Quality Control Analyst jobs at Seagen - 93 jobs

The Patient Experience QC Analyst provides cross-functional program leadership to launch new processes and improve existing ones. They use project management tools to drive collaboration across departments, conduct root cause analyses, track progress, and provide detailed reports to management. This role ensures the team meets project objectives on time while maintaining accuracy, professionalism, and adherence to established processes within the Patient Experience team. Primary Responsibilities: Drive collaboration and coordination with cross-functional teams, including programmers, engineers, and management. Track team progress and deliver detailed status reports, including KPIs and performance data. Participate in CAPA reviews to identify training and process improvement opportunities. Support patient-focused teams with quality improvement, tracking, and performance projects. Create and maintain documentation such as SOPs and protocols. Partner with management and data analysts to identify new process improvement opportunities. Audit call and email communications to assess quality and accuracy; compile QA feedback summaries for management and training teams. Follow established protocols when delivering feedback to Patient Experience agents and leadership. Qualifications: Bachelor's degree or equivalent required 2+ years of call center QC experience 5+ years of additional professional experience Knowledge, Skills, and Abilities: Strong analytical skills with proficiency in MS Excel and data dashboards (e.g., QlikSense, QlikView) Excellent communication, organization, and cross-functional collaboration Creative data-gathering and research skills Strong interpersonal and listening skills Hypothesis-driven mindset and passion for improving patient experience Strong problem-solving skills and ability to deliver timely results The pay range is listed and actual compensation packages are based on a wide array of factors unique to each candidate, including but not limited to skill set, years & depth of experience, certifications and specific office location. This may differ in other locations due to cost of labor considerations.Remote USA$30-$38 USD OUR OPPORTUNITY Natera™ is a global leader in cell-free DNA (cf DNA) testing, dedicated to oncology, women's health, and organ health. Our aim is to make personalized genetic testing and diagnostics part of the standard of care to protect health and enable earlier and more targeted interventions that lead to longer, healthier lives. The Natera team consists of highly dedicated statisticians, geneticists, doctors, laboratory scientists, business professionals, software engineers and many other professionals from world-class institutions, who care deeply for our work and each other. When you join Natera, you'll work hard and grow quickly. Working alongside the elite of the industry, you'll be stretched and challenged, and take pride in being part of a company that is changing the landscape of genetic disease management. WHAT WE OFFER Competitive Benefits - Employee benefits include comprehensive medical, dental, vision, life and disability plans for eligible employees and their dependents. Additionally, Natera employees and their immediate families receive free testing in addition to fertility care benefits. Other benefits include pregnancy and baby bonding leave, 401k benefits, commuter benefits and much more. We also offer a generous employee referral program! For more information, visit *************** Natera is proud to be an Equal Opportunity Employer. We are committed to ensuring a diverse and inclusive workplace environment, and welcome people of different backgrounds, experiences, abilities and perspectives. Inclusive collaboration benefits our employees, our community and our patients, and is critical to our mission of changing the management of disease worldwide. All qualified applicants are encouraged to apply, and will be considered without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, age, veteran status, disability or any other legally protected status. We also consider qualified applicants regardless of criminal histories, consistent with applicable laws. If you are based in California, we encourage you to read this important information for California residents. Link: ********************************************************************** Please be advised that Natera will reach out to candidates with ************* email domain ONLY. Email communications from all other domain names are not from Natera or its employees and are fraudulent. Natera does not request interviews via text messages and does not ask for personal information until a candidate has engaged with the company and has spoken to a recruiter and the hiring team. Natera takes cyber crimes seriously, and will collaborate with law enforcement authorities to prosecute any related cyber crimes. For more information: - BBB announcement on job scams - FBI Cyber Crime resource page

Schedule: 3:00 pm - 11:00pm with rotating weekends and holidays, Full-Time, Benefits Eligible Performs accurate and timely processing, testing, and resulting. Provides preventive maintenance, quality control, and customer service. Job Description: Essential Functions: Performs routine and complex technical procedures and functions in the laboratory information system in an adequate and timely manner; may include phlebotomy, specimen collection, processing, reporting, and storage. Performs preventive maintenance, supply upkeep, and quality control with appropriate documentation, coordination, and communication. Demonstrates knowledge of and upholds applicable laws and regulations related to position. Maintains knowledge of techniques, procedures, and protocols lab-wide and within lab section. Reviews and acknowledges procedures as required. Delivers service excellence, One Team collaboration, and quality patient care through adjusting communication styles to adapt to various cultural differences, addressing concerns by researching problems and identifying resolutions, using basic troubleshooting skills, and efficiently handling interruptions and functions with changing environments or circumstances. Maintains a safe environment. Wears appropriate personal protective equipment as designated by lab area. Reports spills and hazardous situations immediately and acts appropriately. Follows established guidelines for disclosure of patient information. Assists in process development and improvement within the department including participating in quality assurance, continuing education programs, department meetings, and special projects. Demonstrates the initiative and ability to provide feedback that is useful and assists in individual improvement. Assist with training and competency of employees, students, fellows, rotators, etc. Education Requirement: Bachelor's Degree in medical laboratory science; or a chemical, physical, or biological science from an accredited institution, required. Licensure Requirement: (not specified) Certifications: American Society of Clinical Pathology (ASCP) certification, preferred. Skills: Organizational and communication skills, attention to detail, and computer skills. Demonstrates discipline-specific technical skills. Maintain and foster interpersonal relationships with internal and external customers. Demonstrated ability to work efficiently and independently promoting a team environment. Experience: (not specified) Physical Requirements: OCCASIONALLY: Bend/twist, Climb stairs/ladder, Fume /Gases /Vapors, Lifting / Carrying: 11-20 lbs, Lifting / Carrying: 21-40 lbs, Loud Noises, Pushing / Pulling: 0-25 lbs, Reaching above shoulder, Squat/kneel FREQUENTLY: Chemicals/Medications, Computer skills, Hand use: grasping, gripping, turning, Machinery, Repetitive hand/arm use, Walking CONTINUOUSLY: Audible speech, Biohazard waste, Blood and/or Bodily Fluids, Color vision, Communicable Diseases and/or Pathogens, Decision Making, Depth perception, Flexing/extending of neck, Hearing acuity, Interpreting Data, Lifting / Carrying: 0-10 lbs, Peripheral vision, Problem solving, Seeing - Far/near, Sitting, Standing Additional Physical Requirements performed but not listed above: (not specified) "The above list of duties is intended to describe the general nature and level of work performed by individuals assigned to this classification. It is not to be construed as an exhaustive list of duties performed by the individuals so classified, nor is it intended to limit or modify the right of any supervisor to assign, direct, and control the work of employees under their supervision. EOE M/F/Disability/Vet"

Temp QC Analyst-EM The QC Microbiology Analyst will be responsible for performing functions including environmental monitoring, utilities monitoring, and testing in a facility that manufactures sterile products and tablets in a GMP environment. REPSONSIBILITIES * Perform environmental monitoring in aseptic, classified, and controlled areas (routine, batch, quarterly EM). Direct support of the manufacturing schedule will be required, which may include over time, weekend or shift work, and holidays * Perform utilities monitoring (WFI, CLST, PW, RO, CAIR, NIT, PWTR) and testing (Endotoxin, TOC, Conductivity, Nitrates, Bioburden) * Enumerate organisms on cultured media for environmental monitoring and utility samples. * Review of routine paperwork * Perform basic lab tasks such as hood cleans, autoclave, dry heat oven, lab cleans etc. QUALIFICATIONS * Ability to work hard and contribute to an enjoyable working environment * Ability to work safely; seek out and encourage safe practices Gowning in an aseptic environment * Self-starter that takes initiative to perform work with minimal supervision * Maintain documentation in accordance with GMP including timely recording of information * Ability to cope with a rapidly changing work environment * Maintains a clean, organized lab environment * Commitment to teamwork * Willingness to learn new things * Commitment to continuous improvement in all areas * Effective communication with co-workers and supervisors * Pays attention to detail and ensures high quality work EDUCATION AND EXPERIENCE EDUCATION: High School diploma, Associate or Bachelor Degree in a biological science. EXPERIENCE: High School diploma with some experience in a GMP lab environment or Bachelor or Associate Degree in a biological science. Some college education may be substituted with additional years of relevant work experience. WORKING CONDITIONS * The successful employee will have the ability to function in a microbiological laboratory and manufacturing environment. The employee should have no inhibitions regarding safely handling microorganisms present in the laboratory and no health conditions/allergies that would prevent them from doing so or conditions which would prevent them from aseptically gowning. * Aseptic gowning must be able to be maintained including an annual requalification. * Employee must be able to pass a vision exam prior to employment and annually thereafter. * The employee will be required to participate in an on call schedule for various shift, holiday, or weekend work as needed. PHYSICAL REQUIREMENTS * Prolonged periods of sitting or standing. * Occasional periods of repetitive motion * Walking, lifting, pushing and pulling carts, reaching, climbing, and bending may all be required. * Steel toe shoes, scrubs, safety glasses, and other PPE equipment must be worn based on job being performed. * Makeup and Jewelry will not be permitted for work in classified areas or other areas as necessary

GENERAL DESCRIPTION: The position requires the individual to perform routine/non-routine physical, chemical, and in-vitro assays of clinical, commercial, process and cleaning validation samples, and process development samples to support Manufacturing. Performs physical and/or chemical analyses of product to ensure stability. Participates in the preparation of investigations, summaries and reports. Reviews data obtained for compliance to specifications and reports abnormalities. Revises and updates standard operating procedures as needed. May perform special projects on analytical and instrument problem solving. KEY DUTIES: * Perform and record analyses as assigned on a daily basis. * Adhere to cGMP's in all work practices. * Assist in maintaining a clean, safe workplace on a daily basis. * Review peer's work as needed. * Review and revise test methods. * Write and disseminate technical data summaries and reports as needed. * Research and recommend purchase of capital equipment as needed. * Purchase laboratory supplies as needed. * Coordinate sending samples and receiving data from contract laboratories as needed. * Train other colleagues in methods and procedures. * Proactively assist other team members. SKILLS/ABILITIES: * Ability to perform routine analysis, such as wet chemistry and operate basic laboratory equipment. * Understands paperwork review process. * Ability to follow written procedures and exhibit excellent documentation practices. * Basic laboratory knowledge and skills PERSONAL ATTRIBUTES: * Proactively achieves results for the best of the organization. * Willingness to learn new things. * Ability to function in a small company atmosphere. * Ability to cope with a rapidly changing work environment. * Commitment to teamwork. * Commitment to continuous improvement in all areas. * Ability to focus attention to details and ensure high quality work. * Ability to work safely; seek out and encourage safe practices EDUCATION AND EXPERIENCE: * Bachelors Degree in Chemistry with 0-2 years of laboratory experience. Other fields of specialty in Sciences are also acceptable provided sufficient chemistry coursework is completed.

About Abeona 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 Quality Control Analyst II performs routine laboratory activities in support of Good Manufacturing Practices (GMP) testing for Quality Control (QC). Testing includes qPCR, immunoassays and cell culture-based potency assays. Supports the authorship and revision of GMP documentation. Interacts with employees internal and external to Quality Control. This position will work from 4:00 PM to 12:00 AM, Monday to Friday. Training will be on first shift for four to six months (subject to change based on company need). Essential Duties and Responsibilities * Performs other duties as assigned by management. * Works on QC tasks of diverse scope, requiring basic knowledge of laboratory concepts. * Train new employees on Quality Control process flows and testing methods. * Author and revise existing Standard Operating Procedures (SOPs), testing forms and product specifications (SPCs). * Perform advanced cell culture techniques such as seeding culture dishes, transductions, and immunostaining according to approved test methods. * Completes laboratory work with precision and maintains hardcopy paperwork and electronic data in an organized manner, in compliance with company documentation practices (GDP). * Provides input to improving QC systems and procedures to improve GMP compliance. * Proactively communicates laboratory issues to supervisor or manager. * Supports laboratory investigations related to test failures, discrepancies and deviations. * Helps maintain the laboratories in a GMP compliant state, including participating in cleaning, instrument routine and preventative maintenance, logbook use, etc. Qualifications * BS in biochemistry, biology, microbiology, molecular biology or other relevant discipline with 3 to 5 years of relevant experience. * Experience and knowledge in the pharmaceutical and/or biotech industry within a GMP and/or GLP environments preferred. * Experience in cell culture, immunostaining, and drug product potency testing preferred. * Experience with DEV, CAPA and CR management preferred. * Understanding of basic scientific concepts in one or more areas above. * Experience with relevant analytical lab equipment and computers preferred. * Good mathematical and organizational skills * Ability to interact constructively with co-workers to solve problems and complete tasks * Some weekend work or late nights may be required periodically. 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. 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 * Annual Compensation: $68,000 - $82,000 (includes shift differential) 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.

Job Description About Abeona 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 Quality Control Analyst II performs routine laboratory activities in support of Good Manufacturing Practices (GMP) testing for Quality Control (QC). Testing includes qPCR, immunoassays and cell culture-based potency assays. Supports the authorship and revision of GMP documentation. Interacts with employees internal and external to Quality Control. This position will work from 4:00 PM to 12:00 AM, Monday to Friday. Training will be on first shift for four to six months (subject to change based on company need). Essential Duties and Responsibilities Performs other duties as assigned by management. Works on QC tasks of diverse scope, requiring basic knowledge of laboratory concepts. Train new employees on Quality Control process flows and testing methods. Author and revise existing Standard Operating Procedures (SOPs), testing forms and product specifications (SPCs). Perform advanced cell culture techniques such as seeding culture dishes, transductions, and immunostaining according to approved test methods. Completes laboratory work with precision and maintains hardcopy paperwork and electronic data in an organized manner, in compliance with company documentation practices (GDP). Provides input to improving QC systems and procedures to improve GMP compliance. Proactively communicates laboratory issues to supervisor or manager. Supports laboratory investigations related to test failures, discrepancies and deviations. Helps maintain the laboratories in a GMP compliant state, including participating in cleaning, instrument routine and preventative maintenance, logbook use, etc. Qualifications BS in biochemistry, biology, microbiology, molecular biology or other relevant discipline with 3 to 5 years of relevant experience. Experience and knowledge in the pharmaceutical and/or biotech industry within a GMP and/or GLP environments preferred. Experience in cell culture, immunostaining, and drug product potency testing preferred. Experience with DEV, CAPA and CR management preferred. Understanding of basic scientific concepts in one or more areas above. Experience with relevant analytical lab equipment and computers preferred. Good mathematical and organizational skills Ability to interact constructively with co-workers to solve problems and complete tasks Some weekend work or late nights may be required periodically. 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. 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 Annual Compensation: $68,000 - $82,000 (includes shift differential) 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.

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 QC Laboratory Specialist is responsible for assisting in administration of the quality functions at a site to assure adherence to ISO 9001, ISO 13485, MDSAP, FDA 21 CFR Part 820/211, EU MDR and other applicable regulatory standards. This position is responsible for performing quality inspection in accordance with the requirements for ISO, FDA QSR, and STERIS policies. This would include but is not limited to testing raw material, in-process, and finished goods using the various analytical instrumentation (i.e. HPLC, GC) and with supervision perform failure investigation. This is a second shift position. Will train Monday - Friday 2:00pm-10:30pm. Will move to Monday - Friday 4:00pm-12:30am when training is complete. What You'll Do as a Quality Control Lab Specialist Decontaminates, cleans, and sterilizes glassware and other containers. Monitors and maintains laboratory equipment including calibration. Prepares media and reagents. Performs routine product and raw material testing of samples. Performs product and raw material testing of samples. Prepares reagents, standard solutions, equipment for use, etc. Recognizes and communicates unexpected results in a timely manner and completes Out of Specification forms (OOS), Non-conformance Reports (NCR) and Incoming Rejection Forms (IRs) for nonconforming or rejected materials. The Experience, Skills and Abilities Needed Required: * Associate degree * Minimum four (4) years experience relevant lab testing in a regulated environment (i.e. FDA/ISO 13485). Will accept less years of experience and lab testing in an academic setting with Bachelor degree. What STERIS Offers We value our employees and are committed to providing a comprehensive benefits package that supports your health, well-being and financial future. Here is a brief overview of what we offer: * Market Competitive Pay * Extensive Paid Time Off and (9) added Holidays * Excellent Healthcare, Dental and Vision Benefits * Long/Short Term Disability Coverage * 401(k) with a company match * Maternity and Paternity Leave * Additional add-on benefits/discounts for programs such as Pet Insurance * Tuition Reimbursement and continued education programs * Excellent opportunities for advancement in a stable long-term career #LI-KL1 Pay range for this opportunity is $44,412.50 - $54,862.50. This position is eligible for bonus participation. 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.

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 QC Laboratory Specialist is responsible for assisting in administration of the quality functions at a site to assure adherence to ISO 9001, ISO 13485, MDSAP, FDA 21 CFR Part 820/211, EU MDR and other applicable regulatory standards. This position is responsible for performing quality inspection in accordance with the requirements for ISO, FDA QSR, and STERIS policies. This would include but is not limited to testing raw material, in-process, and finished goods using the various analytical instrumentation (i.e. HPLC, GC) and with supervision perform failure investigation. This is a second shift position. Will train Monday - Friday 2:00pm-10:30pm. Will move to Monday - Friday 4:00pm-12:30am when training is complete. What You'll Do as a Quality Control Lab Specialist Decontaminates, cleans, and sterilizes glassware and other containers. Monitors and maintains laboratory equipment including calibration. Prepares media and reagents. Performs routine product and raw material testing of samples. Performs product and raw material testing of samples. Prepares reagents, standard solutions, equipment for use, etc. Recognizes and communicates unexpected results in a timely manner and completes Out of Specification forms (OOS), Non-conformance Reports (NCR) and Incoming Rejection Forms (IRs) for nonconforming or rejected materials. The Experience, Skills and Abilities Needed Required: Associate degree Minimum four (4) years experience relevant lab testing in a regulated environment (i.e. FDA/ISO 13485). Will accept less years of experience and lab testing in an academic setting with Bachelor degree. What STERIS Offers We value our employees and are committed to providing a comprehensive benefits package that supports your health, well-being and financial future. Here is a brief overview of what we offer: • Market Competitive Pay • Extensive Paid Time Off and (9) added Holidays • Excellent Healthcare, Dental and Vision Benefits • Long/Short Term Disability Coverage • 401(k) with a company match • Maternity and Paternity Leave • Additional add-on benefits/discounts for programs such as Pet Insurance • Tuition Reimbursement and continued education programs • Excellent opportunities for advancement in a stable long-term career #LI-KL1 Pay range for this opportunity is $44,412.50 - $54,862.50. This position is eligible for bonus participation. 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.

Axogen is committed to building and maintaining a strong and gratifying company culture that fosters professional growth. Our hands-on and personal approach makes transitioning to a new job a seamless and enjoyable process. Most benefits are effective on day one! Axogen is an equal opportunity employer and does not discriminate against applicants on the basis of race, color, creed, religion, ancestry, age, sex, marital status, national origin, disability or veteran status. Why you'll love working at Axogen: Friendly, open, and fun team culture that values unique perspectives Company-wide dedication to profoundly impacting patients' lives Comprehensive, high-quality benefits package effective on date of hire Educational assistance available for all employees Matching 401(k) retirement plan Paid holidays, including floating holidays, to be used at your discretion Employee Stock Purchase Plan Referral incentive program Axogen Mission and Business Purpose Our business purpose is to restore health and improve quality of life by making restoration of peripheral nerve function an expected standard of care. We aim to lead the markets we serve by always requiring the solutions we offer patients and caregivers provide an improved benefit-to-risk profile as compared to existing standards of care. To ensure we deliver improved benefit-to-risk solutions, we will guide and expect the market and design requirement specifications underlying our engineering, business development, and clinical research activities, objectively target advancements in standards of care. Job Summary of the Sr. Scientist, Quality Control The Quality Control Sr. Scientist provides test method and qualification support along with implementation of new processes, instrumentation, cost savings, and continuous improvements. The position will support the required action steps and process improvements to meet Biologics requirements. Position will ensure QC lab complies with applicable standards and regulations and partner with various APC and/or corporate departments to complete required testing and documentation. Requirements of the Sr. Scientist, Quality Control Bachelor's degree in chemistry/biology, or closely related field 5+ years' experience in Quality Control laboratory, R&D Laboratory, or Quality Engineering preferably in a Biologics or Pharmaceutical related field. Six Sigma Green/Black Belt preferred Understanding of quality control instrumentation, troubleshooting, and testing methods including data integrity and qualification requirements. Experience leading 5S and stability programs for the lab Leadership skills to support the analytical team (encompassing ELISA, pH, osmolality, KF, UV assay, eventually LC) Problem solving using root cause methodologies including lean principles. Applying statistics and software in data analysis (example Minitab) Quality system regulations and requirements (examples 21 CFR part 600, 21 CFR Part 1271, 21 CFR Part 210/211) Responsibilities of the Sr. Scientist, Quality Control The specific duties of the Sr. Scientist, Quality Control include but are not limited to: Drive completion of OOS investigations and deviations for QC and work with QS to improve investigation module and reports related to all testing completed at APC or contract labs. Partner with Corporate Quality as required. Develop protocols for projects such as method improvements, oversee execution of the protocols, author final reports and manage approval and implementation. Partner with QC Lab Management on ongoing and new process improvements, efficiency improvements, and cross-training. This includes any method validation addendums or improvements. Direct the completion of Qualification and Re-Qualification requirements for QC Lab Instrumentation and new equipment. Contribute to validation planning for new and existing processes, instrumentation, or methods. Manage Commercial stability studies and coordination of sample testing and reports in partnership with QC Manager. Confer with external and internal departments (example Operations, Corporate Quality, Engineering, Regulatory, Quality Assurance, Quality Systems) concerning various projects and actions required. Lead and participate in BLA support including PAI action steps, audit actions, document/procedural updates, MOC creation/execution, CAPAs. Define and implement automation and new capital projects to optimize QC Lab Operations. Ensures that required testing methods are in place for all testing required for Tissue and Biologics. Prepares reports and presentations by collecting, analyzing, and summarizing data, making recommendations. Provide statistical data support for various Lean projects within QC. Develop any Project Charters required for Lab Improvement/cost savings projects. Lead Quality Control issue resolution by applying root cause methodologies. Participate in FDA inspections and internal audits. Deploying proactive quality controls for consistent and predictable quality outcomes. Establish and track metrics for monitoring laboratory effectiveness. Report to management on quality issues and investigations. Provide functional support as needed for all team members. Location 913 Industrial Drive Place, Vandalia, OH 45377 #LI-AC1 Benefits/Compensation This position is eligible for an annual bonus. Benefits offered for this position include Health, Dental, Vision, Matching 401K, Paid Time Off, 9 Paid Holidays + 3 Floating Holidays, Dependent Care Flexible Spending Accounts, Medical Flexible Spending Accounts, Tuition Reimbursement, Paid Parental Leave, Paid Caregiver Leave, Basic Life Insurance, Supplemental Life Insurance, Employee Stock Purchase Plan, and Disability Insurance, as described in more detail in summary plan descriptions. Salary Range$84,190-$105,237 USD Axogen follows healthcare system guidelines with respect to credentialing, vaccinations and other employment/compliance related requirements, as well as CDC guidance. Axogen reserves the right to amend its policies from time to time in its sole discretion.

Axogen is committed to building and maintaining a strong and gratifying company culture that fosters professional growth. Our hands-on and personal approach makes transitioning to a new job a seamless and enjoyable process. Most benefits are effective on day one! Axogen is an equal opportunity employer and does not discriminate against applicants on the basis of race, color, creed, religion, ancestry, age, sex, marital status, national origin, disability or veteran status. Why you'll love working at Axogen: * Friendly, open, and fun team culture that values unique perspectives * Company-wide dedication to profoundly impacting patients' lives * Comprehensive, high-quality benefits package effective on date of hire * Educational assistance available for all employees * Matching 401(k) retirement plan * Paid holidays, including floating holidays, to be used at your discretion * Employee Stock Purchase Plan * Referral incentive program Axogen Mission and Business Purpose Our business purpose is to restore health and improve quality of life by making restoration of peripheral nerve function an expected standard of care. We aim to lead the markets we serve by always requiring the solutions we offer patients and caregivers provide an improved benefit-to-risk profile as compared to existing standards of care. To ensure we deliver improved benefit-to-risk solutions, we will guide and expect the market and design requirement specifications underlying our engineering, business development, and clinical research activities, objectively target advancements in standards of care. Job Summary of the Sr. Scientist, Quality Control The Quality Control Sr. Scientist provides test method and qualification support along with implementation of new processes, instrumentation, cost savings, and continuous improvements. The position will support the required action steps and process improvements to meet Biologics requirements. Position will ensure QC lab complies with applicable standards and regulations and partner with various APC and/or corporate departments to complete required testing and documentation. Requirements of the Sr. Scientist, Quality Control * Bachelor's degree in chemistry/biology, or closely related field * 5+ years' experience in Quality Control laboratory, R&D Laboratory, or Quality Engineering preferably in a Biologics or Pharmaceutical related field. * Six Sigma Green/Black Belt preferred * Understanding of quality control instrumentation, troubleshooting, and testing methods including data integrity and qualification requirements. * Experience leading 5S and stability programs for the lab * Leadership skills to support the analytical team (encompassing ELISA, pH, osmolality, KF, UV assay, eventually LC) * Problem solving using root cause methodologies including lean principles. * Applying statistics and software in data analysis (example Minitab) * Quality system regulations and requirements (examples 21 CFR part 600, 21 CFR Part 1271, 21 CFR Part 210/211) Responsibilities of the Sr. Scientist, Quality Control The specific duties of the Sr. Scientist, Quality Control include but are not limited to: * Drive completion of OOS investigations and deviations for QC and work with QS to improve investigation module and reports related to all testing completed at APC or contract labs. Partner with Corporate Quality as required. * Develop protocols for projects such as method improvements, oversee execution of the protocols, author final reports and manage approval and implementation. * Partner with QC Lab Management on ongoing and new process improvements, efficiency improvements, and cross-training. This includes any method validation addendums or improvements. * Direct the completion of Qualification and Re-Qualification requirements for QC Lab Instrumentation and new equipment. Contribute to validation planning for new and existing processes, instrumentation, or methods. * Manage Commercial stability studies and coordination of sample testing and reports in partnership with QC Manager. * Confer with external and internal departments (example Operations, Corporate Quality, Engineering, Regulatory, Quality Assurance, Quality Systems) concerning various projects and actions required. * Lead and participate in BLA support including PAI action steps, audit actions, document/procedural updates, MOC creation/execution, CAPAs. * Define and implement automation and new capital projects to optimize QC Lab Operations. Ensures that required testing methods are in place for all testing required for Tissue and Biologics. * Prepares reports and presentations by collecting, analyzing, and summarizing data, making recommendations. * Provide statistical data support for various Lean projects within QC. Develop any Project Charters required for Lab Improvement/cost savings projects. * Lead Quality Control issue resolution by applying root cause methodologies. * Participate in FDA inspections and internal audits. * Deploying proactive quality controls for consistent and predictable quality outcomes. * Establish and track metrics for monitoring laboratory effectiveness. * Report to management on quality issues and investigations. * Provide functional support as needed for all team members. Location 913 Industrial Drive Place, Vandalia, OH 45377 #LI-AC1 Benefits/Compensation This position is eligible for an annual bonus. Benefits offered for this position include Health, Dental, Vision, Matching 401K, Paid Time Off, 9 Paid Holidays + 3 Floating Holidays, Dependent Care Flexible Spending Accounts, Medical Flexible Spending Accounts, Tuition Reimbursement, Paid Parental Leave, Paid Caregiver Leave, Basic Life Insurance, Supplemental Life Insurance, Employee Stock Purchase Plan, and Disability Insurance, as described in more detail in summary plan descriptions. Salary Range $84,190-$105,237 USD Axogen follows healthcare system guidelines with respect to credentialing, vaccinations and other employment/compliance related requirements, as well as CDC guidance. Axogen reserves the right to amend its policies from time to time in its sole discretion.

This role is eligible for up to a $5,000 sign-on bonus Join the Cleveland Clinic team, where you will work alongside passionate and dedicated caregivers, receive endless support and appreciation, and build a rewarding career with one of the most respected healthcare organizations in the world. A caregiver in this position performs and interprets tests at all complexity levels. This caregiver demonstrates an understanding of the theory and scientific principles of laboratory testing, as well as the technical, procedural and problem-solving aspects. A caregiver in this role maintains a questioning attitude, searching to find results to best determine patient care. This is a rewarding opportunity for those looking to make an impact in patient care at one of the world's top-ranked healthcare organizations. We will hire our clinical laboratory testing personnel in three different job titles, based on educational background: * Medical Technologist * Med Lab Technician * Lab Technician The caregiver in this role works evenings from, 3:00pm-11:30pm. A caregiver who excels in this role, will: * Follow laboratory procedures for specimen handling and processing, test analyses, report and main records of patient test results. * Maintain regulatory knowledge and awareness as it pertains to specific job duties. * Adhere to the laboratory's quality control policies, document all quality control activities, instrument and procedural calibrations and maintenance performed. * Assume responsibility for and take action regarding any quality control or quality assurance issues as it pertains to specific job duties. * Maintain instruments and equipment in accordance with manufacturer's specifications. * Assume responsibility for good documentation practices and maintain clear and legible records. * Perform proficiency testing in compliance with Clinical Laboratory Improvement Amendments (CLIA) regulations i.e. analyze proficiency survey sample in the same manner as a patient specimens, no communication with other CLIA laboratories, complete record retention and accurate documentation and result reporting. * Assume responsibility for participation in continuing education, professional development and required annual competency assessment. * Follow the laboratory's established policies and procedures whenever test systems are not within the laboratory's established acceptable levels of performance. * Identify problems that may adversely affect test performance or reporting of test results and either must correct the problems or immediately notify the General Supervisor, Technical Supervisor, Clinical Consultant, or Laboratory Director. Minimum qualifications for the ideal caregiver include: * Associate degree in a laboratory science, or medical laboratory technology from an accredited institution * OR Bachelor's degree in a chemical, physical, biological or clinical laboratory science or medical technology from a four-year college or university * OR meets the CLIA qualifications for high complexity testing personnel grandfathering clauses. * Education outside of the United States requires diploma/transcripts translated into English and proof of foreign equivalency from an HHS approved agency or nationally recognized organization such as NACES (National Association Credential Evaluation Services, Inc.) or AICE (Association of International Credential Evaluators, Inc.) Preferred qualifications for the ideal caregiver include: * Certification as a Medical Technologist (MT, MLT or MLS) or certification eligible, from the American Society of Clinical Pathology (ASCP) or American Medical Technologists (AMT) * The compensation range provided corresponds to the Medical Technologist/MLT/Lab Technician position. Individual pay rates may vary depending on licensure level and relevant experience. * Physical Requirements: * Physical demands include: Visual acuity to study specimens under a microscope. * The ability to distinguish colors. * Fine motor skills and manual dexterity to handle specimens and lab equipment required to process specimens and repair equipment. * May be required to stand for long periods of time. * Light lifting may be required. * May be exposed to hazardous chemicals, biohazards, radioactive materials, etc. Personal Protective Equipment: * Follows standard precautions using personal protective equipment as required. Pay Range Minimum hourly: $30.00 Maximum hourly: $41.65 The pay range displayed on this job posting reflects the anticipated range for new hires. A successful candidate's actual compensation will be determined after taking factors into consideration such as the candidate's work history, experience, skill set and education. The pay range displayed does not include any applicable pay practices (e.g., shift differentials, overtime, etc.). The pay range does not include the value of Cleveland Clinic's benefits package (e.g., healthcare, dental and vision benefits, retirement savings account contributions, etc.).

Requirements ESSENTIAL DUTIES AND RESPONSIBILITIES Support R&D programs by performing broad spectrum V&V activities. Responsible for routine and administrative tasks. Responsible for maintaining a clean and safe environment. Responsible to project teams as a subject matter expert in electro-mechanical verification and validation of medical devices. Lead communication and provide issue escalation support to project teams. Responsible for conducting physical, electrical and functional evaluations of products. Develop detailed test plans for devices under test. Collection of complex data streams using standard and custom instrumentation. Data analysis and presentation using spreadsheets, programming, and statistical software. Research literature to justify test parameters and evaluate designs. Author test reports in compliance with company standards and procedures. Implement established and new processes and procedures under supervision. Coordinate with contract test labs for test scheduling, methods, acceptance criteria, results analyses and reporting. Attend offsite testing to witness and assist. Responsible for developing new test methodologies to best verify and validate both on-market products and R&D prototypes. Regularly troubleshoot, diagnose, and repair existing test equipment. Design and modify fixtures to aid in testing. Work with engineering, quality and regulatory to ensure products maintain certification to applicable standards. Ability to quickly gain an understanding of these standards. Read and analyze engineering drawings, interpret professional journals, technical procedures, and government standards and regulations. Exercise judgment within defined processes and procedures on moderately complex issues. Thorough understanding of processes and procedures within job function and working knowledge across other functions. Provide verbal and written communications subject to peer and management review. QUALIFICATIONS To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Basic Competency with Microsoft Office Applications and CAD modeling/design capabilities (mechanical and electrical). Experience with SolidWorks and Altium as well as other technical software tools is a plus. Proficiency, hands-on experience and trouble-shooting skills with equipment pertinent to job function (i.e. electro-mechanical systems, computer systems, instrumentation, various testing equipment, PLCs, data acquisition systems, hand and power tools, machining equipment, etc.). Mechatronics and/or electro-mechanical test lab experience is a plus. Knowledge and/or experience with machining, metal working and fabrication is a plus. Enjoy a shop/lab setting requiring hands-on functions. Track record of test activities accountable to business or customers for program success is a plus. Exposure to and/or basic engineering understanding of design principles related to mechanical and electrical assemblies, electro-mechanical/hydraulic devices, motors, control systems, test equipment, data collection, instrumentation and calibration. Exposure and/or basic understanding of medical devices is a plus. TRAINING REQUIREMENTS FERNO Quality Management System (QMS) training applicable to position OSHA training EDUCATION and/or EXPERIENCE Associate's degree (A.A.) in Mechanical Engineering Technology, Mechatronics or equivalent from a two-year or technical school or two plus years related experience. Equivalent combination of education and experience considered. COMMUNICATION SKILLS Ability to read, analyze and interpret engineering drawings, general business periodicals, professional journals, technical procedures and government regulations. Ability to write technical documentation, procedural manuals and business correspondence. Ability to effectively present information and respond to questions from groups, managers, clients, and customers. MATHEMATICAL SKILLS Ability to work with mathematical concepts, fundamentals of plane and solid geometry and trigonometry. Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations. REASONING ABILITY Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagrammatic, or scheduled formats. 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. Manual labor will constitute up to 50% of role. This position requires the employee to move steel, aluminum, device components, etc., from tables and processing equipment. While performing the duties of this job, the employee is regularly required to stand; use hands to finger, handle, or feel; and reach with hands and arms. The employee is occasionally required to walk and stoop, kneel, crouch, or crawl. The employee must regularly lift and/or move up to 50 pounds and occasionally lift and/or move up to 100 pounds. Specific vision abilities required by this job include close vision, depth perception, and ability to adjust focus. WORK ENVIRONMENT The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The noise level in the work area may be loud. Use of eye, hearing and other personal protective equipment as required. Ferno is an equal opportunity employer and that all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran or disability status.

About this opportunity : The QC Microbiology Team Lead oversees daily operations within the QC Microbiology laboratory, ensuring all activities are executed in compliance with cGMP and company procedures. This role is responsible for scheduling and coordinating microbiological testing activities, maintaining training and quality documentation, and supporting contract laboratory oversight. Key Responsibilities: Oversee daily operations of the QC Microbiology laboratory, including scheduling of routine testing and coordination of personnel tasks. Review and approve microbiological assays, data packages, and investigations in accordance with SOPs and regulatory standards. Schedule and track training records to maintain compliance and team readiness. Coordinate with contract laboratories for sample pickup, material drop-off, courier services, and testing oversight. Write, revise, and approve laboratory documents and standard operating procedures (SOPs). Manage laboratory inventory, approve purchase requests, and maintain adequate supply levels to support operations. Lead and approve quality investigations, including deviations, change controls, and CAPAs related to microbiological systems or testing. Serve as a technical SME for microbiological assays, instruments, and environmental monitoring processes. Oversee QC sampling and testing of water systems and environmental monitoring programs, including work performed by contract laboratories. Monitor and trend environmental data per established procedures; author and close alert and action reports within defined timelines. Partner with Manufacturing, QA, and Facilities on microbial control initiatives, trending discussions, and contamination prevention activities. Lead and support complex investigations and root cause analyses, ensuring robust corrective and preventive actions. Mentor and train junior microbiology staff, providing technical guidance and developing analytical and GMP understanding. Assist in internal and external audits, including those of contract laboratories, to confirm compliance with company and regulatory requirements. Support additional projects, risk assessments, and departmental initiatives as assigned. Required Skills/Abilities: Bachelor's degree in Microbiology, Biology, Chemistry, or related scientific discipline, or equivalent combination of education and experience. Minimum 6 years of experience in a microbiological or quality control laboratory environment. Prefer at least 2 years of direct supervisory experience. Strong technical expertise in: Endotoxin testing Water bioburden testing TOC and conductivity analysis Media management and growth promotion testing Gram staining and microbial isolation techniques Sterility testing methods Plate enumeration and environmental monitoring in classified cleanrooms (ISO 5-9, CNC areas) Non-viable and viable air, surface, and swab sampling Water chemistry testing Microbial identification by phenotypic or genetic methods Growth Promotion Experience leading or coordinating work with contract laboratories. Demonstrated experience conducting contamination investigations and microbial risk assessments. Comprehensive understanding of cGMPs, USP chapters (e.g., 61, 62, 1116, 1117), and regulatory expectations for microbiological control. Strong organizational, analytical, and data management abilities. Excellent communication and collaboration skills to interface cross-functionally with internal and external stakeholders. The annualized salary range for this position is $88,800.00 - $108,600.00.

Department: Lab Processing Weekly Hours: 36 Status: Full time Shift: Days (United States of America) As a Pre-Analytic Technician, you will have a direct impact on patient outcomes by conducting vital tests and analyses helping in the diagnosis and treatment of medical conditions. You will make sure patients receive accurate and timely test results. In this role, you must know combinations of tests and the acceptable minimum volumes. You must also be familiar with test synonyms and abbreviations and cross-referencing tests to specimen types. You will complete and log routine maintenance on lab equipment and workstations and ensuring work areas are clean and stocked. The above summary of accountabilities is intended to describe the general nature and level of work performed in this role. It should not be considered exhaustive. REQUIREMENTS * High school diploma or equivalent PREFERRED REQUIREMENTS * Associates or Bachelor's degree in a science related field ProMedica is a mission-driven, not-for-profit health care organization headquartered in Toledo, Ohio. It serves communities across nine states and provides a range of services, including acute and ambulatory care, a dental plan, and academic business lines. ProMedica owns and operates 10 hospitals and has an affiliated interest in one additional hospital. The organization employs over 1,300 health care providers through ProMedica Physicians and has more than 2,300 physicians and advanced practice providers with privileges. Committed to its mission of improving health and well-being, ProMedica has received national recognition for its clinical excellence and its initiatives to address social determinants of health. For more information about ProMedica, please visit promedica.org/aboutus. Benefits: We provide flexible benefits that include compensation and programs to help you take care of your family, your finances and your personal well-being. It's what makes us one of the best places to work, and helps our employees live and work to their fullest potential. Qualified applicants will receive consideration for employment without regard to race, color, national origin, ancestry, religion, sex/gender (including pregnancy), sexual orientation, gender identity or gender expression, age, physical or mental disability, military or protected veteran status, citizenship, familial or marital status, genetics, or any other legally protected category. In compliance with the Americans with Disabilities Act Amendment Act (ADAAA), if you have a disability and would like to request an accommodation in order to apply for a job with ProMedica, please contact ************************ Equal Opportunity Employer/Drug-Free Workplace

Department: Lab Processing Weekly Hours: 24 Status: Part time Shift: Evenings (United States of America) As a Pre-Analytic Technician, you will have a direct impact on patient outcomes by conducting vital tests and analyses helping in the diagnosis and treatment of medical conditions. You will make sure patients receive accurate and timely test results. In this role, you must know combinations of tests and the acceptable minimum volumes. You must also be familiar with test synonyms and abbreviations and cross-referencing tests to specimen types. You will complete and log routine maintenance on lab equipment and workstations and ensuring work areas are clean and stocked. The above summary of accountabilities is intended to describe the general nature and level of work performed in this role. It should not be considered exhaustive. REQUIREMENTS * High school diploma or equivalent PREFERRED REQUIREMENTS * Associates or Bachelor's degree in a science related field ProMedica is a mission-driven, not-for-profit health care organization headquartered in Toledo, Ohio. It serves communities across nine states and provides a range of services, including acute and ambulatory care, a dental plan, and academic business lines. ProMedica owns and operates 10 hospitals and has an affiliated interest in one additional hospital. The organization employs over 1,300 health care providers through ProMedica Physicians and has more than 2,300 physicians and advanced practice providers with privileges. Committed to its mission of improving health and well-being, ProMedica has received national recognition for its clinical excellence and its initiatives to address social determinants of health. For more information about ProMedica, please visit promedica.org/aboutus. Benefits: We provide flexible benefits that include compensation and programs to help you take care of your family, your finances and your personal well-being. It's what makes us one of the best places to work, and helps our employees live and work to their fullest potential. Qualified applicants will receive consideration for employment without regard to race, color, national origin, ancestry, religion, sex/gender (including pregnancy), sexual orientation, gender identity or gender expression, age, physical or mental disability, military or protected veteran status, citizenship, familial or marital status, genetics, or any other legally protected category. In compliance with the Americans with Disabilities Act Amendment Act (ADAAA), if you have a disability and would like to request an accommodation in order to apply for a job with ProMedica, please contact ************************ Equal Opportunity Employer/Drug-Free Workplace

**Department:** Lab Processing **Weekly Hours:** 36 **Status:** Full time **Shift:** Days (United States of America) As a Pre-Analytic Technician, you will have a direct impact on patient outcomes by conducting vital tests and analyses helping in the diagnosis and treatment of medical conditions. You will make sure patients receive accurate and timely test results. In this role, you must know combinations of tests and the acceptable minimum volumes. You must also be familiar with test synonyms and abbreviations and cross-referencing tests to specimen types. You will complete and log routine maintenance on lab equipment and workstations and ensuring work areas are clean and stocked. The above summary of accountabilities is intended to describe the general nature and level of work performed in this role. It should not be considered exhaustive. REQUIREMENTS + High school diploma or equivalent PREFERRED REQUIREMENTS + Associates or Bachelor's degree in a science related field **ProMedica** is a mission-driven, not-for-profit health care organization headquartered in Toledo, Ohio. It serves communities across nine states and provides a range of services, including acute and ambulatory care, a dental plan, and academic business lines. ProMedica owns and operates 10 hospitals and has an affiliated interest in one additional hospital. The organization employs over 1,300 health care providers through ProMedica Physicians and has more than 2,300 physicians and advanced practice providers with privileges. Committed to its mission of improving health and well-being, ProMedica has received national recognition for its clinical excellence and its initiatives to address social determinants of health. For more information about ProMedica, please visit promedica.org/aboutus (****************************************************** . **Benefits:** We provide flexible benefits that include compensation and programs to help you take care of your family, your finances and your personal well-being. It's what makes us one of the best places to work, and helps our employees live and work to their fullest potential. Qualified applicants will receive consideration for employment without regard to race, color, national origin, ancestry, religion, sex/gender (including pregnancy), sexual orientation, gender identity or gender expression, age, physical or mental disability, military or protected veteran status, citizenship, familial or marital status, genetics, or any other legally protected category. In compliance with the Americans with Disabilities Act Amendment Act (ADAAA), if you have a disability and would like to request an accommodation in order to apply for a job with ProMedica, please contact **************************** Equal Opportunity Employer/Drug-Free Workplace

**Department:** Lab Processing **Weekly Hours:** 24 **Status:** Part time **Shift:** Evenings (United States of America) As a Pre-Analytic Technician, you will have a direct impact on patient outcomes by conducting vital tests and analyses helping in the diagnosis and treatment of medical conditions. You will make sure patients receive accurate and timely test results. In this role, you must know combinations of tests and the acceptable minimum volumes. You must also be familiar with test synonyms and abbreviations and cross-referencing tests to specimen types. You will complete and log routine maintenance on lab equipment and workstations and ensuring work areas are clean and stocked. The above summary of accountabilities is intended to describe the general nature and level of work performed in this role. It should not be considered exhaustive. REQUIREMENTS + High school diploma or equivalent PREFERRED REQUIREMENTS + Associates or Bachelor's degree in a science related field **ProMedica** is a mission-driven, not-for-profit health care organization headquartered in Toledo, Ohio. It serves communities across nine states and provides a range of services, including acute and ambulatory care, a dental plan, and academic business lines. ProMedica owns and operates 10 hospitals and has an affiliated interest in one additional hospital. The organization employs over 1,300 health care providers through ProMedica Physicians and has more than 2,300 physicians and advanced practice providers with privileges. Committed to its mission of improving health and well-being, ProMedica has received national recognition for its clinical excellence and its initiatives to address social determinants of health. For more information about ProMedica, please visit promedica.org/aboutus (****************************************************** . **Benefits:** We provide flexible benefits that include compensation and programs to help you take care of your family, your finances and your personal well-being. It's what makes us one of the best places to work, and helps our employees live and work to their fullest potential. Qualified applicants will receive consideration for employment without regard to race, color, national origin, ancestry, religion, sex/gender (including pregnancy), sexual orientation, gender identity or gender expression, age, physical or mental disability, military or protected veteran status, citizenship, familial or marital status, genetics, or any other legally protected category. In compliance with the Americans with Disabilities Act Amendment Act (ADAAA), if you have a disability and would like to request an accommodation in order to apply for a job with ProMedica, please contact **************************** Equal Opportunity Employer/Drug-Free Workplace

The Associate Director, GMP Operational Quality is an advanced technical resource in the principles and application of quality assurance and compliance. This role is responsible for primary QA oversight of commercial drug substance manufacturing performed at Vertex's external vendors as well as secondary quality support of commercial drug product manufacturing vendors. This position ensures robust sterile manufacturing controls, commercial supply continuity, support for global jurisdictional expansion, and high‑level combination product quality alignment. The incumbent will mentor team members to provide individual development in addition to efficient and valuable service to project teams. Key Duties and Responsibilities: Collaborate with internal and external business partners to resolve complex quality issues to ensure compliant solutions Oversee CMO/Vendor performance, establishment of Quality Agreements and adherence of Quality Agreement terms Enable team to achieve team goals/objectives and enable their individual career development Develop and maintain compliant quality processes to support GMP activities Oversee the QA support of Change Controls, GMP investigations and associated CAPAs. Performs review and approval of master and executed batch records to support drug substance (DS), drug product (DP), device (Autoinjector) and finished goods (FG) disposition activities Track performance metrics and report to Sr Management; develops tactics to improve performance outcomes Participate in inspection readiness activities and lead Quality development discussions as necessary during regulatory site inspections. Support review of regulatory submissions, as applicable Lead continuous improvements of department processes, realizing efficiency gains, and ensuring team continues to meet expanding business needs with lean resources. Lead and follow up on any QLT action items assigned. Identify and communicate risks and assist with risk mitigation plans as necessary Supports internal audit or external audit programs; assists in preparation of audit responses Provide comprehensive knowledge support for partner and regulatory agency audits Assist management team in budgeting and scheduling Responsible for the following activities related to people management responsibilities: Talent Acquisition/ Recruiting/Interviewing/ Selection/Onboarding Accountable to provide oversight of day to day team operations Knowledge and Skills: In-depth and specialized knowledge of both the conceptual and practical application of cGMPs in a pharmaceutical setting; in-depth knowledge of global GMP requirements and managing quality in support GMP manufacturing Demonstrated success in building high-performing teams and skilled at managing team and individual development Strong management skills with the ability to lead and motivate a team in a fast-paced environment while maintaining a high degree of quality, accuracy and timeliness Substantial background in managing complex projects/teams within stated objectives and timelines and with a strong understanding of the underlying business drivers; skilled at applying project management processes / tools to lead meetings, assist with project planning, and facilitate attainment of project objectives Ability to independently lead cross-functional teams and represent the interests, strategies and objectives of Quality unit Strong skills in mentoring staff and transferring technical knowledge to enable their capabilities and development Ability to communicate cross-functionally to a wide variety of audiences; exchanges complex concepts with the ability to influence leaders, customers, or vendors to adopt of a new point of view and/or to take action Demonstrated ability to evaluate complex quality matters and make decisions utilizing risk-based approach; identifies and leverages the appropriate expertise to implement solutions Substantial experience successfully leading event investigations, Root Cause Analysis (RCA), and CAPA Extensive exposure with multiple regulatory agencies across applicable GxPs during inspections Supstantial experience with electronic document management systems (e.g., Veeva) Education and Experience: Bachelor's degree in a scientific or allied health field (or equivalent degree) Typically requires 8+ years of work experience and 2 years of management experience, or the equivalent combination of education and experience #LI-hybrid Pay Range: $154,100 - $231,200 Disclosure Statement: The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law. At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more. Flex Designation: Hybrid-Eligible Or On-Site Eligible Flex Eligibility Status: In this Hybrid-Eligible role, you can choose to be designated as: 1. Hybrid: work remotely up to two days per week; or select 2. On-Site: work five days per week on-site with ad hoc flexibility. Note: The Flex status for this position is subject to Vertex's Policy on Flex @ Vertex Program and may be changed at any time. #LI-Hybrid Company Information Vertex is a global biotechnology company that invests in scientific innovation. Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com

Reconciliation of unposted and posted cash with the cash management tools and Epic. Along with variance reporting, G/L reconciliation and Third-Party biller support and customer service. **Essential Functions** + Evaluate payment variances in Epic WQs against payer contracts to determine if payer underpaid or overpaid, and dispositions variance based upon established protocols. + Identify trends through reporting and data analysis and leverages data to resolve errors in Epic proration rules, payer under and/or overpayment trends, opportunities in billing, and opportunities with managed care contracting efforts. + Log findings and provides feedback to Hospital Billing AR Management, Cash Management, and Managed Care leadership. + Perform root cause analysis and recommend and develop process improvement. + Serve as a liaison to internal teams to include the Epic Contract Maintenance Committee and to external payment variance vendors to leverage contract terms and mitigate revenue leakage and denials. + Help design and implement improvements to established or proposed reimbursement process flows to maximize potential revenue + Work with Managed Care to ensure knowledge and interpretation of managed care contracts are aligned with original intent of health system contracting efforts. + Work with Compliance, Finance and Government insurance follow up teams to stay abreast of legislative changes impacting revenue and driving payment variances. + Initiate contact with technical teams to work through technical builds and enhancements for the Payment Variance team. + Participate and lead special projects, as assigned. Oversee workflow implementation with internal and external partners. Compile and coordinate materials and feedback on special projects. Trains and mentors' new associates to the department. Serves as a subject matter expert and resource to answer questions within the department. **Skills** + Billing + Customer Follow-Ups + People Management + Payment Handing + Management Reporting + Managed Care + Taking Initiative + Reconciliation + Reading and EOB + Analytics **Qualifications** + High School Diploma or Equivalent, required + Three (3) years of experience in revenue cycle insurance follow up or denial management, required + Associate's degree, preferred + Three (3) years of work experience in a complex invoice/billing/reconciliation environment, preferred- Extensive knowledge of managed care contract interpretation The following states are currently paused for sourcing new candidates or for new relocation requests from current caregivers: California, Connecticut, Hawaii, Illinois, New York, Rhode Island, Vermont, Washington **"Please note that a video interview through Microsoft Teams will be required as well as potential onsite interviews and meetings."** **Physical Requirements** + Interact with others by effectively communicating, both orally and in writing. + Operate computers and other office equipment requiring the ability to move fingers and hands. + See and read computer monitors and documents. + Remain sitting or standing for extended periods of time to perform work on a computer, telephone, or other equipment. May require lifting and transporting objects and office supplies, bending, kneeling, and reaching. **Location:** Peaks Regional Office **Work City:** Broomfield **Work State:** Colorado **Scheduled Weekly Hours:** 40 The hourly range for this position is listed below. Actual hourly rate dependent upon experience. $24.00 - $36.54 We care about your well-being - mind, body, and spirit - which is why we provide our caregivers a generous benefits package that covers a wide range of programs to foster a sustainable culture of wellness that encompasses living healthy, happy, secure, connected, and engaged. Learn more about our comprehensive benefits package here (***************************************************** . Intermountain Health is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. At Intermountain Health, we use the artificial intelligence ("AI") platform, HiredScore to improve your job application experience. HiredScore helps match your skills and experiences to the best jobs for you. While HiredScore assists in reviewing applications, all final decisions are made by Intermountain personnel to ensure fairness. We protect your privacy and follow strict data protection rules. Your information is safe and used only for recruitment. Thank you for considering a career with us and experiencing our AI-enhanced recruitment process. All positions subject to close without notice.