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Quality Control Inspector jobs at Medline - 483 jobs

  • Quality Inspector, Medical Devices - Impact Patient Care

    Edwards Lifesciences Belgium 4.6company rating

    Salt Lake City, UT jobs

    A leading medical technology company in Salt Lake City is seeking a qualified candidate for quality inspection roles in medical device manufacturing. The job includes performing inspections, conducting functional tests of medical products, and ensuring compliance with safety and quality standards. An H.S. Diploma is required, along with English proficiency. Ideal candidates will demonstrate strong communication abilities and attention to detail, working within a team to support patient care and environmental safety protocols. #J-18808-Ljbffr
    $39k-46k yearly est. 2d ago
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  • First Shift Medical Device Quality Inspector

    Edwards Lifesciences Belgium 4.6company rating

    Salt Lake City, UT jobs

    A leading medical technology company is seeking a Quality Inspector in Salt Lake City. This position involves performing inspections and functional testing of medical device products, ensuring compliance with specifications. Candidates must have a high school diploma and proficient English skills. Attention to detail and ability to work independently are essential. The job includes a shift from Monday to Thursday, with a pay rate of $19.44/hr and requires COVID-19 vaccination as a condition of employment. #J-18808-Ljbffr
    $19.4 hourly 2d ago
  • Quality Systems Lead

    Alkermes 4.9company rating

    Waltham, MA jobs

    Govern owned QMS applications, including harmonization of processes across sites. Responsible for requirements authoring and ongoing maintenance by leading and facilitating meetings/workshops with Site Process Owners and Key Users (Business SMEs). Approve validation deliverables including initial implementation and operational changes. Change ownership, including initiating and managing change through completion. Maintain system in a validated state, including periodic user access review, ongoing change management, business administration, and deviations/CAPAs associated with QMS. Lead and manage user forums for ongoing requirements gathering, prioritization, and triaging of issues. Lead and manage ongoing meetings with the vendor/IT as necessary. Report status and issues to governance committees/senior leadership. Communicate milestones and planned changes to user community promoting use of QMS. Responsible for representing owned QMS applications during inspections and explaining compliance. Train management and onboard new users to the system. Ensure Periodic Reviews (PR) are conducted per required frequency and approve PR Reports. Support Quality System Vendor Audits as a Business SME. Support KPI reporting and lead commitment meetings. Manage regular system updates/releases and assess and recommend new features. Ensure key user-related documentation is maintained and kept up-to-date as new functionalities are enabled, created and/ or modified. Investigate, escalated, and resolve issues identified on system. Execute/facilitate regression testing associated with system upgrades/project implementation. Participate in user forums/industry groups to garner best practice and represent Alkermes. Identify opportunities for continuous improvement and prioritize and manage associated change to completion. Qualifications Bachelor's degree in Computer Science, Engineering, or related field and five years of experience implementing and maintaining regulated systems. Experience must include five years each of the following: project management; development of user procedures; and SaaS (Software as a Service Solution)/cloud solutions. Experience must include one year each of the following:TrackWise Digital, ComplianceWire, and Veeva; system testing in a regulated industry; quality systems processes in commercial/clinical pharma/healthcare facility; US FDA, ICH guidelines, and European regulatory requirements; GAMP; and development of CBT (computer-based training) modules. Experience may be gained concurrently. The annual base salary for this position ranges from $141,000 to $146,000. In addition, this position is eligible for an annual performance pay bonus. Exact compensation may vary based on skills, training, knowledge, and experience. Alkermes offers a competitive benefits package. Additional details can be found on our careers website:************************************* . #J-18808-Ljbffr
    $141k-146k yearly 2d ago
  • QA Radiology Technician

    NYC Health + Hospitals/Correctional Health Services 4.7company rating

    New York, NY jobs

    NYC Health + Hospitals is the largest public health care system in the nation. We are a network of 11 hospitals, trauma centers, neighborhood health centers, nursing homes, post-acute care centers, and correctional health services. We are a home care agency and a health plan, MetroPlus. Our health system provides essential services to 1.4 million New Yorkers every year in more than 70 locations across the city's five boroughs. Our diverse workforce of more than 42,000 employees are uniquely focused on empowering New Yorkers. NYC Health + Hospitals/Correctional Health Services is one of the nation's leading correctional health care systems in quality of and innovations to care, and access from pre-arraignment through compassionate release. In-jail services include medical, nursing, mental health, substance use treatment, social work, dental and vision care, discharge planning, and reentry support. In addition to providing direct patient care in the jails, CHS leverages the resources of the nation's largest municipal health care system to help discharged patients successfully return to their communities. CHS is also a pivotal partner in New York City's criminal justice reform efforts. The Quality Assurance (QA) Radiological Technologist position encompasses responsible, administrative and clinical activity of varying degrees of latitude. Clinical level judgement is needed in the daily supervision of radiological functions and patient care, and departmental projects. Responsibilities include: Review exam orders, consult with radiologist, schedule patients and arrange for transportation as indicated. Identify patient and document all information pertinent to final report in the RIS and on images (PACS). Prepare all patients (infants, children, adolescents, adults and geriatric) for radiological procedures requested by the clinician. Arrange for proper protection of patients, public and staff from infectious diseases/materials. Perform all general diagnostic imaging and routine examination in CT and Angiography. Assists in performing daily checks of radiographic imaging equipment, immobilization devices and other necessary accessories. Enters data and maintains documents and logs as required and mandated by the department QA guidelines and various regulatory agencies. Maintains adequate stocks of supplies and materials needed for use in the department. Checks equipment for defects prior for use and assures proper use of such equipment through instruction and review. Report any unexpected patient incidents in accordance with the occurrence report protocol. Maintain and exercise all mandated radiation safety regulations. Maintain basic care of all the imaging equipment. All malfunctions are to be reported to management staff whether mechanical, electrical or suspect and service request documentation completed. Maintain a clean and safe work environment for both patients and staff. Perform other duties as deemed necessary (by supervisory or administrative staff) in the event of emergencies or disasters. Continue professional growth and development of job-related skills on an ongoing basis. Participate in continuing education activities. Ensure all examinations are accessioned, documented and sent to PACS for reading. Monitor PACS and RIS incomplete worklists to ensure all exams are completed. In accordance with HIPAA (the Health Insurance Portability and Accountability Act), staff members will exercise due diligence in ensuring patient privacy and confidentiality. Identifies activities that the network has implemented to promote patient safety and takes all necessary precautions to ensure a safe environment for patients, visitors and staff. In addition to the Radiology Technologist job functions, the QA Technologists is responsible for the following: Organize and file maintenance reports for each building in regards to dentistry and radiology x-ray equipment and ensure dentistry and x-ray equipment follow the Department of Health codes, policies and procedures. Participates in quality assurance activities, including coordination, control and maintenance of technical equipment. Establish a daily/weekly/monthly quality control routine for monitoring, evaluating, and maintenance of X-ray equipment to ensure optimal performance and stability. Documenting and maintaining records for the quality control program in accordance with applicable regulations, legal requirements, accrediting agencies and recommendations from equipment manufacturers. Performs research and participates in special projects involving evaluation of equipment and delivery of service. Work with our radiologists to obtain updated documentation of primary diagnostic monitors. Distribute/collect dosimeter badges from each employee/facility that works with x-ray equipment. Recommends area assignment of personnel to coordinate activities within the department with other activities and services and represents the department in interdepartmental operations and meetings. May be assigned duties and responsibilities of X-ray Director in regards to radiology department workflow. Minimum Qualifications: Assignment Level III 1. For Supervisory Assignments: a valid license and current registration to practice Diagnostic Radiography as a Radiologic Technologist issued by the NYSDOH; and two (2) years of Radiologic Technologist experience performing duties consistent with Assignment Levels I and II, one (1) year of which must have been in a supervisory capacity. 2. For Specialized Imaging Assignments: a valid license and current registration to practice Diagnostic Radiography as a Radiologic Technologist issued by the NYSDOH; and possession of a current advanced- level certification for the performance of these procedures. NYC Health and Hospitals offers a competitive benefits package that includes: Comprehensive Health Benefits for employees hired to work 20+ hrs. per week Retirement Savings and Pension Plans Paid Holidays and Vacation in accordance with employees' Collectively bargained contracts Loan Forgiveness Programs for eligible employees College tuition discounts and professional development opportunities College Savings Program Union Benefits for eligible titles Multiple employee discounts programs Commuter Benefits Programs
    $36k-57k yearly est. 2d ago
  • Global Quality Policy & Advocacy Leader

    Gilead Sciences, Inc. 4.5company rating

    Washington, DC jobs

    A leading biopharmaceutical company is seeking a Senior Director of Quality Policy and Advocacy to lead global policy initiatives. This role requires extensive experience in Quality strategies, particularly within North American regulatory landscapes. You will be responsible for advocating Gilead's portfolio interests and engaging with stakeholders to resolve complex Quality issues. The ideal candidate will have a strong background in regulatory affairs, leadership skills, and the ability to communicate effectively with diverse audiences. This role offers a competitive salary and benefits. #J-18808-Ljbffr
    $91k-117k yearly est. 2d ago
  • Senior Product Quality Lead - CMC & Regulatory Strategy

    Gilead Sciences, Inc. 4.5company rating

    Foster City, CA jobs

    A leading biotechnology firm located in California is seeking a Director of Quality Assurance to oversee product quality and establish specifications for clinical and commercial products. The role requires extensive experience in analytical chemistry and regulatory compliance, along with strong leadership skills in a complex matrix environment. This is a full-time on-site position offering the opportunity to lead strategic quality initiatives. #J-18808-Ljbffr
    $114k-146k yearly est. 1d ago
  • Product Quality Lead

    Gilead Sciences, Inc. 4.5company rating

    Foster City, CA jobs

    The primary responsibility for this position is to establish phase appropriate product specifications for Gilead's clinical and commercial products. In addition, this position is responsible for end to end product quality strategy and serves as the QA main point of contact on the PDM Product Strategy Team(s). The position holds a scientific and technical understanding of drug development and commercialization and able to provide effective quality oversight and feedback for their assigned program(s) by liaising between the Product Strategy Team, Manufacturing, and Analytical functions, Supply Chain, RA CMC, and the wider PDM Quality organization. Job Functions Expert in analytical control systems, assuring network-wide harmonization of control systems by proactive lifecycle management, technical leadership and ownership. Provide technical oversight of product specification setting and justification based on scientific approach. Deep understanding of analytical methods (development, validation, transfer, and monitoring) and product (process development, CQA analysis, stability, comparability, etc). Ability to evaluate Global product filing strategies with core PDM Team for implementation. Provide timely support for health authority interactions on the product, authorship/review (as needed) relevant health authority information requests for in-process controls, process development (comparability), method validation, specifications, reference standard, and stability sections of regulatory submissions. Build internal knowledge and capabilities on product control strategies. Proactively share expertise with other functional groups to generate alignment and improvement opportunities. Accountable for end-to-end quality compliance of the assigned product/program, which include but not limited to providing strategic leadership and direction for quality and compliance activities and owns the overall product risk log. Serve as the primary Quality representative in the PDM meeting. Lead Product Quality Teams (PQT) supporting the product/program, and ensure visibility and communication of strategy, key project timelines and CMC milestones. Monitor and review cross-functional process and product data to identify trends to ensure significant quality and compliance risks are identified, mitigated and, if necessary, escalated in a timely manner. Review and approve the strategy for change control(s) impacting the product/program lifecycle. Provide technical oversight of Major and/or Critical Deviations, CAPAs, Biological Product Deviation and Complaints. Contribute to Review Regulatory Submissions (IND, IMPD, BLA, NDA, MAA), and assist with regulatory communications as needed (e.g. responses to agency information requests, the Notified Body Option). Provide oversight for changes to drug substance and drug product CMC details. Accountable for PAI/PLI readiness and supports Gilead PAI/PLI inspection preparation efforts and post-PAI/PLI follow up as a Subject Matter Expert with Quality representatives at CXO(s) and Gilead Sites. Support drug substance and drug product technology transfer, and new product launches. Participate in drafting commercial Annual Product Quality Review (APQR) and review/approve Gilead and CMO APQRs for commercial products. Accountable for medical device/ combination product quality compliance: engage/liaise with medical device product engineering, development, and quality teams. Facilitate Analytical Strategy (stability strategy, specifications, Critical Quality Attributes). Perform work that requires independent decision making and the exercise of independent judgment. Serve as the delegate for direct manager, as needed, for meeting and decision making. Knowledge, Experience and Skills Well verse in technical requirements for product control systems. Strong knowledge and practical experience in analytical chemistry, including separation science, wet chemistry, physicochemical characterization or related areas. Strong experience in the assessment of technical data and scientific information is required in order to provide technical reviews for documents and regulatory submissions. In-depth understanding and application of GMP principles, concepts, best practices, and standards in the US and internationally. Demonstrated ability to develop and improve complex concepts, techniques, and standards and new applications based on quality principles. In-depth knowledge in Global requirements/standards for product registration and life-cycle management of product quality. Extensive knowledge and experience in technology validation/transfer of Drug Substance and Drug Product. Skilled at managing multiple projects and timelines and to facilitate meetings. In-depth understanding and execution of Quality Risk Management. Ability to track and follow up on actions. Excellent in verbal, written and interpersonal communication skills. Ability to work in a team-oriented approach to address complex issues in a scientifically sound and compliant way. Ability to lead and influence a matrix-based cross-functional team. Critical and strategic thinking skills and ability to provide pragmatic, risk-based, and phase appropriate guidance and decision-making even when quality and compliance requirements are not well-defined. Extensive knowledge and experience in technology validation/transfer of Drug Substance and Drug Product. Basic Qualifications 12+ years of relevant experience and a Bachelor's degree in science or related fields. OR 10+ years of relevant experience and a science degree MS OR 8+ years PhD Preferred Qualifications Prior Quality leadership and technical management experience in development and/or commercial programs. 15+ years of relevant experience and a Bachelor's degree in science or related fields; or 10+ years of relevant experience and an advanced science degree such as MS, PharmD, PhD or an advanced business degree such as an MBA. Demonstrated experience and knowledge in quality assurance in a highly regulated manufacturing environment. Direct experience with regulatory health authority submissions (e.g. IND, NDA, BLA, MAA) and/or inspections. Broad experience across several including process validation, drug development experience, packaging/labeling and understanding of Parenteral, Oral Solid Dosage, and Biologics. Job Requisition ID R0047720 Full Time/Part Time Full-Time Job Level Director Remote Type Onsite Required #J-18808-Ljbffr
    $114k-146k yearly est. 1d ago
  • Global Supplier Quality Leader

    Gilead Sciences, Inc. 4.5company rating

    Foster City, CA jobs

    A leading biopharmaceutical company in California is seeking a Senior Director for Global Supplier Quality. The successful candidate will lead a team of Quality Professionals, ensuring compliance with GMP standards while managing supplier quality initiatives. This role requires extensive experience in biopharmaceutical management, exceptional leadership skills, and a strong understanding of regulatory requirements. Candidates should have a solid educational background in science and proven leadership experience in complex organizations. Competitive salary & benefits are offered. #J-18808-Ljbffr
    $114k-146k yearly est. 1d ago
  • Quality Control Inspector

    BPI Medical 4.2company rating

    Tacoma, WA jobs

    BPI Medical is growing at a remarkable rate and offers a rewarding career for a proven leader interested in making a difference every day. We embrace our entrepreneurial culture and have created a workplace where collaboration is essential, courage is rewarded, speed is expected, and agility is the norm to meet our customer's needs. Our motto is "Its gotta be right. its gotta be fast. no exceptions." We live by our values of Integrity, Quality, On-time Delivery, Collaboration, Growth Mindset and Compassion. We have a relaxed work atmosphere with an exceptional staff. We understand that continuous improvement is more than a business philosophy. It's a personal contribution to making our customers, our business, and our team members better every day. This position will engage in quality control activities designed to inspect, measure, and verify the effectiveness, and adherence to medical industry quality standards. The position is expected to work independently with the ability to exercise sound judgment, following established processes and procedures that govern quality control inspection. Conducting inspections and tests on incoming raw materials, components, and finished products to ensure they meet established quality standards and specifications. Performing visual inspections, measurements, and functional tests on medical devices to verify their compliance with applicable regulations and standards, such as ISO 13485 and FDA guidelines. Documenting inspection results and maintaining accurate records of quality control activities in accordance with regulatory requirements. Proficient in the use of mechanical inspection equipment; including micrometers, calipers, fixed gauges, optical comparator, CMM and other inspection measuring tools. Identifying and reporting non-conformities or deviations to appropriate personnel for investigation and corrective action. Participating in investigations of quality issues and working with cross-functional teams to determine root cause and implement corrective and preventive actions. Ensuring that inspection equipment and tools are calibrated and maintained in accordance with regulatory requirements and company procedures. Developing and implementing quality control procedures and work instructions to ensure consistent product quality. Collaborating with production staff and other stakeholders to address quality issues and drive continuous improvement. Participating in internal and external quality audits to ensure compliance with applicable regulations and standards. Communicating effectively with customers, suppliers, and other stakeholders on quality-related matters, including product quality, regulatory compliance, and quality system requirements. We are proud to be an Equal Opportunity Employer. BPI Medical, also known as Ben's Precision Instruments, was founded by a machinist-craftsman from Holland. Ben Overmars Sr. is both an immigrant and a worker performing fully with a disability. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, among other things, or status as a qualified individual with disability. As a federal contractor, BPI Medical is required to participate in the federal government's E-Verify program. With E-Verify we are able to confirm the employment authorization of all newly hired employees and most existing employees through an electronic database maintained by the Social Security Administration and Department of Homeland Security.
    $50k-62k yearly est. 60d+ ago
  • Quality Control Inspector - Irvine

    Applied Medical Distribution Corporation 4.4company rating

    Irvine, CA jobs

    Applied Medical is a new generation medical device company with a proven business model and commitment to innovation fueled by rapid business growth and expansion. Our company has been developing and manufacturing advanced surgical technologies for over 35 years and has earned a strong reputation for excellence in the healthcare field. Our unique business model, combined with our dedication to delivering the highest quality products, enables team members to contribute in a larger capacity than is possible in typical positions. Position Description Are you detail-oriented with a passion for maintaining the highest standards of quality in manufacturing? Join Applied Medical as a Quality Control Inspector and play a vital role in ensuring the excellence of our raw materials, components, and finished products. As part of our Quality Assurance team, you'll utilize precision measurement tools, review engineering documentation, and uphold strict compliance with industry standards. Key Responsibilities: * Conduct thorough inspection activities, including receiving, in-process, and final product verification. * Assess raw materials, components, subassemblies, and finished products for adherence to standards, guidelines, and specifications outlined in company procedures. * Interpret engineering drawings, shop order operations, and process controls to ensure accuracy in production. * Inspect products and materials following standard operating procedures and work instructions. * Utilize technical measuring devices to confirm product conformance to defined specifications. * Document and report nonconforming materials, ensuring accurate record-keeping. * Maintain detailed inspection results using data management software. Position Requirements * Forklift certified and/or willingness to learn. * 2+ years of experience working within quality management systems (ISO 9001, ISO 13485, or 21 CFR Part 820). * Ability to read, write, and communicate in English effectively. * Understanding and adherence to Applied Medical's Quality Systems and training guidelines. * Compliance with safety rules and company policies. * Ability to work Monday through Friday 8:00am - 4:30pm. Preferred * Hands-on manufacturing experience, particularly within the medical device industry. Benefits * Competitive compensation range: $18 - 23 / hour (California). * Comprehensive benefits package. * Training and mentorship opportunities. * On-campus wellness activities. * Education reimbursement program. * 401(k) program with discretionary employer match. * Generous vacation accrual and paid holiday schedule. Please note that the compensation range may be adjusted in the future, and bonus and incentive compensation plans may apply. Our total reward package reflects our commitment to employee growth and well-being, as we invest in your development and offer a range of benefits designed to enhance your career and life. All compensation and benefits are subject to plan documents and written agreements. Equal Opportunity Employer Applied Medical is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to age, ancestry, color, disability (mental and physical), exercising the right to family care and medical leave, gender, gender expression, gender identity, genetic information, marital status, medical condition, military or veteran status, national origin, political affiliation, race, religious creed, sex (including pregnancy, childbirth, breastfeeding and related medical conditions), or sexual orientation, or any other status protected by federal, state or local laws in the locations where Applied Medical operates.
    $18-23 hourly Auto-Apply 60d+ ago
  • Quality Control Inspector

    Endologix 4.7company rating

    Santa Rosa, CA jobs

    Join our mission-driven Quality team as the Quality Control Inspector at Endologix! WHO WE ARE: Endologix LLC is a California-based global medical device company dedicated to improving patients' lives through innovative therapies for the interventional treatment of vascular disease. Our therapeutic portfolio addresses clinically relevant unmet needs, spanning from abdominal aortic aneurysms to lower limb peripheral vascular disease. We are committed to delivering excellent clinical outcomes through precision in product design, advanced manufacturing, and comprehensive physician training-supported by industry-leading clinical evidence. At Endologix, we're driven by purpose, innovation, and the opportunity to make a lasting impact in vascular health. What sets us apart is not just our technology, but our culture. At Endologix, we foster a forward-thinking, mission-driven environment where every team member plays a vital role in advancing patient care. Our values guide how we operate: we prioritize patient outcomes, act with integrity, stay curious and innovative, move boldly in pursuit of excellence, and collaborate across teams and with physicians to achieve exceptional results. As for our people? We empower them with the tools, trust, and continuous learning they need to grow. If you're passionate about making a meaningful difference in healthcare, you'll find purpose and belonging here. ABOUT THE ROLE: We're looking for a Quality Control Inspector to join our mission-driven Quality team. In this role, you'll be responsible for performing inspections of components, subassemblies, and finished medical devices to ensure compliance with quality standards and regulatory requirements. This includes conducting quality checks, performance tests, reviewing documentation, and verifying Device History Records (DHR) for product release in accordance with the medical device Quality Management System (QMS). Responsibilities WHAT YOU'LL DO: * Perform audits, inspections, configuration checks, and functional testing to ensure product quality and compliance with established procedures. * Review and verify lot history records for completeness, accuracy, and adherence to SOPs; investigate records related to customer experience reports. * Inspect subassemblies, finished products, purchased components, and tools using defined criteria and standard mechanical, and/or electrical measurements. * Conduct product rework on subassemblies or finished goods as required. * Accurately document inspection and testing results in compliance with Good Documentation Practices (GDP). * Review Device History Records (DHR) for compliance with established procedures and GDP requirements. * Identify issues and provide initial recommendations for corrective actions or process improvements to supervisors. * Perform product testing to ensure conformance to quality standards. * Work within a cleanroom environment, following all applicable protocols and safety requirements. * Perform temperature and particle count monitoring; manage ERP (QAD) and MES application transactions; handle multiple tasks efficiently in a fast-paced manufacturing environment. * Perform other duties as assigned by the supervisor. * Demonstrate punctuality, reliability, and a strong work ethic. Qualifications WHAT YOU'LL BRING: Education: * High School Diploma or equivalent required. Experience: * 1-5 years of Quality Control experience, preferably in the medical device industry. Skills/Competencies: * Ability to understand and follow technical procedures, work instructions, and basic specifications related to the inspection of products and components. * Skill in identifying relevant information in technical drawings and documents and reporting any discrepancies to the supervisor. * Familiarity with applicable quality standards and willingness to learn about specific regulations under supervision * Mechanical aptitude and working knowledge of measurement instruments. * Strong written and verbal communication skills for reports, correspondence, and presentations. * Mathematical proficiency in fractions, percentages, ratios, and proportions. * Problem-solving skills with the ability to work in a cross-functional environment and manage multiple priorities. WHAT WE OFFER: At Endologix, we know that great work starts with great people - and people do their best when they feel valued and supported. That's why we offer competitive pay, solid benefits, career growth, a culture that genuinely cares, and the flexibility you need to thrive both at work and at home. But more than that, we offer purpose. You'll be part of a team that's making a real impact on patients' lives. When you join us, you're not just taking a job, you're building a meaningful career with a team that's invested in your success. The compensation package includes: * Hourly rate of $24.03/hr-$29.44/hr * Discretionary bonus * Equity participation as approved by Board of Directors (4-year vesting schedule) * Comprehensive health, dental, and vision insurance plans * Generous PTO and holiday schedule * 401(k) retirement plan with company match Plus: * Employee wellness initiatives and mental health support * Collaborative and inclusive company culture focused on impact and innovation * Opportunities for career growth and internal mobility HOW WE LEAD WITH OUR CORE VALUES: * Patient Outcomes Drive Us: We improve lives with every advancement we deliver. * Integrity Defines Us: We do what's right, stay transparent, prioritize quality, and own our actions. * Innovation Advances Us: We stay curious, adaptable, and push boundaries. * Boldness Propels Us: We take smart risks and are unafraid in our pursuit of excellence. * Collaboration Unites Us: We partner across teams and with physicians to drive exceptional results. OUR COMMITMENT TO EQUAL OPPORTUNITY & VETERAN INCLUSION: Endologix LLC is an Equal Opportunity and Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, or any other characteristic protected by applicable federal, state, or local law. As a federal contractor, Endologix LLC is committed to taking affirmative action to recruit, employ, and advance in employment qualified individuals with disabilities and protected veterans.
    $24-29.4 hourly Auto-Apply 20d ago
  • QC Incoming Inspector I

    Anika Therapeutics 4.3company rating

    Bedford, MA jobs

    Summary of Primary Responsibilities: The QC Incoming Inspector completes all activities required to approve raw materials for use in product manufacture. The position also performs inspection activities during in-process manufacturing. Specific Responsibilities: Perform quality line clears and in process inspections during the inspection and packing processes according to specific SOP requirements Issue lot numbers and control labels for incoming raw materials; perform inspections per internal procedures and specifications Release approved raw materials for use in manufacturing process to include completion of associated documents, notice of approval form (bin card) and relabeling of inventory Review MPS of other incoming inspectors for approval and release. Monitor and perform annual retain inspection; coordinate required retesting with QC; complete required documentation Perform OOS investigations and participate in MRB as required for rejected materials Perform as SME for the function and provide training as required to new employees, contractors and other QA personnel Perform biennial review for designated procedures and MPS as needed Documents; author and complete DCR as required Document all work activities according to Good Documentation Practices Maintain current training on all assigned procedures to include read & understood, skills development and classroom training activities as required Participate in other projects as assigned Job Complexity: The position works on assignments that are routine in nature and receives detailed instruction on all work. Supervisory Responsibilities: None Required Qualifications: Associates degree in the life science or relevant work experience 0 - 1 year of experience in a cGMP facility or previous experience in a QA/QC role within the industry; internship experience considered Experience using Microsoft Office or an ERP system Desired Experience, Knowledge, and Skills: Bachelor's degree preferred Experience working in a clean room environment Excellent communication and documentation skills The salary range provided is based on the Company's reasonable estimate of the base salary pay range for this position at the time of posting. Actual base pay is determined by several factors relevant to the position, including skills, competencies, experience, education, and geographic location. Anika also offers a discretionary bonus program for all full-time employees, comprehensive healthcare benefits, health savings account, 401(k) plan with up to 5% company match which includes immediate vesting, employee stock purchase plan at a 15% discount, accrued paid time off, additional long-term incentives including stock awards, and much more. At Anika, we take pride in offering robust Total Rewards, inclusive of market-leading benefits to meet our employees where they are in their career and in life. The compensation and benefits information is provided as of the date of this posting. Anika reserves the right to modify compensation and benefits at any time, subject to applicable law.
    $41k-60k yearly est. Auto-Apply 60d+ ago
  • QC Incoming Inspector I, 1st Shift

    Anika Therapeutics 4.3company rating

    Bedford, MA jobs

    Salary Range:$45,000.00 To $55,000.00 Annually Summary of Primary Responsibilities: The QC Incoming Inspector completes all activities required to approve raw materials for use in product manufacture. The position also performs inspection activities during in-process manufacturing. Specific Responsibilities: * Perform quality line clears and in process inspections during the inspection and packing processes according to specific SOP requirements * Issue lot numbers and control labels for incoming raw materials; perform inspections per internal procedures and specifications * Release approved raw materials for use in manufacturing process to include completion of associated documents, notice of approval form (bin card) and relabeling of inventory * Review MPS of other incoming inspectors for approval and release. * Monitor and perform annual retain inspection; coordinate required retesting with QC; complete required documentation * Perform OOS investigations and participate in MRB as required for rejected materials * Perform as SME for the function and provide training as required to new employees, contractors and other QA personnel * Perform biennial review for designated procedures and MPS as needed * Documents; author and complete DCR as required * Document all work activities according to Good Documentation Practices * Maintain current training on all assigned procedures to include read & understood, skills development and classroom training activities as required * Participate in other projects as assigned Job Complexity: The position works on assignments that are routine in nature and receives detailed instruction on all work. Supervisory Responsibilities: None Required Qualifications: * Associates degree in the life science or relevant work experience * 0 - 1 year of experience in a cGMP facility or previous experience in a QA/QC role within the industry; internship experience considered * Experience using Microsoft Office or an ERP system Desired Experience, Knowledge, and Skills: * Bachelor's degree preferred * Experience working in a clean room environment * Excellent communication and documentation skills The salary range provided is based on the Company's reasonable estimate of the base salary pay range for this position at the time of posting. Actual base pay is determined by several factors relevant to the position, including skills, competencies, experience, education, and geographic location. Anika also offers a discretionary bonus program for all full-time employees, comprehensive healthcare benefits, health savings account, 401(k) plan with up to 5% company match which includes immediate vesting, employee stock purchase plan at a 15% discount, accrued paid time off, additional long-term incentives including stock awards, and much more. At Anika, we take pride in offering robust Total Rewards, inclusive of market-leading benefits to meet our employees where they are in their career and in life. The compensation and benefits information is provided as of the date of this posting. Anika reserves the right to modify compensation and benefits at any time, subject to applicable law. submit your resume We are an equal opportunity employer, and we do not tolerate discrimination based on characteristics such as age, gender, gender identity and expression, genetic status, sexual orientation, race, ethnicity, national origin, religion, disability, military status, family status, or any other protected category under federal, state, or local law.
    $45k-55k yearly 60d+ ago
  • Quality Control Labeling Inspector

    Vivex Biologics 3.7company rating

    Miami, FL jobs

    Job Purpose The QC Labeling Inspector is responsible for maintaining a high level of inventory accuracy and integrity within the Tissue Bank. Performs final product labeling and inspections, manages transport and storage of quarantine tissue, and maintains labeling supplies. Promotes Lean Behaviors across the organization (This includes Participating in Try storming, Brainstorming and Lean Related Initiatives). Promotes Usage of Problem Solving. Ensure that Labeling Operations are in Compliance with the State and Federal Regulations and AATB Standards. Duties and Responsibilities Preparation of the QC Labeling areas as specifically described in SOPs. Performs final inspection of products for proper specifications, label accuracy, and compliance with applicable regulations, standards and Vivex Biologics, Inc. quality requirements. Combines components for final products. Applies labels to final product and adds package inserts, boxes, etc. Maintains accurate inventory of post-processing, quarantine products (frozen and room temperature). Performs disposition of nonconforming products as directed. Coordinates and stages products for sterilization. Monitors freezers and responds to alarms. Supports nonconformance investigations, when applicable. Maintains knowledge of applicable regulations and standards related to storage, handling, labeling and inspections of tissue. Maintains effective communication with management when issues arise to obtain appropriate instructions to address the issues. Performs other duties as assigned by management. Requirements Qualifications High School/Minimum of 4 Years of Relevant Experience. Associate/Minimum of 1 Years of Relevant experience. Bachelors/Minimum of 0-1 Years of Relevant experience Working Conditions Work is indoors in environmentally controlled conditions. Overtime may be required to meet production deadlines. Some on-call and weekends may be required. Physical Requirements Able to stand for extended period. Able to lift 25 lbs. without assistance. Must be able to infrequently lift, push, pull and carry boxes weighing up to 25 pounds. Walk, squat and bend over for intervals of 15-30 minutes, with or without reasonable accommodation. Direct Reports No direct reports. Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job any time. Vivex Biologics, Inc. is an equal opportunity employer (EEO) and expressly prohibits any form of workplace discrimination and/or harassment based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, genetic information, disability, or veteran status. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, transfers, leaves of absence, compensation and training. Vivex Biologics, Inc. with the Americans with Disability Act (ADA) which prohibits discrimination against qualified individuals with disabilities who, with or without reasonable accommodation, can perform the essential functions of a job.
    $32k-44k yearly est. 60d+ ago
  • Quality Control (QC) Roving Inspector

    Acero Precision 4.1company rating

    West Chester, PA jobs

    Now Hiring!! Company: Acero Precision Salary Information: $20.00 - $26.00 🕒 Full-Time | On-site | Some Weekend Availability Why Join the Acero Precision Team? Acero Precision, located in West Chester, PA is an industry leading Medical Device contract manufacturer producing the very best in precision engineered components. To succeed in today's manufacturing industry- with its demands to serve customers in a truly global environment- we rely on three vital resources: the newest engineering technologies, quality systems, and most importantly highly-skilled people. We invite you to become a member of an organization that has established an outstanding reputation for quality and excellence. Highly competitive wages, a state-of-the-art-facility, an emphasis on work/life balance, career advancement, a team-centered workplace culture, and the opportunity to be your best is waiting for you at Acero Precision. Why You'll Love Working Here We offer defined career advancement opportunities for employees seeking long-term growth within our organization Competitive premium pay for 1st shift Overtime hours available Weekend premiums available Multiple health insurance plans, including a no-cost HSA health plan for eligible employees. Affordable Dental, and Vision benefits 100% Paid Uniforms 401k with employer match Paid training on advanced CNC programming software This role offers 100 hours of PTO in the first year, with PTO increasing at defined service milestones. 7 paid holidays every year State-of-the-art, climate-controlled facility with 5-axis and Swiss turning Employee Assistance Program (EAP) offering free confidential support services to employees and their families. Access to our Wellness Coach Program Be the eyes of precision. Join a team where quality is more than a goal-it's a way of life. Are you a detail-oriented quality professional with a passion for excellence in manufacturing? Acero Precision is seeking a dedicated Quality Control Roving Inspector to uphold and elevate our industry-leading standards. What You'll Do As a Quality Control Roving Inspector, you'll be the frontline advocate for our customers-ensuring every part meets our rigorous quality standards. Your day-to-day will include: Conducting in-process and final inspections across multiple machines and cells. Collaborating with machinists, production team leads, and quality controllers to identify and resolve non-conformances. Maintaining ISO 9001 and ISO 13485 compliance. Coaching Final Inspectors and training production staff on inspection tools and quality processes. Leading by example in inspection practices and quality improvement. Your Impact Ensure product accuracy and compliance using the Monitor Report and Sponge Data System. Maintain inspection equipment and accurate calibration records. Act as a quality “help desk” for operators and a mentor for new team members. Support continuous improvement by generating NCRs and developing corrective actions. What You Bring Bachelor's degree in Engineering or a related field, or equivalent experience. 5+ years of quality experience in a precision machining environment. Working knowledge of ISO 9001 and 13485 standards. Proficiency with inspection tools: calipers, micrometers, comparators, etc. Strong communication, problem-solving, and organizational skills. Willingness to work 50+ hours weekly, including occasional weekends. Bonus Points CNC/Swiss machining experience Quality certifications (e.g., CQT, CQI, Six Sigma) Acero Precision is proud to be an Equal Opportunity Employer. Acero Precision does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status, or any basis covered by appropriate law. All employment is decided on the basis of qualifications, merit and business need. *Principals only. Recruiters please do not apply on behalf of your candidates to Acero Precision job posts. All applications and/or contact information submitted are kept on file and are the property of Acero Precision. Please note recruiting fees will not be honored with candidate applications submitted by recruiters. Make Our Mission Your Mission!
    $31k-44k yearly est. 7d ago
  • Quality Control (QC) Roving Inspector

    Acero Precision 4.1company rating

    West Chester, PA jobs

    Job Description Now Hiring!! Company: Acero Precision Salary Information: $20.00 - $26.00 ???? Full-Time | On-site | Some Weekend Availability Why Join the Acero Precision Team? Acero Precision, located in West Chester, PA is an industry leading Medical Device contract manufacturer producing the very best in precision engineered components. To succeed in today's manufacturing industry- with its demands to serve customers in a truly global environment- we rely on three vital resources: the newest engineering technologies, quality systems, and most importantly highly-skilled people. We invite you to become a member of an organization that has established an outstanding reputation for quality and excellence. Highly competitive wages, a state-of-the-art-facility, an emphasis on work/life balance, career advancement, a team-centered workplace culture, and the opportunity to be your best is waiting for you at Acero Precision. Why You'll Love Working Here We offer defined career advancement opportunities for employees seeking long-term growth within our organization Competitive premium pay for 1st shift Overtime hours available Weekend premiums available Multiple health insurance plans, including a no-cost HSA health plan for eligible employees. Affordable Dental, and Vision benefits 100% Paid Uniforms 401k with employer match Paid training on advanced CNC programming software This role offers 100 hours of PTO in the first year, with PTO increasing at defined service milestones. 7 paid holidays every year State-of-the-art, climate-controlled facility with 5-axis and Swiss turning Employee Assistance Program (EAP) offering free confidential support services to employees and their families. Access to our Wellness Coach Program Be the eyes of precision. Join a team where quality is more than a goal-it's a way of life. Are you a detail-oriented quality professional with a passion for excellence in manufacturing? Acero Precision is seeking a dedicated Quality Control Roving Inspector to uphold and elevate our industry-leading standards. What You'll Do As a Quality Control Roving Inspector, you'll be the frontline advocate for our customers-ensuring every part meets our rigorous quality standards. Your day-to-day will include: Conducting in-process and final inspections across multiple machines and cells. Collaborating with machinists, production team leads, and quality controllers to identify and resolve non-conformances. Maintaining ISO 9001 and ISO 13485 compliance. Coaching Final Inspectors and training production staff on inspection tools and quality processes. Leading by example in inspection practices and quality improvement. Your Impact Ensure product accuracy and compliance using the Monitor Report and Sponge Data System. Maintain inspection equipment and accurate calibration records. Act as a quality “help desk” for operators and a mentor for new team members. Support continuous improvement by generating NCRs and developing corrective actions. What You Bring Bachelor's degree in Engineering or a related field, or equivalent experience. 5+ years of quality experience in a precision machining environment. Working knowledge of ISO 9001 and 13485 standards. Proficiency with inspection tools: calipers, micrometers, comparators, etc. Strong communication, problem-solving, and organizational skills. Willingness to work 50+ hours weekly, including occasional weekends. Bonus Points CNC/Swiss machining experience Quality certifications (e.g., CQT, CQI, Six Sigma) Acero Precision is proud to be an Equal Opportunity Employer. Acero Precision does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status, or any basis covered by appropriate law. All employment is decided on the basis of qualifications, merit and business need. *Principals only. Recruiters please do not apply on behalf of your candidates to Acero Precision job posts. All applications and/or contact information submitted are kept on file and are the property of Acero Precision. Please note recruiting fees will not be honored with candidate applications submitted by recruiters. Make Our Mission Your Mission!
    $31k-44k yearly est. 8d ago
  • Quality Control (QC) Roving Inspector

    Acero Precision 4.1company rating

    West Chester, PA jobs

    Now Hiring!! Company: Acero Precision Salary Information: $20.00 - $26.00 Full-Time | On-site | Some Weekend Availability Why Join the Acero Precision Team? Acero Precision, located in West Chester, PA is an industry leading Medical Device contract manufacturer producing the very best in precision engineered components. To succeed in today's manufacturing industry- with its demands to serve customers in a truly global environment- we rely on three vital resources: the newest engineering technologies, quality systems, and most importantly highly-skilled people. We invite you to become a member of an organization that has established an outstanding reputation for quality and excellence. Highly competitive wages, a state-of-the-art-facility, an emphasis on work/life balance, career advancement, a team-centered workplace culture, and the opportunity to be your best is waiting for you at Acero Precision. Why You'll Love Working Here * We offer defined career advancement opportunities for employees seeking long-term growth within our organization * Competitive premium pay for 1st shift * Overtime hours available * Weekend premiums available * Multiple health insurance plans, including a no-cost HSA health plan for eligible employees. * Affordable Dental, and Vision benefits * 100% Paid Uniforms * 401k with employer match * Paid training on advanced CNC programming software * This role offers 100 hours of PTO in the first year, with PTO increasing at defined service milestones. * 7 paid holidays every year * State-of-the-art, climate-controlled facility with 5-axis and Swiss turning * Employee Assistance Program (EAP) offering free confidential support services to employees and their families. * Access to our Wellness Coach Program Be the eyes of precision. Join a team where quality is more than a goal-it's a way of life. Are you a detail-oriented quality professional with a passion for excellence in manufacturing? Acero Precision is seeking a dedicated Quality Control Roving Inspector to uphold and elevate our industry-leading standards. What You'll Do As a Quality Control Roving Inspector, you'll be the frontline advocate for our customers-ensuring every part meets our rigorous quality standards. Your day-to-day will include: * Conducting in-process and final inspections across multiple machines and cells. * Collaborating with machinists, production team leads, and quality controllers to identify and resolve non-conformances. * Maintaining ISO 9001 and ISO 13485 compliance. * Coaching Final Inspectors and training production staff on inspection tools and quality processes. * Leading by example in inspection practices and quality improvement. Your Impact * Ensure product accuracy and compliance using the Monitor Report and Sponge Data System. * Maintain inspection equipment and accurate calibration records. * Act as a quality "help desk" for operators and a mentor for new team members. * Support continuous improvement by generating NCRs and developing corrective actions. What You Bring * Bachelor's degree in Engineering or a related field, or equivalent experience. * 5+ years of quality experience in a precision machining environment. * Working knowledge of ISO 9001 and 13485 standards. * Proficiency with inspection tools: calipers, micrometers, comparators, etc. * Strong communication, problem-solving, and organizational skills. * Willingness to work 50+ hours weekly, including occasional weekends. Bonus Points CNC/Swiss machining experience Quality certifications (e.g., CQT, CQI, Six Sigma) Acero Precision is proud to be an Equal Opportunity Employer. Acero Precision does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status, or any basis covered by appropriate law. All employment is decided on the basis of qualifications, merit and business need. * Principals only. Recruiters please do not apply on behalf of your candidates to Acero Precision job posts. All applications and/or contact information submitted are kept on file and are the property of Acero Precision. Please note recruiting fees will not be honored with candidate applications submitted by recruiters. Make Our Mission Your Mission!
    $31k-44k yearly est. 7d ago
  • QC Inspector

    The Sunrider Corporation 4.2company rating

    Midlothian, TX jobs

    Oversees logs and procedures and ensures Q.C. and Production are abiding by GMP and GLP company rules set forth by company SOPs. Ensuring things are made right in the first place is the best way of preventing out of specification products. ESSENTIAL DUTIES AND RESPONSIBILITIES: Includes the following, but other duties may be assigned as the company's needs dictate. Reviews and approves the Production filling batch records. Checks and audits the documents for accuracy and GMP compliance during and at the completion of filling. Checks and confirms that the correct components and compounding batch have been set-up and are being used on the appropriate packaging line. Reviews the data reported by the mechanics, machine operators, and line leads to ensure that the information is correct and entered appropriately. Responsible for placing compounded batches and finished goods that do not conform to company specifications into Quarantine status with applicable labeling. Reports any quality issues to Quality management and participates in investigations, as necessary. Performs daily housekeeping audits of the Production area logbooks and reports results to Quality management. Supports GMP training of employees. Participates in Quality System audits as directed by Quality management. Complies with Health, Safety, and Environmental responsibilities for the position. Inspects the production lines to ensure that both Production and Quality control personnel are following the required SOP to perform their jobs. 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. EDUCATION and/or EXPERIENCE: High school diploma or GED (general education degree) and some college (science-based courses preferred). Minimum 6-months of hands-on experience as Quality audit/inspector in cGMP environment; preferably in pharmaceutical, biomedical, or medical device field (regulated industry). Experience with batch record keeping, CAPA initiation, and deviation investigation. Should have experience working on the floor of a manufacturing facility. LANGUAGE SKILLS: Fluent in reading, writing, and speaking the English language, as well as having experience with technical writing (knowing Spanish is a plus). Ability to read, analyze, and interpret professional journals, technical procedures, or governmental regulations. Ability to write reports, business correspondence, and procedure manuals. Ability to effectively present information and respond to questions from departmental manager/supervisor or other employees. MATHEMATICAL SKILLS: Ability to apply mathematical operations to such tasks as frequency distribution, determination of test reliability and validity, analysis of variance, correlation techniques, sampling theory, and factor analysis. COMPUTER SKILLS: To perform this job successfully, an individual should have knowledge of Database software, Spreadsheet software and Word Processing software. REASONING ABILITY: Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables. 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 frequently required to sit, use hands to finger, handle or feel; and reach with hands and arms. The employee is occasionally required to stand, walk, talk or hear, and taste and smell. The employee must occasionally lift and/or move up to 10 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral 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. While performing the duties of this job, the employee is frequently exposed to fumes or airborne particles (herbal powders). The noise level in the work environment is usually quiet. Sunrider Manufacturing 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. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.
    $31k-40k yearly est. Auto-Apply 14d ago
  • Inspection & Packaging Lead (3rd shift)

    Leiters Health 3.9company rating

    Englewood, CO jobs

    Job Description Inspection & Packaging Lead (3rd shift) This position reports directly to the Inspection and Packaging Supervisors as well as the VILP Manager. The role is responsible for general support of the Visual Inspection, Labeling, and Packaging of finished sterile compounds. The Lead is responsible for ensuring the accuracy for label reconciliation, document completeness and correctness of all product identification. Why Join Leiters Health? Are you passionate about making a real impact in the pharmaceutical industry? Do you thrive in a collaborative, innovative environment where your skills and ideas are valued? Look no further - Leiters Health is seeking talented individuals like you to join our dynamic team! At Leiters Health, we're not just another pharmaceutical company - we're pioneers in the field, dedicated to delivering high-quality compounded sterile products and outsourced solutions to healthcare providers nationwide. Our commitment to excellence and patient safety is at the core of everything we do. Innovative Culture: Be part of a forward-thinking company that encourages creativity, welcomes fresh ideas, and fosters an environment of continuous improvement. Meaningful Work: Contribute to a purpose-driven organization dedicated to providing critical medications and healthcare solutions that positivelyimpactpatients' lives. Professional Development: Access ongoing training, mentorship, and growth opportunities to expand your skills and advance your career within a rapidly growing industry. Cutting-EdgeTechnology: Work withstate-of-the-artfacilities and advanced technologies, staying ahead of the curve in pharmaceutical manufacturing. Collaborative Environment: Join a team of passionate individuals who are dedicated to teamwork, support, and mutual success, fostering a culture of inclusivity and collaboration. Who We're Looking For: We're seeking enthusiastic individuals who are driven, adaptable, and passionate about contributing to a mission-driven organization. Whether you're an experienced professional or just starting your career, Leiters Health provides an environment where your skills and talents will be recognized and appreciated. Sound like you? Apply today! Essential Functions: Lead and perform the line/area clearance of the visual inspection or label, and packaging activities. Review of batch record during and end of visual inspection, label, and packaging activities. Assist Inspection & Packaging Supervisors in overseeing employees who are responsible for visual inspection/labeling/packaging of finished goods. Collaborate with Inspection & Packaging Supervisors to ensure timely visual inspection and labeling of products to meet scheduled batch release dates. Ensure that training on SOPs and processes remains current. Analyze Production efficiencies downtime and waste. Lead teams to improve the results. Write investigations and CAPA actions for non-conformances in the department. Work with QA to quickly resolve any variance or document errors so that product may be released on time. Lead Problem Solving activities. Assist with maintaining batch and label inventory and managing daily staffing for visual inspection and labeling. Other duties as assigned. Supervisory Responsibilities: Lead a team of Associates, providing direction, support, and training. Provide a positive and collaborative work environment through effective communication and accountability, escalating conflict promptly and fairly. Experience and Necessary Skills: 1-year previous leadership experience or comparable experience preferred. Minimum 1 years' experience in aseptic processing preferred. Knowledge of cGMP guidelines/standards. Bachelor's degree or relevant experience preferred. Demonstrated written and oral communications skills including strong presentation skills. Excellent organizational skills and results oriented. Strong results orientation. Strong Microsoft Office skills are essential, proficient in the use of spreadsheets and word processing programs Ability to effectively bring others together and reconcile differences. Able to lift up to 50 lbs. and stand for extended periods when required Must pass an eye exam confirming 20/20 near vision corrected (with contacts or glasses) or uncorrected Must pass an eye exam confirming the ability to accurately perceive color Benefits: Smart healthcare coverage options that rewards wellness (and puts money back in your pocket!) Flexible Spending & Health Savings Accounts (FSA & HSA) available Dental & Vision insurance Employer Paid Life Insurance & Employee Assistance Program Short Term & Long-Term Disability Insurance Up to 4% 401K Matching (100% vested on day one!) Generous Paid Time Off Options - vacation,sick, paid leave and holidays! $5,250 Annual Tuition Reimbursement after 6 months $1,000 Referral Bonus Program with no limit Eligible for annual bonus program Timeline: We will be accepting applications on an ongoing basis until position is filled. We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, genetic information, protected veteran status, or any other characteristic protected by law. *Please note that we do not work with third-party recruiters or agencies for this position. If you are a qualified candidate and wish to apply for this job, please do so directly through our official application process. We appreciate your understanding and cooperation in this matter. Monday - Friday 1130pm to 8am
    $38k-52k yearly est. 27d ago
  • Inspection & Packaging Lead (3rd shift)

    Leiters Inc. 3.9company rating

    Englewood, CO jobs

    Inspection & Packaging Lead (3rd shift) This position reports directly to the Inspection and Packaging Supervisors as well as the VILP Manager. The role is responsible for general support of the Visual Inspection, Labeling, and Packaging of finished sterile compounds. The Lead is responsible for ensuring the accuracy for label reconciliation, document completeness and correctness of all product identification. Why Join Leiters Health? Are you passionate about making a real impact in the pharmaceutical industry? Do you thrive in a collaborative, innovative environment where your skills and ideas are valued? Look no further - Leiters Health is seeking talented individuals like you to join our dynamic team! At Leiters Health, we're not just another pharmaceutical company - we're pioneers in the field, dedicated to delivering high-quality compounded sterile products and outsourced solutions to healthcare providers nationwide. Our commitment to excellence and patient safety is at the core of everything we do. Innovative Culture: Be part of a forward-thinking company that encourages creativity, welcomes fresh ideas, and fosters an environment of continuous improvement. Meaningful Work: Contribute to a purpose-driven organization dedicated to providing critical medications and healthcare solutions that positivelyimpactpatients' lives. Professional Development: Access ongoing training, mentorship, and growth opportunities to expand your skills and advance your career within a rapidly growing industry. Cutting-EdgeTechnology: Work withstate-of-the-artfacilities and advanced technologies, staying ahead of the curve in pharmaceutical manufacturing. Collaborative Environment: Join a team of passionate individuals who are dedicated to teamwork, support, and mutual success, fostering a culture of inclusivity and collaboration. Who We're Looking For: We're seeking enthusiastic individuals who are driven, adaptable, and passionate about contributing to a mission-driven organization. Whether you're an experienced professional or just starting your career, Leiters Health provides an environment where your skills and talents will be recognized and appreciated. Sound like you? Apply today! Essential Functions: Lead and perform the line/area clearance of the visual inspection or label, and packaging activities. Review of batch record during and end of visual inspection, label, and packaging activities. Assist Inspection & Packaging Supervisors in overseeing employees who are responsible for visual inspection/labeling/packaging of finished goods. Collaborate with Inspection & Packaging Supervisors to ensure timely visual inspection and labeling of products to meet scheduled batch release dates. Ensure that training on SOPs and processes remains current. Analyze Production efficiencies downtime and waste. Lead teams to improve the results. Write investigations and CAPA actions for non-conformances in the department. Work with QA to quickly resolve any variance or document errors so that product may be released on time. Lead Problem Solving activities. Assist with maintaining batch and label inventory and managing daily staffing for visual inspection and labeling. Other duties as assigned. Supervisory Responsibilities: Lead a team of Associates, providing direction, support, and training. Provide a positive and collaborative work environment through effective communication and accountability, escalating conflict promptly and fairly. Experience and Necessary Skills: 1-year previous leadership experience or comparable experience preferred. Minimum 1 years' experience in aseptic processing preferred. Knowledge of cGMP guidelines/standards. Bachelor's degree or relevant experience preferred. Demonstrated written and oral communications skills including strong presentation skills. Excellent organizational skills and results oriented. Strong results orientation. Strong Microsoft Office skills are essential, proficient in the use of spreadsheets and word processing programs Ability to effectively bring others together and reconcile differences. Able to lift up to 50 lbs. and stand for extended periods when required Must pass an eye exam confirming 20/20 near vision corrected (with contacts or glasses) or uncorrected Must pass an eye exam confirming the ability to accurately perceive color Benefits: Smart healthcare coverage options that rewards wellness (and puts money back in your pocket!) Flexible Spending & Health Savings Accounts (FSA & HSA) available Dental & Vision insurance Employer Paid Life Insurance & Employee Assistance Program Short Term & Long-Term Disability Insurance Up to 4% 401K Matching (100% vested on day one!) Generous Paid Time Off Options - vacation,sick, paid leave and holidays! $5,250 Annual Tuition Reimbursement after 6 months $1,000 Referral Bonus Program with no limit Eligible for annual bonus program Timeline: We will be accepting applications on an ongoing basis until position is filled. We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, genetic information, protected veteran status, or any other characteristic protected by law. *Please note that we do not work with third-party recruiters or agencies for this position. If you are a qualified candidate and wish to apply for this job, please do so directly through our official application process. We appreciate your understanding and cooperation in this matter. Monday - Friday 1130pm to 8am
    $38k-52k yearly est. Auto-Apply 22d ago

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