively with supervisors and team members to ensure alignment on priorities, tasks, and project timelines. We Would Love to Hear from You If: Bachelor's or associate degree in biology, bioengineering, biotechnology, or related field; or equivalent combination of education and experience. Previous experience in a GMP manufacturing environment, preferably in cell and gene therapy or biopharmaceuticals, is desirable but not required. Demonstrated ability to execute operations in controlled aseptic environments. Knowledge of GMP regulations and documentation practices is advantageous. Strong attention to detail, organizational skills, and ability to follow standard operating procedures. Excellent communication and interpersonal skills, with the ability to work collaboratively in a team-oriented environment. Flexibility to adapt to changing priorities and willingness to work in a dynamic and fast-paced environment. Ability to work independently with minimal supervision and demonstrate initiative in problem-solving and decision-making. Willingness to work flexible hours, including weekends and holidays, as needed to support manufacturing operations. At AmplifyBio , we're committed to growing and empowering an inclusive community within our company and industry. Therefore, we hire and cultivate diverse teams of the best and brightest from all backgrounds, experiences, and perspectives across our organization. AmplifyBio is an equal opportunity employer, and we value diversity at our company. We don't discriminate on the basis of race, color, citizenship status, national origin, ancestry, gender (including gender expression and gender identity), sexual orientation, age, weight, religion, creed, physical or mental disability, marital status, veteran status, political affiliation, or any other factor protected by federal, state, or local law. Why You Will Love Working Here: We take the health and happiness of our employees seriously and consistently evaluate new ways to Amp up our benefits to provide an amazing place to work. From a wellness program to financial planning and legal assistance, we make sure to take care of our own. Health, Dental, and Vision insurance that starts on your first day at Amplify Bio ! Competitive Compensation Package We take work-life balance seriously and we back it up with a UNLIMITED PTO policy. Generous paid parental leave Wellness and Self-Care Programs 401(k) match Tuition Reimbursement EAP/work-life support system A fun work environment where everyone's voice matters. We are just getting started! More benefits on the way! An Opportunity to Change the World!!! When you join our team , you will be a part of groundbreaking work while collaborating with our clients, research scientists, study directors, lab technicians, and specialists across a variety of disciplines. The future for AmplifyBio is as great as the combination of our imaginations and actions, and we hold ourselves accountable for our choices and results. We have a bias for action, excellence, and, especially, the health and safety of our employees.

The Opportunity Are you excited about supporting emerging artists Do you have a passion for musical theatre Are you creative organized and excited about the behind the scenes activities to support a special event Primary Function The Columbus Association for the Performing Arts CAPA seeks a CAPA Marquee Awards Intern to support the Education & Engagement department The CAPA Marquee Awards Internship is a great opportunity for the right candidate to gain experience in an energetic and established non profit organization This in person internship begins in late January early February We are looking for a candidate who can commit to an average of 12 15 hours per week and will be available through the CAPA Marquee Awards Showcase on Wednesday May 13 2026 Duties Responsibilities and Key Performance Objectives Key Responsibilities Assisting with marketing and research projects Various writing tasks Staffing events of various kinds Database development and input Filing and photocopying Various administrative tasks Compiling and coordinating adjudication reports Assisting with administration of master classes and workshops Creating social media content Assisting at CAPA Marquee Awards rehearsals May 4 May 13 2026 Learning Experiences Learn how to design and manage complex projects Acquire best practices for producing a high profile red carpet event Learn by observing select master classes and workshops with elite industry professionals including touring Broadway artists Develop hands on event planning experience Learn day to day operations of performing arts non profit organizations Sharpen administrative and organizational skills Gain experience in nonprofit and arts management Other Duties This job description is not designed to cover or contain an exhaustive listing of duties responsibilities and key performance objectives that are expected of the employee These items may change or new job related items may be assigned from time to time Knowledge Skills and Abilities Strong attention to detail and accuracy a must Strong organizational skills with the ability to prioritize and handle multiple projects Strong writing skills required Ability to accurately enter data Excellent communication skills Ability to maintain confidentiality and professionalism Credentials and Experience Current student working toward a degree in a related field Advanced computer skills required including experience with Office 365Must be comfortable using various social media platforms including Instagram and TikTokMust be committed to fulfilling the mission of diversity equity access and inclusion in all Education & Engagement programs Special Requirements Successful completion of a background check including BCIFBIThe majority of CAPAs public events take place at night and weekends

Job Description Our Values: Patient First | Innovation | Integrity | Determination | Trust Join us in making cure the new standard of care. At Abeona Therapeutics, we exist for our patients and their caregivers; their needs guide our decision-making. We challenge ourselves to think differently, move quickly, and deliver solutions. We hold ourselves to the highest ethical and quality standards. We persevere with resilience and focus to achieve our mission. We build trust through humility, mutual appreciation, openness, and respect. Company Description Abeona Therapeutics Inc. is a commercial-stage biopharmaceutical company focused on developing cell and gene therapies for serious diseases. Notably, Abeona's ZEVASKYN™ (prademagene zamikeracel) is the first autologous cell-based gene therapy treating wounds in adults and pediatric patients with recessive dystrophic epidermolysis bullosa (RDEB). The company's cGMP manufacturing facility in Cleveland, Ohio, is dedicated to producing ZEVASKYN™. Abeona's portfolio includes adeno-associated virus (AAV)-based gene therapies for ophthalmic diseases with unmet medical needs, and their novel AAV capsids aim to improve treatment outcomes for various debilitating conditions. Position Overview The Senior Specialist I, Quality Assurance performs routine activities associated with manufacturing of cell and gene therapy products at the Abeona Therapeutics Inc. site in Cleveland, OH. This early to mid-career position helps leads the maintenance of the quality systems in support of a cGMP Operations, corrective and preventative actions, quality events management (e.g., nonconformances, deviations, etc.), training, document management, change control, and ensuring procedural and regulatory compliance throughout the manufacturing process. The Senior Specialist I, Quality Assurance will report to the Supervisor, Quality Assurance or above. While there may be some flexibility for remote work, this position requires the candidate be available to work up to five days per week on site. Work outside of usual working hours may be required. Position is Day Shift with occasional weekends (as needed). Essential Duties and Responsibilities Review non-conformances and ensure effective corrective/preventive actions (CAPA) are implemented in a timely manner. Write new standard operating procedures or revise existing documentation utilizing document management systems. Control document lifecycle activities, including biennial review of procedures and document retention for select SOPs. Develop and present metric reporting and data analysis to help new processes or drive process improvement for quality systems. Perform training for new and existing team members, prepare training materials as necessary. Support site inspections and inspection readiness activities. Ensure the site is audit ready. Assists in internal audits of functional areas. Lead one of the following with minimal oversight: Document Control, CAPA, Deviations/Investigations, Change Controls, Training, or other key functions and cross train to support other functions. Work closely with functional groups to ensure processes and personnel remain in compliance with site procedures, regulatory and cGMP guidelines. Prioritize Quality Assurance workload as needed/priorities shift. Enhance skills via regular training and continuing education, including professional society membership/participation. Perform other duties as required. Qualifications Minimum of a Bachelor's degree in related field and/or equivalent experience. Minimum of 5 years of experience in quality and/or manufacturing in a pharmaceutical, biotech, or biologics cGMP regulated manufacturing environment preferred. Working knowledge of quality systems and ability to apply cGMPs in conformance to U.S. standards, and where appropriate, other regulatory authority standards. Working knowledge of GCP, GDP, GLP and cGMP regulations and their relevant ISO counterparts and ICH Guidelines Thorough knowledge of aseptic manufacturing processes. Excellent organizational skills, attention to detail, and Good Documentation Practices. Proficiency in MS Word, Excel, Power Point, Microsoft Office 365 and other applications. Ability to communicate and work independently with scientific and/or technical personnel. Must possess effective interpersonal, verbal, and writing skills, patience, professionalism, and the ability to effectively interact and communicate with internal staff and management. Preferred Qualifications Previous experience leading CCRB Previous experience leading a team to achieve clear results on a project Additional Competencies Excellent organizational skills, attention to detail, and Good Documentation Practices. Proficiency in MS Word, Excel, Power Point, Microsoft Office 365 and other applications. Must possess effective interpersonal, verbal, and writing skills, patience, professionalism, and the ability to effectively interact and communicate with internal staff and management. Ability to thrive in a fast-paced, patient-focused manufacturing environment with minimal direction and able to adjust workload based on changing priorities. Benefits Our values apply to how we view caring for each other as well. While the patient comes first, our employees are vital to making that happen, and so we strive to offer a competitive benefits package that includes: Medical insurance coverage (multiple options to meet our employees' and their families' needs) Dental and vision coverage 401k match plan Lifestyle spending account Compensation (annual): $74,000 - $92,000 (note: total annual compensation listed is based on annual salary and anticipated annual bonus) Physical 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. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to experience prolonged sitting, some bending, stooping, and stretching. Hand-eye coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment is required. A normal range of hearing and vision correctable to 20/20 is required. Occasional lifting up to 20 pounds is required. This is a flexible work role. This position is eligible to work remotely on a periodic basis based on site needs. The position has flexibility in conducting some work activities remotely while also having work that requires him/her to be at the office on a regular basis. All days working remotely require manager approval. Visa Sponsorship Not Currently Available IMPORTANT: Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.

Loyal is a clinical-stage veterinary medicine company developing drugs intended to extend the lifespan and healthspan of dogs. Our mission is to help dogs live longer, healthier lives. We've already achieved significant milestones on our path to earning FDA approval for the first lifespan extension drug for any species. We have three products in our pipeline and are on track for FDA conditional approval within the next year. Loyal is a well-funded startup in growth mode. Our team includes scientists, veterinarians, engineers, operators, and creatives. This role will play a key role in supporting our growth strategies. About the role We're seeking an experienced Sr. Principal, Packaging Engineering to lead all aspects of packaging process development, qualification, validation, launch readiness, and commercial supply for Loyal's small molecule, oral solid dosage (OSD) products. This role is responsible for packaging operations across the entire product lifecycle - from development through commercial execution - and will drive CDMO selection and management, packaging process development, packaging line readiness, and packaging validation (IQ/OQ/PQ). You will ensure that Loyal's packaging systems are robust, compliant, and ready to support product launch and ongoing commercial supply. The ideal candidate brings deep expertise in OSD packaging engineering, strong experience with external packaging and manufacturing partners, and the ability to deliver packaging strategies and solutions that meet regulatory, technical, operational, and commercial requirements. Experience with veterinary products is a plus but not required. This role reports to the Vice President, Manufacturing. Your daily work will include Lead packaging process development, scale-up, and optimization for OSD drug products. Drive CDMO/CMO selection, including technical evaluations, audits, contracting, and governance for packaging operations. Develop and refine packaging processes, ensuring robustness, manufacturability, and compliance with regulatory and product requirements. Lead packaging qualification and validation (IQ/OQ/PQ) for launch and commercial readiness. Oversee packaging launch readiness, including artwork, labeling, serialization, child-resistant/senior-friendly requirements, packaging components, and distribution-related packaging needs. Establish and oversee commercial packaging operations, ensuring efficiency, compliance, and long-term supply continuity. Author and contribute to packaging-related sections of regulatory submissions (Module 3), including container closure system documentation, packaging process descriptions, and responses to regulatory queries. Support or participate in PAIs and other regulatory interactions related to packaging. Conduct and oversee packaging component qualification, compatibility studies, and packaging-related stability evaluations. Troubleshoot packaging issues, conduct root-cause investigations, and lead CAPAs. Drive continuous improvement across packaging operations, materials, and systems. Collaborate cross-functionally with Manufacturing, Quality, Supply Chain, Regulatory, Formulation, and Analytical Development to ensure packaging readiness across all development and commercial stages. About you Bachelor's, Master's, or PhD in Packaging Engineering, Chemical Engineering, Mechanical Engineering, Materials Science, or a related field. 10+ years of experience in pharmaceutical or biopharmaceutical packaging engineering, with significant experience supporting commercial or late-stage OSD products. Deep expertise in small molecule, oral solid dosage packaging, including bottling, blister packaging, labeling, serialization, and container-closure systems. Proven success leading packaging process development, scale-up, qualification, and validation (IQ/OQ/PQ). Strong experience with CDMO/CMO selection, technical transfer, and day-to-day management for packaging operations. Experience supporting commercial packaging operations, including launch readiness and ongoing supply. Demonstrated ability to author packaging sections of regulatory submissions (e.g., Module 3) and respond to packaging-related regulatory questions. Strong understanding of global packaging regulatory expectations (FDA, EMA, ICH), including CR/SF requirements and serialization/traceability standards. Experience with packaging component qualification, compatibility studies, and packaging-related stability requirements. Experience supporting or participating in pre-approval inspections (PAIs) related to packaging. Demonstrated excellence in risk assessments (FMEA) and packaging investigation methodologies (RCA, CAPA). Effective cross-functional collaborator with strong project leadership and external partner management skills. Hands-on, proactive, and thrives in a fast-paced, mission-driven biotech environment. Experience launching packaging operations in a lean or emerging commercial organization. Experience with veterinary or animal health packaging is a plus. Nice to have Experience with veterinary or animal health manufacturing. Passion for Loyal's mission to bring science-driven longevity therapeutics to dogs. Salary range: $180,000 - $240,000 Loyal benefits Full-coverage health insurance - medical, dental and vision - for you and your dependents $1,000 home office equipment stipend $1,200/year learning budget for books, courses, etc. $250/month wellness budget for gym, cleaners, spa, food, etc. All 3-day weekends are turned into 4-day weekends 🎉 Unlimited vacation and paid holidays Paw-ternity leave - adopt a dog and get a day off with your new family member 🐶 Competitive salary Company equity options grant for new hires Loyal is founded and led by a first-gen female CEO and is proud to be an equal opportunity employer. We do not discriminate against applicants based on gender, race or color, ethnicity or national origin, age, disability, religion, sexual orientation, gender identity or expression, veteran status, or any other applicable characteristics protected by law. Our values Lean into moonshots We don't settle for incremental change. We have the bravery to take risks and shoot for the impact we want to have. Opportunity is at the intersection We lean into combining disciplines, expertises, and perspectives not normally adjacent. We design our organization to facilitate cross-pollination and cross-collaboration. We reject silos. Expertise without ego Titles do not determine who has a voice. We work on hard technical problems and have a ton of fun while at it. Learning by doing Our path is novel and many things we are doing have never been done before. We lean into MVPs and are open to unexpected outcomes. Lead with context We value leading with context. We equip people with the context and background necessary to make their own decisions and act in the best interest of Loyal. We empower teams to succeed. Empathy and respect for all life Our patients are not just numbers. Our work is intentional, thoughtful, and guided by respect for life. We take our responsibility to pets and pet parents seriously.

The Senior Manager, Global Product Quality - Biologics is responsible for managing quality oversight of clinical and commercial products at CMOs under contract by Otsuka to ensure that they are manufactured, packed, labelled, stored, and transported in a controlled way that is in accordance with regulatory expectations and applicable GMP/GDP quality standards. This role will provide specialized Biologics Quality Assurance support, including oversight of upstream and downstream biologics manufacturing processes, ensuring compliance with biologics-specific GMP requirements. This role has global responsibility for managing clinical and commercial product quality to ensure global supply for Otsuka's patients. **** + Provides Biologics QA support for Drug Substance and Drug Product, including upstream and downstream biologics manufacturing processes, ensuring GMP compliance for cell culture, bioprocessing, purification, and formulation activities. + Responsible for the day-to-day quality oversight of assigned GMP contract manufacturers. + Responsible for the OPDC GPQ batch record review and release activities of assigned products (API, Drug Product and Final Packaged/Labeled Investigational Medicinal Product) for use in clinical studies and commercial products. + Works collaboratively with GMP Suppliers, OPDC Technical Operations, QC and Clinical Supplies Operations, and other Otsuka Companies, Affiliates and Subsidiaries as applicable in releasing R&D products for use in clinical studies and commercial supply. + Reviews/approves deviations, investigations, CAPA plans and change controls per Otsuka Policies and Procedures. Dispositions quality system records to ensure their timely initiation, execution, and closure. + Provides quality oversight for QC-related activities that support OPDC R&D products; including LIMS data, method development & validation, method transfers and testing (release, stability). + Maintains KPIs/quality metrics to monitor performance and help drive continuous improvement activities. + Negotiates quality agreements for assigned GMP Suppliers and ensures they are established per Otsuka Policies and Procedures. + Participates in audits of GMP Suppliers to ensure compliance with local and global requirements as well as applicable regulatory requirements. + Works collaboratively with local and global Otsuka departments and GMP Suppliers in support of regulatory submissions for OPDC R&D products. Performs quality reviews of CMC sections of regulatory submissions. + Authors and maintains Standard Operating Procedures, Working Practices and Job Aids. + Works collaboratively within the Global Quality and other functional areas across Otsuka Affiliates and Subsidiaries ensure Compliance with local and global requirements and regulatory requirements. + Interfaces with project teams supporting research and development projects to assure that the goals set by the team as they relate to potential suppliers are consistent with global and local quality objectives and relevant governmental requirements. **Qualifications** Required + Bachelor's degree in Chemistry, Biology, Engineering or related Science. + Four years of combined experience in pharmaceutical/medical device industry as a manager in Manufacturing, QA or QC role supporting GMP activities for Investigational Medicinal Products or Commercial Products. + Two to three years of quality experience in managing CMOs/CDMOs (or experience in internal/external auditing). + Proven experience with biologics GMP DS and DP manufacturing, including upstream (cell culture, bioreactors) and downstream (purification, filtration, formulation) processes.as well small molecule manufacturing. + Ability to handle interactions and resolve issues with internal customers and GMP suppliers in a tactful, professional, and effective manner. + Experience in using MS Office (Word, Excel, PowerPoint). + Experience in using TrackWise. + Excellent interpersonal and communication skills. + Technical Writing Experience: writing Investigations and performing root cause analysis. + Thorough understanding of GMP requirements and the Drug Development process. + Knowledge of FDA 21 CFR Parts 210 and 211. + Experience with Pre Approval Inspections for NDAs and BLAs. + Analytical problem solving and decision-making skills. + Ability to identify gaps/risks and propose corrective and preventative actions. + Position requires approximately 20% domestic travel; Occasional international travel may also be expected. Preferred + Experience with quality oversight of controlled substances. **Competencies** **Accountability for Results -** Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change. **Strategic Thinking & Problem Solving -** Make decisions considering the long-term impact to customers, patients, employees, and the business. **Patient & Customer Centricity -** Maintain an ongoing focus on the needs of our customers and/or key stakeholders. **Impactful Communication -** Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka. **Respectful Collaboration -** Seek and value others' perspectives and strive for diverse partnerships to enhance work toward common goals. **Empowered Development -** Play an active role in professional development as a business imperative. Minimum $131,153.00 - Maximum $196,075.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate's job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws. **Application Deadline** : This will be posted for a minimum of 5 business days. **Company benefits:** Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits. Come discover more about Otsuka and our benefit offerings; ********************************************* . **Disclaimer:** This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary. Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic. If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting Accommodation Request (EEAccommodations@otsuka-us.com) . **Statement Regarding Job Recruiting Fraud Scams** At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf. Please understand, Otsuka will **never** ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment. Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters. To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website ******************************************************* . Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka's call center at: ************. If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: ******************* , or your local authorities. Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. ("Otsuka") does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka's application portal without a valid written search agreement in place for the position will be considered Otsuka's sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

We are seeking a Senior Field Quality Engineer (Remote) to drive products, service, supplier, and customer quality across the region. This role leads cross-functional efforts to identify, resolve, and prevent quality issues, ensuring that Vertiv's Quality Management System (QMS) is effectively implemented and continuously improved. The incumbent will be a key point of contact for internal and external quality audits, customer claims, supplier quality, Service quality, and will report on quality performance to senior leadership Responsibilities: Customer & Supplier Quality * Deploy, train, and audit policies, standards, and procedures for all manufacturing sites, subcontractors (3rd parties), and service operations to ensure high product and service quality. * Collaborating within business leads to taking corrective actions in response to manufacturing or service issues. * Manage customer claims: coordination, root cause analysis, corrective / preventive actions. * Lead contract reviews for customer requirements. * Coordinate customer audits; ensure improvement actions are implemented. * Support regional & global supplier quality teams and supply chain: drive supplier quality programs, supplier audits / corrective actions, documentation alignment with key suppliers. Service & Product Quality * Gain deep understanding of data impacting both service and product quality; analyze trends and metrics to identify issue areas. * Lead cross-functional teams to resolve key quality issues and inquiries based on data. * Initiate and drive continuous process quality improvements in respective areas; support roll-out of the Vertiv Operating System, with measurable progress. * Share quality best practices across the region. Quality Management Systems & Processes * Manage Process Risk Analysis / RCCM (Root Cause Corrective Measures). * Responsible for deployment, implementation, and sustainment of the Quality Management System. * Maintain all QMS documentation: trip reports, audits, inspections. * Periodically coordinate QMS reviews, report to regional leadership on system status and operations. * Perform internal audits, track and report progress. * Serve as contact / representative for external certification bodies (e.g. ISO) and lead ISO-related audits. Reporting, Compliance & Other Duties * Provide regular (e.g. weekly) reports on Key Quality KPIs, product and service issues. * Ensure communication channels are effective within the business. * Oversee special projects / assignments as assigned. * Follow all internal Quality Management System (QMS) procedures, Vertiv trade-compliance rules, health & safety (H&S) and environmental protection policies. * Report accidents, occupational illness, emergency situations; follow emergencies and operational controls as required. Qualifications (Required) * Bachelor's degree in mechanical or electrical engineering, Quality, Manufacturing, or related professional experience. * Significant experience (often 10+ years, depending on level) in quality management / engineering, including experience with product, service, and supplier quality in a manufacturing or technology environment. * Proven track record leading cross-functional teams to resolve quality issues, performing root cause analysis, corrective and preventive action (CAPA) cycles. * Experience with Quality Management Systems and ISO (or similar) certifications, including audits (internal and external). * Strong data analysis skills - experience collecting, interpreting, and acting upon quality metrics / KPIs. * Excellent communication and stakeholder management skills; ability to work across functions (manufacturing, service, supply chain, etc.). * Good understanding of risk management, process mapping, and process improvement methodologies. * Commitment to compliance, safety, environmental, H&S standards. * High confidence abilities in leading and conducting meetings and discussions * Experience in construction activities and manufacturing facilities * Strong communication skills Preferred Skillsets * Advanced degree or certification in quality management (e.g. Six Sigma, CQE, ISO Lead Auditor). * Experience with Vertiv or similar critical infrastructure / technology / manufacturing companies. * Mechanical, thermal, electrical, liquid cooling systems knowledge and experience and/ or advanced knowledge PHYSICAL & ENVIRONMENTAL DEMANDS * Climb ladders, roof structural equipment, confined spaces, construction sites, a variety of environmental conditions TIME TRAVEL REQUIRED * 75% travel

Our team members are at the heart of everything we do. At Cencora, we are united in our responsibility to create healthier futures, and every person here is essential to us being able to deliver on that purpose. If you want to make a difference at the center of health, come join our innovative company and help us improve the lives of people and animals everywhere. Apply today! Job Details Shift: Sun-Thurs 11pm-7:30am Primary duties and responsibilities: * Develops and analyzes metrics and data that drive continuous improvement. * Develops, improves, and maintains task, department, and general SOPs in accordance to cGMPs. * Responsible for mentoring and training initiatives to improve workforce skill set. * Leads 5S + Safety initiatives facility wide. * Assists in the hiring and supports new operator onboarding process. * May trouble shoot and repair packaging equipment. * May assist with set ups, packaging duties and quality checks before, during and after packaging runs. * Responsible for various record keeping activities including but not limited to batch records and shift reports. * Competent in editing batch records and compiling constructive narrative information pertaining to batch production. * People leadership skills and tools will be enhanced and developed through self-paced learning, such as assigned readings, seminars, formal training, and classes, as well as through an assigned mentor/coach. * Completes accident/incident reports and conducts investigation. Participates in follow-up meetings and CAPA. * Supports internal and external quality investigations. * Will be responsible for daily operations within the department including, but not limited to, time management, payroll, PTO, and performance management. * Initiates SOP/WI revisions as needed to assure compliance and continuous improvement. * Performs related duties as assigned. Experience and Requirements: * High School diploma or equivalent required. At least three (3) years of experience in a pharmaceutical production or manufacturing concepts, practices, and procedures preferred. Minimum Skills, Knowledge and Ability Requirements: * Ability to lead and manage teams. * Ability to read and understand the English language for the purpose of following instructions and instruction others. * Ability to develop and maintain cooperative working relationships with others. * Ability to use good judgment in order to carry out detailed instructions. * Ability to work independently and lead others. * Ability to handle a variety of tasks simultaneously. * Good verbal and written communication skills. * Attention to detail and intermediate skills with MS Office. * Basic understanding of KPIs for manufacturing operations. * Required to work various shifts, hours and weekends. Work Environment: * The work environment characteristics described here are representative of those an associate encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions: The noise level in the work environment is generally quiet. PHYSICAL AND MENTAL REQUIREMENTS: * The physical demands described here are representative of those that must be met by an associate to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions: * Ability to operate in a production-driven environment and perform at a high level. * Physical activity requiring reaching, bending, kneeling, stooping, lifting, finger dexterity, grasping, feeling, repetitive motions, talking and hearing. * Ability to lift up to 50 lbs. * Visual requirement is for close vision, distance vision, peripheral vision and ability to adjust focus. * Associate is required to stand, walk (or otherwise be mobile). * Ability to deal with stressful situations as they arise. * Ability to operate equipment such as forklifts, pickers, etc. What Cencora offers We provide compensation, benefits, and resources that enable a highly inclusive culture and support our team members' ability to live with purpose every day. In addition to traditional offerings like medical, dental, and vision care, we also provide a comprehensive suite of benefits that focus on the physical, emotional, financial, and social aspects of wellness. This encompasses support for working families, which may include backup dependent care, adoption assistance, infertility coverage, family building support, behavioral health solutions, paid parental leave, and paid caregiver leave. To encourage your personal growth, we also offer a variety of training programs, professional development resources, and opportunities to participate in mentorship programs, employee resource groups, volunteer activities, and much more. For details, visit ************************************** Full time Equal Employment Opportunity Cencora is committed to providing equal employment opportunity without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, age, disability, veteran status or membership in any other class protected by federal, state or local law. The company's continued success depends on the full and effective utilization of qualified individuals. Therefore, harassment is prohibited and all matters related to recruiting, training, compensation, benefits, promotions and transfers comply with equal opportunity principles and are non-discriminatory. Cencora is committed to providing reasonable accommodations to individuals with disabilities during the employment process which are consistent with legal requirements. If you wish to request an accommodation while seeking employment, please call ************ or email ****************. We will make accommodation determinations on a request-by-request basis. Messages and emails regarding anything other than accommodations requests will not be returned Affiliated Companies Affiliated Companies: Amerisource Health Services, LLC USA > OH > Columbus > John Glenn Salary 1

The Quality Control (QC) Auditor is responsible for performing detailed audits of KnippeRx pharmacy and contact center operations to verify compliance with internal Standard Operating Procedures (SOPs), accreditation standards (NABP, ACHC), and regulatory requirements. This position supports the Compliance and Quality teams by conducting transaction-level reviews, validating CAPA effectiveness, and identifying process improvement opportunities to prevent recurrence of errors or compliance gaps. The QC Auditor reports to the Compliance Manager and works collaboratively with Operations, Quality, and Client Services teams to maintain a culture of continuous compliance and patient safety. Responsibilities Quality Control Auditing Perform daily, weekly, and targeted audits of pharmacy dispensing, order verification, data entry, and patient support transactions to confirm compliance with SOPs, regulatory requirements, third party payer contracts, and program-specific client rules. Audit for accuracy in prescription processing, patient communication documentation, and billing or reimbursement workflows. Conduct retrospective file reviews to ensure completeness, accuracy, and compliance with HIPAA, DEA, and accreditation standards. Document findings in a standardized audit log, and provide clear, evidence-based feedback to responsible departments. Assist in developing and refining audit checklists and scoring methodologies to align with evolving compliance and operational needs. Participate in readiness reviews for NABP, ACHC, board of pharmacy, and client audits to verify document accuracy and adherence to quality standards. CAPA Verification and Continuous Improvement Support the Compliance Manager and Quality team in monitoring CAPA completion and verifying the effectiveness of corrective actions. Conduct post-CAPA follow-up audits to validate that corrective and preventive measures are fully implemented and sustained. Track recurring trends and escalate repeat deficiencies to leadership with risk-based prioritization. Partner with process owners to provide feedback on procedural gaps, training needs, or system improvements. Contribute to CAPA documentation by providing audit data and evidence supporting resolution or ongoing monitoring. Documentation and Reporting Maintain organized and auditable records of all quality control reviews, including findings, recommendations, and follow-up actions. Prepare weekly and monthly audit summary reports for review by the Compliance Manager and Compliance Committee. Support external and client audits by providing requested documentation and demonstrating internal control processes. Assist in developing dashboards or scorecards summarizing audit performance, compliance trends, and error reduction metrics. Compliance and Accreditation Support Support KnippeRx accreditation readiness by ensuring compliance with NABP, ACHC, and state board requirements. Conduct internal spot checks for accreditation-related process controls such as patient communication documentation, pharmacist review, and complaint resolution tracking. Verify that staff training and licensure requirements are up to date as part of accreditation compliance monitoring. Participate in internal mock audits and provide recommendations for continuous improvement. Training and Process Improvement Assist in developing training materials and conducting refresher sessions based on recurring audit findings. Provide real-time coaching feedback to technicians or agents when process deviations are identified. Support process improvement projects by contributing audit-based insights to improve workflow efficiency and reduce risk. The above duties are meant to be representative of the position and not all-inclusive. Qualifications MINIMUM JOB REQUIREMENTS: High School diploma or equivalent, Bachelor Degree strongly preferred One (1) year of previous pharmacy technician experience with exposure to all functional areas (Prescription data entry, medical records, etc.) Pharmacy Technician Certification (CPhT) preferred; active or eligible for registration in at least one state. Minimum 3-5 years of experience in specialty pharmacy, mail-order pharmacy, or quality/compliance auditing environment. Knowledge of NABP, ACHC, HIPAA, and DEA regulations related to pharmacy operations. KNOWLEDGE, SKILLS & ABILITIES: Strong attention to detail and analytical skills with ability to identify root causes and recommend solutions. Proficient with Microsoft Excel, SharePoint, and compliance tracking systems (e.g., Trackwise,ZenQMS, MasterControl, or equivalent). Excellent written communication and documentation skills. Ability to work independently and manage multiple audit priorities in a fast-paced environment. Advanced knowledge of medical terminology (including sig codes and Roman numerals), brand and generic names of medications, and general pharmacy terminology Accuracy: Maintains high standards of precision in reviewing operational transactions. Accountability: Owns findings and follows through to ensure CAPA completion. Compliance Mindset: Understands and reinforces regulatory and accreditation standards. Critical Thinking: Identifies patterns and proposes actionable solutions. Collaboration: Works effectively with cross-functional teams to resolve audit findings. Excellent organization skills and detail oriented Ability to accept ambiguity at times and apply decision making skills to determine course of action Ability to follow established process flows Ability to perform accurately and efficiently Basic math skills Strong understanding and practice of data entry, medical records, and dispensing systems and equipment Ability to possess and obtain knowledge of medication names - generic and trade Ability to recognize subtle differences in names and numbers Ability to work effectively in highly stressful situations, exhibiting flexibility in changing situations Recognizes the importance of patient safety PHYSICAL DEMANDS: Location of job activities 100% inside Extensive manual dexterity (keyboarding, mouse, phone) Use of phone for communication Sit for prolonged periods of time Ability to travel out of state 25% Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.

Specialist providers of pharmaceutical automation, process and project controls. Skellig was founded to radically improve upon the way automation, process, and project controls are provided. It's a goal that is grounded in efficiency, transparency, and our client's total peace of mind - this is the vision behind everything we do. At Skellig Automation, we empower great people to do great work in the Life Sciences industry. Our engineers provide premier automation services with one common goal: to make medicine more affordable and accessible for all by reducing the cost of manufacturing. We work alongside other industry leaders in laying the foundation for true technological innovation and guiding our partners towards modern process solutions. Whether working within the traditional automation stack or championing Industry 4.0 systems, Skellig has a place for creative engineers with a passion for bringing the Life Sciences into the future. Position Summary The IT Quality Specialist is responsible for ensuring the compliance, integrity, and continuous improvement of computerized systems within the pharmaceutical environment. This role focuses on executing and maintaining IT Production Operations and Technology (PO&T) department deliverables, including periodic reviews, CAPA and deviation management, user access review, validation document review, and the development of standard operating procedures (SOPs), work instructions (WIs), and job aids. The IT Quality Specialist collaborates with cross-functional teams to maintain adherence to regulatory requirements (e.g., FDA, EMA, GxP) and internal quality standards. Key Responsibilities Draft, execute, and manage computerized system periodic reviews in accordance with regulatory and company requirements. Manage CAPAs and deviations, ensuring timely investigation, root cause analysis, and effective corrective/preventive actions. Review and approve validation deliverables (e.g., URS, IQ/OQ/PQ, test scripts, summary reports) for compliance with GxP and data integrity requirements. Draft, revise, and maintain SOPs, Work Instructions, and job aids to ensure alignment with current regulatory expectations and internal processes. Partner with IT, Quality, and Business stakeholders to support audits, inspections, and continuous improvement initiatives. Monitor trends in IT quality events and provide input into risk assessments and process improvements. Ensure documentation practices are consistent with data integrity principles (ALCOA+). Qualifications Bachelor's degree in Computer Science, Information Systems, Life Sciences, Engineering, or related discipline (or equivalent experience). 3+ years of experience in IT Quality, Computer System Validation (CSV), or related Quality roles within the pharmaceutical or life sciences industry. Strong understanding of GxP regulations (21 CFR Part 11, Annex 11, FDA, EMA, ICH guidelines). Hands-on experience with CAPA/deviation management systems and periodic review processes. Excellent technical writing skills for SOPs, WIs, and job aids. Ability to work cross-functionally and communicate effectively with both technical and non-technical stakeholders. Strong analytical and problem-solving skills with attention to detail. Preferred Qualifications Experience with electronic systems such as Veeva QualtiyDocs, TrackWise, or equivalent. Familiarity with audit/inspection management. Knowledge of pharmaceutical manufacturing and laboratory systems (e.g., LIMS, MES, ERP). Contact: Should you have any questions please contact our Head of Recruiting: ************************ From its inception, Skellig has strived to be ‘more human.' We work hard to foster a culture that promotes innovation, diversity, and great work. A culture that rewards problem solving, teamwork, and service excellence. And one that attracts the top talent and premier clients. Ours is a culture of honesty, transparency, and kindness - A people-focused and compassionate company.

Coffee is "wakeup technology" that has not materially improved in 1,500 years. We are changing that. 50% of Americans have a gene variant that makes metabolizing caffeine difficult, causing jitters, bloating, and stomach problems. Most people shrug their shoulders and say, "Welp, that's coffee." Instead of shoulder shrugging, we've developed a priority blend of coffee, functional mushrooms, collagen protein, and nootropics to promote focus, energy, immunity, and gut health. No crash. No B.S. We've served 300,000 customers in the past 3 years. There are 150,000,000 coffee drinkers left. We're less than 1% done. Come join us for the remaining 99%. We're looking for a Director of Supply Chain who will lead ingredient sourcing, quality control, and S&OP processes to ensure consistent, high-quality, and cost-efficient product delivery. This role owns the full supply chain lifecycle, from sourcing functional ingredients and packaging through production, fulfillment, and demand planning alignment, working closely with Operations, Finance, and Product Development. The ideal candidate is both strategic and operationally hands-on, quality expert, a strong communicator, negotiator, and Excel expert who can translate data into actionable insights and solve complex supply chain challenges with speed and precision. Requirements 7-10 years of experience in supply chain, sourcing, or operations, preferably in food, beverage, or CPG. Strong understanding of functional ingredient sourcing, import/export regulations, and food quality standards. Proven track record implementing S&OP and supplier quality systems. Experience managing co-manufacturers and international vendors (China, U.S., etc.). Excellent negotiation, analytical, and project management skills. Deep expertise in Excel, including pivot tables, Power Query, Power BI, Power Pivot, complex formulas, scenario modeling, and dashboard creation. Familiarity with ERP/WMS tools (e.g., NetSuite, ShipBob) and data reporting systems. Bachelor's degree in supply chain management, Operations, Food Science, or related field (MBA preferred). Key Responsibilities Ingredient & Packaging Sourcing Develop and manage sourcing strategies for all raw materials, including functional mushrooms, collagen, and nootropic ingredients. Identify and qualify new suppliers to ensure security of supply, cost competitiveness, and compliance with Everyday Dose quality standards. Negotiate supplier contracts and manage total landed cost, freight terms (DDP/FOB), and tariff implications. Partner with Product Development on new product formulations to source sustainable and compliant ingredients. Quality Control & Vendor Management Implement and maintain the company-wide Quality Control Program covering raw materials, packaging, and finished goods. Oversee vendor qualification audits, supplier scorecards, and corrective action processes (CAPA). Establish and monitor AQL inspection programs, COA verification, and golden sample standards. Drive quality performance improvements with suppliers and co-manufacturers to reduce defect rates and non-conformances. S&OP (Sales & Operations Planning) Govern all functions of S&OP to align on a demand forecast, production plans, and inventory purchases and targets. Own supply planning and capacity modeling for contract manufacturers and fulfillment partners. Collaborate with Finance to ensure forecast accuracy and production efficiency align with company P&L targets. Monitor inventory health (DOH, stockouts, excess/obsolete) and implement proactive mitigation strategies. Reporting, Analytics & Excel Systems Build and automate robust reporting dashboards for demand forecasting, supplier performance, cost tracking, and inventory analysis. Design advanced Excel models for what-if scenarios, margin analysis, MOQ optimization, and capacity planning. Create visual reports and summaries that drive data-informed decisions across Operations, Finance, and Leadership. Operations & Fulfillment Alignment Partner with fulfillment and logistics teams to ensure timely delivery of materials to co-manufacturers and finished goods to customers. Manage production scheduling, co-man inventory levels, and raw material flow to prevent delays or shortages. Support fulfillment center quality audits and inbound inspection protocols. Continuous Improvement & Systems Implement operational best practices for sourcing, quality, and planning processes. Leverage data tools (e.g. ShipBob WMS, Looker) for visibility and reporting. Drive continuous improvement in supplier performance, lead time reduction, and working capital efficiency. Benefits Be part of a mission-driven company revolutionizing the way people start their day. Competitive salary with performance-based incentives. Equity opportunities in a rapidly growing brand. Flexible, remote work environment. A passionate and innovative team that values creativity and collaboration. Ready to help us fuel the future of coffee? Apply now and let's build something extraordinary together.

+ This position supports client's Quality Assurance program under the Plant QA organization providing daily oversight of the Drug Product manufacturing areas. + The ideal candidate is a detail-oriented Quality Assurance professional with at least 2 years of GMP experience in a regulated manufacturing environment, preferably within pharmaceuticals or medical devices. + They should bring a solid understanding of QA documentation processes, including change controls, equipment qualifications, and master data approvals, and be comfortable working within SAP or EPR systems. + Strong project coordination skills and organizational discipline are essential, as this role supports a large-scale product launch and will require managing multiple deliverables on tight timelines. + A background in process development, manufacturing, or digital quality innovation is highly desirable. **Responsibilities:** + Under general supervision, the role provides support and compliance oversight to Manufacturing and Facilities & Engineering staff in the execution of their processes, procedures, and use of quality systems. + Duties include presence on the shop floor, electronic batch record review, SOP revision approval, work order approval, and quality approval of minor deviations and CAPA records. + Responsibilities will include evaluation of compliance issues, providing recommendations, and assuring progress of quality records, including Process and Equipment Validation Documents to completion. + The QA Specialist will also represent QA Functional area in the execution of projects necessary to achieve departmental operational goals. **Preferred Qualifications:** + Bachelor's Degree in Engineering, Biochemistry, Biology, Chemistry, or related science field. + Demonstrated ability to perform GMP operations including following detailed SOPS, maintaining training, and good documentation practices. + Experience managing projects through to completion meeting timelines. + Evaluating documentation and operations according to company procedures. + Experience working with Quality Systems Strong organizational skills and ability to manage multiple tasks at one time + Effective communication skills (both written and verbal). + Demonstrated ability to work as both a team player and independently. + Display leadership attributes and drive improvement initiatives. **Top 3 must have skills:** + Experience in and knowledge of GMP/GCP operations or similarly regulated industry + Affinity with digital innovation, data sciences and Quality engineering + Highly effective verbal and written communication skills, strong interpersonal skills + Great attention to detail and high degree of accuracy in task execution and GMP documentation + Ability to complete tasks autonomously, providing updates to senior management, and identifying potential issues. **About US Tech Solutions:** US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visit *********************** . "US Tech Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran"

About Forge At Forge Biologics, we believe in turning bold ideas into life-changing realities. Our mission is simple yet powerful: to enable access to life-changing gene therapies and help bring them from idea into reality. We partner with scientists, physicians, biotech and pharma innovators, and patient communities - all united by one goal: improving lives. If you're driven by purpose and excited to make a tangible impact, this is where your journey begins. Our team works out of The Hearth, a state-of-the-art, 200,000-square-foot cGMP facility in Columbus, Ohio. Here, you won't just watch innovation happen - you'll be part of it. Whether you're scaling AAV manufacturing, collaborating on cutting-edge therapies, or supporting complex technical projects, you'll play a key role in bringing hope to patients with genetic diseases. About The Role The Lead, GMP Manufacturing Support plays a critical role in maintaining and supporting GMP-compliant cleanroom environments (ISO 5-8 / Grade A-D) essential for the production of viral vector products. This role is responsible for overseeing contamination control strategies, coordinating day-to-day operations, and leading a team of personnel responsible for cleaning and GMP support activities. The ideal candidate brings a strong understanding of aseptic practices, contamination control, and GMP regulations, along with the leadership skills to promote a high standard of compliance, safety, and operational excellence. What You'll Do: Lead the cleanroom cleaning team to perform routine and non-routine cleaning operations per SOPs and GMP requirements. Oversee cleaning of aseptic fill areas, upstream/downstream suites, airlocks, corridors, and equipment in accordance with validated procedures. Perform verification of cleaning and sanitization activities and ensure accurate documentation; perform the manufacturing review of logbooks and associated documents; and resolve out-of-trend situations promptly. Act as SME for cleanroom behaviors, gowning, and contamination control best practices. Support deviation investigations, root cause analysis, and CAPA development related to cleaning issues or contamination events. Plan and assign daily tasks for effective resource utilization, collaborating with planning, and maintaining schedules. Train and coach new and existing staff on cleaning techniques, gowning, aseptic behavior, and cleanroom discipline. Collaborate with Manufacturing, Quality Assurance, Quality Control, Environmental Monitoring, and Facilities & Engineering to resolve issues and drive continuous improvement. Support cleaning validation and requalification activities for classified spaces and equipment. Manage cleanroom inventory to ensure availability of common-use items and uninterrupted operations. Oversee consumable expiration tracking and storage, implementing rotation protocols and guiding technicians to meet operational and regulatory standards. Other responsibilities may include supporting tubing sets preparation, process improvement initiatives and collaborating with cross-functional teams to ensure the efficient production of gene therapy products. May assist with preparing for regulatory inspections (FDA, EMA) as the subject matter expert for contamination control practices. What You'll Bring: Associate's or Bachelor's degree in a relevant scientific field (e.g., Biology, Chemistry, Engineering) or equivalent experience. Minimum 5 years of experience in a GMP manufacturing environment, preferably in biologics, gene therapy, or sterile manufacturing. Demonstrated leadership skills with experience overseeing or mentoring team members. Strong understanding of cleanroom classifications, contamination control principles, and GMP regulations. Experience working within a Quality Management System (QMS). Proven experience overseeing manufacturing support functions (e.g., cleaning and sanitization, tube set building and setup). Excellent communication, organization, and problem-solving skills. Exceptional computer skills, prior experience with a manufacturing software (e.g., MRP or ERP System), and ability to use data analytics to drive process improvements and results. Flexibility to work in shifts, including weekends and holidays, as required by manufacturing production schedules. Ability to work in classified cleanroom environments (ISO 5-8 / Grade A-D) for extended periods while fully gowned in aseptic/sterile PPE attire. Able to lift up to 40 pounds and remain standing or walking for extended periods throughout the shift. The work environment is fast paced. This position has the utmost responsibility for compliance with rules and regulations regarding a safe and collaborative work environment relative to actions and conduct. Other duties may be assigned in addition to those described that aligns with company objectives. Physical Requirements: This position works in both a laboratory environment and typical office environment where the physical work demands will vary depending on the specific tasks and duties required of the job. The employee will be stationary (standing/sitting) for extended periods of time. Employees regularly wear personal protective equipment based on the task being performed such as cleanroom gowning. Must be able to work in a confined space, such as a clean room or laboratory environment. Ability to identify small details within the field of vision, distinguish between different colors, and accurately identify objects within a specific area. This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee. Duties, responsibilities and activities may change or new ones may be assigned. Forge Biologics is an equal opportunity employer dedicated to building an inclusive and diverse workforce. Forge Biologics, provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. Forge Your Future with Us What sets Forge apart is our culture of H.O.P.E. We are hardworking, showing up each day with determination and grit. We are open, creating a space where ideas flow freely and every voice is valued. We are purpose-driven, with every task directly tied to changing lives. And we are engaged, energized by the challenges we face and the milestones we achieve together. At Forge, your growth matters. We're committed to helping you expand your skills, take on new challenges, and develop your career through mentorship, hands-on learning, and opportunities for advancement. Our people are our greatest investment, and we're proud to see team members grow with us. If you're ready to use your talent to help deliver hope to patients around the world, join us - and be part of something bigger than yourself. We've Got You Covered We take the health and happiness of our employees seriously and are consistently evaluating new ways to make our benefits truly UnFORGEttable. Health, Dental, and Vision insurance that starts on your first day at Forge, with 90% of premiums covered for team members as well as dependents Competitive PTO (plus 14 paid company holidays) Annual bonus for all full-time employees 401(K) company match Fully-stocked kitchen with free food/drinks Onsite gym 12 weeks of paid parental leave - additional discount programs include childcare support & dependent care Employee Assistance Program Wellness benefits (financial planning services, mental health counseling, employer paid disability) Professional & Personal development resources

Business Unit: Ops DTI Employment Type: Contract . Rate: $50 - $60/hour W2 DOE with Benefits Posting Date: 04/04/2025. Notes: Only qualified candidates need apply. 3 Key Consulting is hiring! We are recruiting an Engineer Senior, Business & Automation Systems Validation for a consulting engagement with our direct client, a leading global biotechnology company. Job Description: Primarily responsible for ensuring adherence to computer validation standards and procedures for computer-related systems. Responsibilities include participation in system design, preparation of test protocols, analysis of test results and preparation of summaries. Provides guidance and sets standards in producing quality documentation, serves as the liaison between the IS and Quality functions, provides testing and IT compliance guidance, and provides timely and effective response and follow-through in the resolution of IT Quality/Project compliance issues. This role is for a strong background in IT Business systems validation, IT Automation systems validation, ensuring that our Information technology systems and processes meet regulatory requirements and industry standards, particularly within the framework of GxP (Good manufacturing Practice) in projects. Integrates a variety of systems technologies to provide systems related solutions to meet business needs. Supports the creation and maintenance of our client's Ohio's computer systems validation. • Perform Deviations, CAPA, Change records for Technology computer systems (E.g: MES, SCADA, ASRS, ServiceNow, QBAS, SAP/ERP, Serialization, etc). • Provide support to system owners on completion of Design Specifications, URS, Traceability, IQ (Installation Qualification), OQ (Operational Qualification), PQ (Performance Qualification) draft copies. • Provide support to complete the validation deliverables as required per the project. • Develop and execute test scripts in ALM, Kneat test tools to support system owners/IT Application Owners. • Ensure and track computer systems periodic reviews and periodic access reviews are completed as per schedule to maintain system maintenance phase. • Perform system periodic reviews for Computerized systems, Automation systems. • Familiar with validating SCADA, MES, PI Factory Talk Historian, Serialization systems. • Ensures that systems are maintained in a compliant manner according to the Technology quality systems standards. • Support regulatory inspections and internal audits as required. Top Must Have Skill Sets: • Experience with ALM or Kneat testing tool is plus. • Experience with ServiceNow (Problem, Change management), Track wise (Change Management), Veeva (Document management, CAPA, Deviations, Change Management). • Knowledge of cGMP regulations and guidelines including but not limited to U.S. code of Federal Regulations 21 CFR Part 11 and Part 211. • Understanding of industry standards and best practices for computer system validation such as GAMP 5. • Perform Deviations, CAPA, Change records for Technology computer systems (E.g: MES, SCADA, ASRS, ServiceNow, QBAS, SAP/ERP, Serialization, etc). Day to Day Responsibilities: • Perform Deviations, CAPA, Change records for Technology computer systems (E.g: MES, SCADA, ASRS, ServiceNow, QBAS, SAP/ERP, Serialization, etc). • Provide support to system owners on completion of Design Spec, URS, Traceability, IQ (Installation Qualification), OQ (Operational Qualification), PQ (Performance Qualification) draft copies. • Provide support on completion of validation deliverables as required per the project. • Develop and execute test scripts in ALM, Kneat test tools to support system owners/IT Application Owners. • Ensure and track computer systems periodic reviews and periodic access reviews are completed as per schedule to maintain system maintenance phase. • Ensures that systems are maintained in a compliant manner according to the DTI quality systems standards. • Support regulatory inspections and internal audits as required. Basic Qualifications: • Bachelor's or Master's Degree in a science or Engineering discipline required. • 7+ years relevant experience in computer system validation (E.g: MES, SCADA, PI Factory Talk Historian, Building Management system (BMS, QBAS), Serialization, QC systems). • Basic Qualifications Red Flags: • No experience on computer validation process. • No background from life Sciences/Bio Technology. • No experience on system deviations, CAPA, Change management. • No knowledge on data integrity ALCOA, ALCOA+ principles. Interview Process: Webex, or In-person We invite qualified candidates to send your resume to **************************. If you decide that you're not interested in pursuing this particular position, please feel free to take a look at the other positions on our website ******************************* You are also welcome to share this opportunity with anyone you think might be interested in applying for this role. Regards, 3KC Talent Acquisition Team

Since its inception over a decade ago, CRISPR Therapeutics has transformed from a research-stage company advancing programs in the field of gene editing, to a company with a diverse portfolio of product candidates across a broad range of disease areas including hemoglobinopathies, oncology, regenerative medicine, cardiovascular and rare diseases. The Nobel Prize-winning CRISPR science has revolutionized biomedical research and represents a powerful, clinically validated approach with the potential to create a new class of potentially transformative medicines. To accelerate and expand its efforts, CRISPR Therapeutics has established strategic partnerships with leading companies including Vertex Pharmaceuticals. CRISPR Therapeutics AG is headquartered in Zug, Switzerland, with its wholly-owned U.S. subsidiary, CRISPR Therapeutics, Inc., and R&D operations based in Boston, Massachusetts and San Francisco, California, and business offices in London, United Kingdom. Position Summary This position will be responsible for building, managing, and administering CRISPR's Quality Management System, specifically the Deviation, Change Control and CAPA processes. The candidate will administer Kivo QMS and will ensure compliance with established procedures. Enhancement of existing procedures, and creation of new best practices will be a critical component of this role. Responsibilities Lead the QMS Program, specifically the deviation, CAPA, & change control programs Develop, improve, and administer the QMS Program Act as Kivo QMS business administrator Provide subject matter expertise to improve the QMS Develop and improve Quality department procedures Train new users on Kivo QMS Ensure compliance with approved CRISPR procedures as they relate to the creation and approval of QMS records Coordinate periodic review of QMS records Generate metrics to ensure on-time record closure and identify corrective actions Develop and present QMS metrics to management Create best practices for authoring technical investigations, root cause analysis tools, and corrective and preventive actions Meet with QMS record owners and participants to ensure proper system usage Support internal and external audits related to the QMS Enhance the Quality Culture by being a proactive and professional resource for the business. Minimum Qualifications Minimum of 10+ years' experience in related Biopharmaceutical QMS roles Experience in Biopharmaceutical QA and/or Quality System improvement roles is preferred BA or BS is preferred though long-time experience in QA may be acceptable Strong organizational skills and attention to detail Strong interpersonal skills Computer skills and previous experience with eQMS Ability to provide subject matter expertise regarding QMS implementation and administration Systems Administration experience Preferred Qualifications MS or advanced degree Experience with Gene Therapy / Cell Therapy products Previous experience with Kivo QMS Computer System validation experience Entrepreneurial and results driven Project Management experience MS Office proficiency Competencies Collaborative - Openness, One Team Undaunted - Fearless, Can-do attitude Results Orientation - Delivering progress toward our mission. Sense of urgency in solving problems. Entrepreneurial Spirit - Proactive. Ownership mindset CRISPR Therapeutics believes in fostering a dynamic workplace that balances remote work flexibility with the benefits of in-person interactions. Our employees work at least three days on-site, creating a collaborative work environment, where we cultivate mentorship opportunities, increase cross-functional communication and offer opportunities for our employees to connect. Certain lab based and manufacturing positions are located fully on-site. Senior Manager: Base pay range of $140,000 to $160,000+ bonus, equity and benefits The range provided is CRISPR Therapeutics' reasonable estimate of the base compensation for this role. The actual amount will be based on job-related and non-discriminatory factors such as experience, training, skills, and abilities. CRISPR Therapeutics, Inc. is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. To view our Privacy Statement, please click the following link: ***********************************************