Quality Control Inspector jobs at Stryker - 569 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

A leading medical technology company is looking for a Quality Inspector in Salt Lake City. The role involves visual, dimensional, and functional inspections of medical devices, ensuring they meet design specifications. Candidates must have a high school diploma and strong attention to detail. Preferred skills include manual dexterity and basic computer skills. The position offers a pay rate of $19.44/hr and is scheduled Monday to Thursday from 3:45pm to 2:15am. #J-18808-Ljbffr

Under direct and indirect supervision, performs mammography and DEXA examinations with physician supervision; maintains responsibility for monitoring and quality control of all mammographic and DEXA studies. Monitors and assists with direction and technical operation of mammography and DEXA examinations subsection; assists with workflow coordination. Assumes direct control of specific areas within Mammography and DEXA as assigned. Manages the Quality Control (QC) initiatives at assigned facility. Essential Responsibilities: + Monitors technical and clinical performance of mammographers assigned to Mammography and DEXA section, and provides assistance to staff as needed. Remains responsible for quality control procedures for assigned Mammography and DEXA section. + Completes patient history/breast assessment and/or DEXA patient fracture assessment form and transmits form into the Radiology PACS system. + Performs mammography and DEXA studies and procedures. Positions patients, applies compression, provides immobilization means and patient counseling as required. Selects technical factors and protocols that result in optimum imaging for each individual patient. Reviews orders with peers and consults with attending Radiologists as needed. Maintains daily records of exams performed. May perform stereotactic biopsy procedures. + Follows all National Patient Safety Goals. Receives and double identifies patients using appropriate criteria prior to performing the study ordered. Ensures accruacy of information and data entry, while maintaining patient privacy and confidentiality. Captures required documentation in Radiology Information System (RIS.) + Prepares sterile fields as required and directed; prepares floor stock medications; ensures sterility of surgical packs, trays and disposables to be used in assigned area. Maintains appropriate and adequate supplies during the procedures. Remains proficient in performing breast localizations as pre-biopsy procedure; remains proficient in performing stereotactic breast biopsy if applicable. + Assists radiologist during exams and procedures as needed; capturing specific mammography images and assisting with biopsy specimen collection. Operates and understands all features and performance capabilities of the mammography and DEXA systems: performs system quality control (QC) as required. Demonstrates sufficient knowledge for all quality control tests to include daily, weekly, monthly, quarterly, and semi-annual testing; performs quality control tests when assigned. Maintains FDA and MQSA records, guidelines to meet accreditation standards. + Post processes and performs quality control (QC) of mammography images and DEXA images as required; prepares images for Radiologist interpretation, and transmits images to the Diagnostic Imaging PACS system. + Maintains working knowledge of all department equipment and devices. Recognizes, corrects, or reports radiographic equipment malfunctions to Service Engineer and/or Physicist. + Monitors and assures prompt, efficient patient flow with minimal waiting time; provides assistance during patient schedule conflicts; advises receptionists as to appropriate schedule revisions and assures efficient patient flow. + Assumes responsibilities for the needs of patient during procedure. Provides fear/stress reducing service-oriented communication with patient; explaining procedure; answering questions; providing encouragement. Emphasizes a personalized, individualized, compassionate patient care atmosphere at all times. Dismisses patients for transport and/or assists with patient transport at end of procedure. + Provides instructions on appropriate safety measures to patients, family members, and hospital staff as required; ensures appropriate safety precautions are followed. Applies appropriate measures (ALARA Principles) for minimizing radiation exposure. Captures and records radiation dose delivered during the procedure. + Functions as part of resuscitation team during Code Blue and/or Rapid Response Team situations. + Orients and trains (mentors) new personnel regarding subsection operations as needed. Trains mammographers to maintain high level of image quality as well as adherence to departmental rules, standards and protocols. Maintains high personal level of competency in this area to provide constant resource for teaching and training. + Maintains all materials needed and linen supply on daily basis; maintains general order and cleanliness of room assigned. + Pursues ongoing continuing education. + Attends departmental meetings and/or inservice presentations as needed or required. Reads and initials minutes of such meetings when excused absence precludes attendance. + Evaluates productivity and patient care performances. Reports substandard levels appropriately. Advises manager of real or potential problems concerning discipline, morale, technical competency, interpersonal relations, etc. Basic Qualifications: Experience + Minimum three (3) years mammography experience. Education + Associates degree in radiologic technology; or two (2) years of experience in a directly related field. + Specialty training in technical and interpretive aspects of mammography. License, Certification, Registration + Radiographer License (Hawaii) + American Registry of Radiologic Technologists Certificate - Mammography Technologist + Basic Life Support Additional Requirements: + Ability to coordinate work of others. Preferred Qualifications: + Team Leader experience. + MQSA and/or ACR Quality Control experience in high volume setting. + Teaching or training experience. + Training in MQSA and ACR Quality Control initiatives. COMPANY: KAISER TITLE: Mammograph Technologist Lead/Quality Control LOCATION: Wailuku, Hawaii REQNUMBER: 1378210 External hires must pass a background check/drug screen. Qualified applicants with arrest and/or conviction records will be considered for employment in a manner consistent with Federal, state and local laws, including but not limited to the San Francisco Fair Chance Ordinance. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, protected veteran, or disability status.

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

A leading healthcare organization is seeking a Quality Provider Oversight Lead in Washington, DC. This role focuses on ensuring the integrity and improvement of services delivered to enrollees. Candidates need a BSN and 3-5 years of experience in quality assurance and home health oversight. Responsibilities include conducting quality site visits and collaborating with various departments to enhance care delivery. This position promotes an equal opportunity work environment. #J-18808-Ljbffr

A leading structural heart innovation company seeks a First Shift Associate Inspector in Salt Lake City, UT. This position involves inspecting components and finished medical devices, conducting functional tests, and ensuring compliance with specifications. An H.S. Diploma is required along with English proficiency. The ideal candidate will have strong attention to detail, good communication skills, and the ability to work in a team. This full-time role operates Monday through Thursday with a pay rate of $19.44/hr. #J-18808-Ljbffr

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

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

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

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

Job SummaryResponsible for visually inspecting filled product off the filling line following Standard Operating Procedures Dept. and on the off-line inspection area and therefore must be knowledgeable of procedures and (SOP) and current Good Manufacturing Processes (cGMP). The production inspector will work in the Capping equipment in each area Pay Range: $19.91 - $21.66Responsibilities The Specialist performs some or all of the following accountabilities as assigned: * Visually inspects products for various defects. * Documents work accurately and timely. * Complies with current SOP's and cGMP's. * Sets-up, adjusts, and operates equipment such as inspection machines, cappers, etc. * Performs and documents critical start-up procedures for filling operation such as filter integrity test, line clearance, component verification, etc * Performs and documents quality checks on product. * Calculates percent defective on inspection results and reconciles components on batch record. * Loads and unloads vials from turntables. Stacks, wraps and moves pallets of product. Performs other duties as assigned. Additional Information We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability,401K with company contribution, andwellness program. Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.

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.

Career-defining. Life-changing. At iRhythm, you'll have the opportunity to grow your skills and your career while impacting the lives of people around the world. iRhythm is shaping a future where everyone, everywhere can access the best possible cardiac health solutions. Every day, we collaborate, create, and constantly reimagine what's possible. We think big and move fast, driven by our commitment to put patients first and improve lives. We need builders like you. Curious and innovative problem solvers looking for the chance to meaningfully shape the future of cardiac health, our company, and your career About This Role: The 2nd Shift Quality Control (QC) Inspector is responsible for supporting manufacturing operations during second shift by performing inspection, documentation review, and batch release readiness activities for finished goods and sub-assemblies. This role focuses on reviewing batch records, travelers, and routers, ensuring Good Documentation Practices (GDP) compliance, identifying quality issues, and initiating nonconformances (NCs) when required. The QC Inspector also provides Receiving Inspection (RI) support as needed to ensure material flow continuity and compliance with inspection requirements. Why This Role Is Critical * Provides real-time quality oversight on second shift, ensuring batch records, travelers, and GDP compliance are verified at the time of execution rather than retrospectively. * Enables timely identification and containment of nonconformances, reducing quality escapes, rework, and compliance risk. * Supports on-time release readiness and uninterrupted manufacturing flow, preventing inspection and documentation backlogs into first shift. * Strengthens audit readiness and cross-shift continuity, ensuring clear handoff and sustained control of quality issues across shifts. What You WIll Be Doing Batch Record, Traveler & Router Review * Perform detailed review of batch records and travelers for finished goods and sub-assemblies to ensure completeness, accuracy, and compliance with approved procedures. * Verify that all required manufacturing steps, inspections, testing reports, in-process checks, and approvals are properly completed and documented. * Ensure material traceability, including material lots, subassemblies, equipment identification (when applicable), and inspection status. * Access and reference the electronic Quality Management System (eQMS) to ensure the current, approved revisions of drawings, specifications, procedures, and work instructions are used during inspection and batch record review activities. * Verify that batch records, travelers, and inspection activities are executed against the correct released document revisions, and escalate discrepancies when outdated or incorrect documents are identified * Identify documentation errors, omissions, or discrepancies and ensure timely correction in accordance with GDP requirements. Finished Goods & Sub-Assembly Inspection * Perform in-process, final, or verification inspections of finished goods and sub-assemblies per approved inspection plans and work instructions. * Ensure inspection results are accurately recorded and aligned with acceptance criteria. * Support timely review and release readiness of manufacturing lots to maintain production flow. Nonconformance Identification & Escalation * Identify, document, and initiate Nonconformance (NC) records when inspection results, documentation, or material conditions do not meet requirements. * Ensure nonconforming material is properly identified, labeled, and segregated to prevent unintended use. * Escalate quality issues to Quality Control leadership and Manufacturing supervision as required. Good Documentation Practices (GDP) Compliance * Enforce GDP standards across all reviewed records, including batch records, travelers, routers, and inspection forms. * Ensure corrections, clarifications, and late entries (when applicable) are performed per approved GDP procedures. * Support identification of recurring documentation issues and participate in corrective actions or retraining as needed. Receiving Inspection (RI) Support * Perform Receiving Inspection (RI) activities when required, following approved sampling plans, inspection criteria, and procedures. * Verify material identification, lot traceability, and acceptance status. * Accurately document RI results and communicate material status to Manufacturing and Quality teams. Compliance & Audit Readiness * Perform all activities in compliance with ISO 13485, and internal QMS SOPs, DOP's and work instructions. * Maintain inspection areas and records in a state of audit readiness. * Support internal audits and regulatory inspections by providing accurate records and inspection evidence as requested. Cross-Shift & Cross-Functional Communication * Communicate inspection results, documentation issues, and open quality concerns clearly during shift handoffs. * Collaborate with Manufacturing, Quality Engineering, Receiving, and first-shift QC personnel to ensure continuity of quality controls. What We Want to See * High School Diploma or GED required; Associate's or Bachelor's Degree in a technical or life sciences field is preferred. * Minimum of 2-5 years of experience in a medical device manufacturing, pharma, aerospace or regulated manufacturing environment, preferably in Quality Control or Inspection. * Experience navigating an electronic Quality Management System (eQMS) to review and reference released drawings, specifications, SOPs, and work instructions * Working knowledge of Good Documentation Practices (GDP) and controlled document execution. * Experience reviewing batch records, travelers, routers, and inspection records. * Ability to identify quality issues and initiate nonconformance records in accordance with established procedures. * Strong attention to detail with a focus on accuracy, compliance, and data integrity. * Ability to work independently on second shift with minimal supervision. * Effective verbal and written communication skills. * Ability to manage multiple tasks and prioritize work to support production needs. Ways to Stand Out * Experience performing Receiving Inspection (RI) or FAI activities. * Familiarity with sampling plans, inspection plans, and acceptance criteria. * Demonstrated experience reviewing engineering drawings, including GD&T, to identify critical-to-quality (CTQ) characteristics, specification notes, and applicable inspection requirements, and applying them during inspection and batch record review * Experience using enterprise resource planning (ERP) systems (e.g., QAD, SAP) to support manufacturing execution, batch review, material status, and traceability is a plus Location: Orange County Actual compensation may vary depending on job-related factors including knowledge, skills, experience, and work location. Estimated Pay Range $21.15 - $26.44 As a part of our core values, we ensure an inclusive workforce. We welcome and celebrate people of all backgrounds, experiences, skills, and perspectives. iRhythm Technologies, Inc. is an Equal Opportunity Employer. We will consider for employment all qualified applicants with arrest and conviction records in accordance with all applicable laws. iRhythm provides reasonable accommodations for qualified individuals with disabilities in job application procedures, including those who may have any difficulty using our online system. If you need such an accommodation, you may contact us at ********************* About iRhythm Technologies iRhythm is a leading digital healthcare company that creates trusted solutions that detect, predict, and prevent disease. Combining wearable biosensors and cloud-based data analytics with powerful proprietary algorithms, iRhythm distills data from millions of heartbeats into clinically actionable information. Through a relentless focus on patient care, iRhythm's vision is to deliver better data, better insights, and better health for all. Make iRhythm your path forward. Zio, the heart monitor that changed the game. There have been instances where individuals not associated with iRhythm have impersonated iRhythm employees pretending to be involved in the iRhythm recruiting process, or created postings for positions that do not exist. Please note that all open positions will always be shown here on the iRhythm Careers page, and all communications regarding the application, interview and hiring process will come from a @irhythmtech.com email address. Please check any communications to be sure they come directly from @irhythmtech.com email address. If you believe you have been the victim of an imposter or want to confirm that the person you are communicating with is legitimate, please contact *********************. Written offers of employment will be extended in a formal offer letter from an @irhythmtech.com email address ONLY. For more information, see *********************************************************************************** and *****************************************

Description: 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.

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.

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.

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.

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

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