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Quality Assurance Inspector jobs at Amneal Pharmaceuticals

- 78 jobs
  • QA Inspector, QA

    Hikma Pharmaceuticals 4.9company rating

    Cherry Hill, NJ jobs

    Job Title: QA Inspector ( 3rd Shift) Job Type: Full-Time About Us: As a developer, manufacturer, and supplier of essential medicines, Hikma Pharmaceuticals USA Inc. and its affiliates' purpose is to put better health within reach, every day for millions of patients around the world. We are a trusted, reliable partner and dependable source of over 760 high-quality generic, specialty and branded pharmaceutical products that hospitals, physicians and pharmacists need to treat their patients across North America, the Middle East, North Africa and Europe. Through our global footprint of 30+ manufacturing plants, 8+ R&D centers, and 9,000+ empowered employees, we are committed to making high-quality medicines accessible to the people who need them. Description: We are committed to building a diverse and inclusive team and encourage applications from candidates of all backgrounds. We are seeking a talented and motivated QA Inspector to join our team for monitoring in-process product quality for Filling and Inspection and Packaging of parenteral products. Key Responsibilities: * Regular and predictable onsite attendance and punctuality. * Performs in-coming tasks which include pallet checking, raw material sampling, review of test results, release of components, raw materials and production supplies. * Contacts QA Coordinator or QA Supervisor for daily line assignments. * Samples/Checks/Verifies Controlled Substances during in-coming monitoring and raw material sampling. * Must pass frocking qualification for controlled areas and pass the respirator requirements for sampling raw materials * Samples using analytical instrumentation such as Analytical balances, glove boxes and compressed gases. * Be able to push pallet(s) of raw material with the use of a pallet jack * Maintains good housekeeping and safe working conditions. * Accurately and clearly documents sampling/ inspection/test results in accordance to department and site SOPs. * Performs other duties to support production or validation as determined by QA Supervisor. * Participates in rotation for weekend coverage to support production. May work flexible hours and overtime on a short notice to support production. Qualifications: We value the skills and experiences candidates bring to the table. While we have listed some qualifications below, we encourage candidates to apply even if they do not meet all of them: * Associate's degree in science OR Bachelor's Degree with 0-2 years applicable laboratory, pharmaceutical manufacturing, or related experience. * 0-2-year applicable laboratory or pharmaceutical production experience (QA preferred). * Possesses proficient mathematical skills (addition, subtraction, multiplication, division, algebra, unit conversions, rounding significant figures, dividing polynomials, solving rational equations). * Familiar with cGMPs, EU, CFR and the USP * Demonstrates good attention to detail and accuracy * Good organizational skills and ability to multi-task and perform work in a timely manner * Demonstrates ability to work in a team environment with good communication skills and ability to communicate effectively with peers, department management and production personnel * Knowledge of computer systems at a level proficient to navigate input and/or reference computerized data * Must have sound judgment and demonstrate good analytical skills to assess risk to issues related to the manufacturing process * Must be able to pass the respirator requirements established for the Inspector position * Ability to stand/walk 85% of the shift to sample raw material and deliver to labs * Good manual dexterity to repetitively manipulate syringes to sample filled units for in-process monitoring * Good close visual acuity (eye exam required) * Noise levels on production lines may be moderate to high * Able to lift 15 lbs. * Able to pull/push raw materials with use of a pallet jack. Compensation: Hourly Rate: $20.29 to $ 31.01 per hour. The compensation for this position will be determined during the interview process and will vary based on multiple factors, including, but not limited to, work location, prior experience and job-related knowledge, relevant skills and expertise, current business needs, and market factors. The Talent Acquisition team can provide more details about the specific salary range for the job location during the hiring process. What We Offer*: * Annual performance bonus, commission, and share potential * Auto enrollment in a Hikma-sponsored 401(k) program at a pre-tax contribution rate of 3% of eligible pay. Hikma will match 100% of the first 6% of eligible pay that you contribute * A generous paid time off (PTO) bank starting with 20 days (prorated based on hire date). Additional days granted upon reaching work milestone anniversaries * 3 personal days (prorated based on hire date) * 11 company paid holidays * Comprehensive benefits including health, dental, vision, mental health, disability, life insurance, prescription drug coverage, and a variety of voluntary benefits * Employee discount program * Wellbeing rewards program * Safety and Quality is a top organizational priority * Career advancement and growth opportunities * Tuition reimbursement * Paid maternity and parental leave * Eligibility requirements apply to some benefits and depend on the job classification, role, and length of employment. Benefits are subject to change as well as specific plan or program terms. Recruiters: Please note that Hikma has a set roster of approved recruiters for specific roles agreed to in advance and does not accept unsolicited resumes or calls from third-party recruiters or employment agencies regarding open positions. In the absence of a signed agreement and approval from Hikma's Human Resources department to submit resumes for a specific position, Hikma will not approve, nor will be under an obligation to make, any payment to such non-approved third-parties in the event a candidate they refer is hired by Hikma. Equal Opportunity Employer: Hikma Pharmaceuticals USA Inc. is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status, or other characteristics protected by law. Location: Cherry Hill, NJ, US, 08003 Nearest Major Market: Philadelphia
    $20.3-31 hourly Auto-Apply 30d ago
  • QA Operations Materials Associate

    American Regent 4.7company rating

    New Albany, OH jobs

    Nature and Scope This position is a member of the Quality Assurance team. This position is responsible for ensuring the overall Quality in their assigned areas through the execution of site policies and procedures, programs and work instructions. Ensures all processes and products meet specifications and that products are produced in accordance with GMP requirements. This position is responsible for participating in material receipt, then coordinating sampling and inspection for components, in a sterile manufacturing facility. This position is responsible for ensuring the overall Quality of materials as assigned by Quality Management in coordination with other stakeholders such as Materials Management and Operations, etc. Essential Duties and Responsibilities Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time. Responsible for execution of procedural documentation as they pertain to various aspects of the receiving and sampling processes. Performs sampling of components. Conduct verifications and checks through accurate material inspections. Identify out of specification materials ensuring segregation and escalation, and perform any activities required within the Trackwise Events system Management of BPCS for verification and disposition of materials Maintain retain samples for all primary and secondary components and labeling Performance of DAF (Destruction Approval) process for rejected materials Use of Trackwise and Veeva for change controls, as needed Ensure errors and omissions are resolved according to Standard Operating Procedure (SOP) requirements Ensure all work is performed and documented in accordance with existing Company policies and procedures, as well as cGMP, health and safety requirements. Ensure all components and raw materials are appropriately prepared for the applicable status disposition, including all relevant documentation. Support generation of logbooks and sheets/labels as required. Basic knowledge of cGMPs and supporting regulatory documents Perform room, area and equipment clearances that may be necessary for this job function. Able to perform tasks with minimal error rate. Assist other Quality Assurance Operations Associates, as needed. Perform any other tasks/duties as assigned by management. Education Requirements and 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. High School Diploma or GED equivalent required. Associates or Bachelor's Degree preferred. At least two (2) years of related experience (QA, Compliance, Auditing, Laboratory or Inspection, within a GMP environment) preferred. Must be able to do work independently. Experience in QA working in a cGMP manufacturing environment (preferred) Working knowledge and understanding of quality assurance principles and familiarity with QA programs Strong analytical skills, attention to detail and adherence to procedures. Intermediate skills in Microsoft Word and Excel are required. Excellent organizational, interpersonal and communication skills (written and oral) required. Ability to take feedback constructively and function in a team-oriented work environment. Ability to work overtime as needed. Physical Environment and Requirements Physically able to wear cleanroom/protective gowning and equipment, including but not limited to gowning, goggles, face shields, respirators, and protective gloves. PPE and Respirators are essential for the health and safety of employees. Specific vision requirements include 20/20 near vision (can be corrected with eyeglasses or contacts) and color vision. Employees must maintain a clean-shaven appearance each working shift to wear tight-fitting respirators properly. Employee must be able to occasionally lift and/or move up to 25 pounds. American Regent celebrates diversity and we are committed to creating an inclusive environment for all employees. 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, national origin, disability status, or protected veteran status. Applicants have rights under Federal Employment Laws. FMLA poster: ********************************************************** Know Your Rights: Know Your Rights: Workplace discrimination is illegal (eeoc.gov) Employee Polygraph Protection Act: ********************************************************* Alert: We're aware of individuals impersonating our staff to target job seekers. Please note: · All legitimate communication will come directly from a verified ARI recruiter either by phone or via an americanregent.com email address. · Our recruiting process includes multiple in person and/or video interviews and assessments. · If you are unsure about the legitimacy of a message, contact John Rossini at *************************** before responding. · We never request payment, bank information, or personal financial details during our offer process. Your security is important to us, and we encourage you to stay vigilant when job searching. American Regent Inc. endeavors to make *********************************** accessible to any and all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please email **************************************.
    $48k-68k yearly est. Auto-Apply 60d ago
  • QA Inspector, QA - 3rd Shift

    Hikma Pharmaceuticals USA Inc. 4.9company rating

    Cherry Hill, NJ jobs

    Job Title: QA Inspector, QA - 3rd Shift Job Type: Full-time About Us: As a developer, manufacturer, and supplier of essential medicines, Hikma Pharmaceuticals USA Inc. and its affiliates' purpose is to put better health within reach, every day for millions of patients around the world. We are a trusted, reliable partner and dependable source of over 760 high-quality generic, specialty and branded pharmaceutical products that hospitals, physicians and pharmacists need to treat their patients across North America, the Middle East, North Africa and Europe. Through our global footprint of 30+ manufacturing plants, 8+ R&D centers, and 9,000+ empowered employees, we are committed to making high-quality medicines accessible to the people who need them. Description: We are committed to building a diverse and inclusive team and encourage applications from candidates of all backgrounds. We are seeking a talented and motivated QA Inspector, QA. In this role, you will be responsible for monitoring in-process product quality for Filling and Inspection and Packaging of parenteral products. The QA Inspector is responsible for performing visual and functional testing of product against statistically based sampling plans. In addition, the QA Inspector performs routine inspection and testing of components in accordance with Standard Procedures and specifications as required by production scheduling. In performing the above duties, the individual is responsible for accurately and clearly documenting test results in accordance with cGMPs. This position participates in rotation for weekend coverage and as needed during the work week. Key Responsibilities: Regular and predictable onsite attendance and punctuality. Performs in-coming tasks which include pallet checking, raw material sampling, review of test results, release of components, raw materials and production supplies. Contacts QA Coordinator or QA Supervisor for daily line assignments. Samples/Checks/Verifies Controlled Substances during in-coming monitoring and raw material sampling. Must pass frocking qualification for controlled areas and pass the respirator requirements for sampling raw materials Samples using analytical instrumentation such as Analytical balances, glove boxes and compressed gases. Be able to push pallet(s) of raw material with the use of a pallet jack Be able to lift 15-20 lbs. Maintains good housekeeping and safe working conditions. Accurately and clearly documents sampling/ inspection/test results in accordance to department and site SOPs. Performs other duties to support production or validation as determined by QA Supervisor. Participates in rotation for weekend coverage to support production. May work flexible hours and overtime on a short notice to support production. Qualifications: We value the skills and experiences candidates bring to the table. While we have listed some qualifications below, we encourage candidates to apply even if they do not meet all of them: Associate's degree in science or equivalent with 0-2 year applicable laboratory, pharmaceutical manufacturing or related experience 2-year applicable laboratory or pharmaceutical production experience Possesses proficient mathematical skills (addition, subtraction, multiplication, division, algebra, unit conversions, rounding significant figures, dividing polynomials, solving rational equations). Familiar with cGMPs, EU, CFR and the USP Demonstrates good attention to detail and accuracy Good organizational skills and ability to multi-task and perform work in a timely manner Demonstrates ability to work in a team environment with good communication skills and ability to communicate effectively with peers, department management and production personnel Knowledge of computer systems at a level proficient to navigate input and/or reference computerized data Must have sound judgment and demonstrate good analytical skills to assess risk to issues related to the manufacturing process Must be able to pass the respirator requirements established for the Inspector position Ability to stand/walk 85% of the shift to sample raw material and deliver to labs Good manual dexterity to repetitively manipulate syringes to sample filled units for in-process monitoring Good close visual acuity (eye exam required) Noise levels on production lines may be moderate to high Able to lift 15 lbs Able to pull/push raw materials with use of a pallet jack Preferred Qualifications: Prior QA experience preferred Compensation: Hourly Rate: $26.00 per hour. The compensation for this position will be determined during the interview process and will vary based on multiple factors, including, but not limited to, work location, prior experience and job-related knowledge, relevant skills and expertise, current business needs, and market factors. The Talent Acquisition team can provide more details about the specific salary range for the job location during the hiring process. What We Offer*: Annual performance bonus, commission, and share potential Auto enrollment in a Hikma-sponsored 401(k) program at a pre-tax contribution rate of 3% of eligible pay. Hikma will match 100% of the first 6% of eligible pay that you contribute A generous paid time off (PTO) bank starting with 20 days (prorated based on hire date). Additional days granted upon reaching work milestone anniversaries 3 personal days (prorated based on hire date) 11 company paid holidays Comprehensive benefits including health, dental, vision, mental health, disability, life insurance, prescription drug coverage, and a variety of voluntary benefits Employee discount program Wellbeing rewards program Safety and Quality is a top organizational priority Career advancement and growth opportunities Tuition reimbursement Paid maternity and parental leave *Eligibility requirements apply to some benefits and depend on the job classification, role, and length of employment. Benefits are subject to change as well as specific plan or program terms. Recruiters: Please note that Hikma has a set roster of approved recruiters for specific roles agreed to in advance and does not accept unsolicited resumes or calls from third-party recruiters or employment agencies regarding open positions. In the absence of a signed agreement and approval from Hikma's Human Resources department to submit resumes for a specific position, Hikma will not approve, nor will be under an obligation to make, any payment to such non-approved third-parties in the event a candidate they refer is hired by Hikma. Equal Opportunity Employer: Hikma Pharmaceuticals USA Inc. is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status, or other characteristics protected by law.
    $26 hourly 60d+ ago
  • QA Inspector III - 3rd Shift

    PDI 4.4company rating

    Orangeburg, NY jobs

    Driven by a commitment to research, quality, and service, PDI provides innovative products, educational resources, training, and support to prevent infection transmission and promote health and wellness. Encompassing three areas, our Healthcare, Sani Professional and Contract manufacturing divisions, we develop, manufacture, and distribute leading edge products for North America and the world. We have several locations across the US and are looking for new Associates to join our team! POSITION PURPOSE The Quality Assurance Inspector III ensures that all products manufactured on the production floor meet required quality, regulatory, and customer standards. This role performs daily in-process inspections, testing, documentation review, and line clearances to verify compliance with GMPs and manufacturing specifications. The Inspector collaborates closely with Production and Quality teams to identify discrepancies, support sample collection and rework activities, and assist with trials and validations. As a senior-level inspector, this position also provides oversight and serves as backup to the Lead QA Inspector, ensuring appropriate coverage of inspection activities and supporting coordination of quality tasks across production lines when needed. ESSENTIAL FUNCTIONS AND BASIC DUTIES Perform daily inspection of all production lines to assure compliance to GMPs and company. Accurately and completely document all inspection information on Daily Inspection Report (DIR). Documentation required includes but is not limited to: incoming lot #, liquid lot #, item #s, fill weights, defects, etc. Ensure that all manufacturing specifications for components, labeling and product are correct, clear and complete. Inspect work areas for removal or all previous products and components. Verify readiness of work areas prior to use (Line Clearance). Monitor, sample, and inspect in-process finished product for quality by performing appropriate tests. Collect data and samples to support disposition of product. Determine final disposition of products inspected and verify information on transfer tickets. Apply appropriate disposition label to material. Identify and notify Production and Quality when discrepancies from procedures and specifications are observed. Perform AQL inspections as required. Execute Rework protocols as required. Initiate/Login LIMS and Retain Samples. Print Specifications from AS400, create shop order packages, and provide to Production, as needed. Collect samples as required by customers or Nice Pak/PDI specifications and ship samples to customers, as required by the Manufacturing Instructions. Collect stability samples. Execute Trials and Validations. Review documentation to assure accuracy prior to submittal to QA Release team. Review Master Batch Sheets. Act as Lead QA Inspector in his or her absence to complete distribution of lines and ensure proper coverage of the production floor during the appropriate shift. Identify continuous improvement opportunities and promote a quality culture. Handle assignments as requested by supervision to establish and maintain product quality. Perform any required testing as per SOPs and WIs. PERFORMANCE MEASUREMENTS First time right on review of production jackets On-time completion of all training QUALIFICATIONS EDUCATION/CERTIFICATION: Associate's Degree in a scientific, technical, or related field, or equivalent combination of education and experience. REQUIRED KNOWLEDGE: Strong understanding of Good Manufacturing Practices (GMPs), quality systems, and regulated manufacturing environments. Working knowledge of AQL inspection standards, sampling plans, and in-process quality control methods. Familiarity with batch documentation, manufacturing specifications, and component/label verification. Proficiency in Microsoft Office Suite (Word, Excel, Outlook); ability to learn and operate quality-related systems such as LIMS, ERP, and electronic documentation tools. EXPERIENCE REQUIRED: Minimum 3+ years of experience in a regulated industry (e.g., FDA, EPA, ISO), preferably in manufacturing or quality assurance roles. Demonstrated experience performing in-process quality inspections, line clearances, material disposition, and documentation review. Experience supporting trials, validations, rework activities, and sample collection for customers, retains, or stability programs. Prior exposure to continuous improvement, deviation identification, and collaboration with Production/Quality teams. SKILLS/ABILITIES: Strong ability to interpret and follow SOPs, Work Instructions, Master Batch Records, and product specifications. Excellent documentation accuracy, attention to detail, and commitment to “first-time-right” execution. Ability to conduct inspections, testing, and sampling with a high degree of consistency and objectivity. Effective communication skills with the ability to escalate discrepancies and collaborate across Production, Quality, and other cross-functional teams. Solid organizational, multitasking, and time-management skills to ensure efficient coverage of manufacturing lines. Ability to take initiative, identify improvement opportunities, and support a quality-focused culture. Leadership capability to act as Lead QA Inspector when needed and coordinate inspection coverage on the production floor. Excellent organizational and leadership skills and ability to interact with cross functional teams throughout the organization WORKING CONDITIONS Ability to lift 25 lbs. SALARY RANGE $55,000 - $60,000 annually, plus bonus PDI is pleased to offer a comprehensive and affordable benefits program to our associates, which includes: Medical & prescription drug coverage Dental / Vision plan 401(k) savings plan with company match Basic and supplemental life insurance Flexible Spending Accounts (FSAs) Short- and long-term disability benefits Health Advocacy Program / Employee Assistance Program (EAP) Many other voluntary benefit plans such as: Legal assistance, critical illness, hospital indemnity and accident coverage, discounted home/auto/rental insurance, employee discounts and pet insurance At PDI, we are also committed to helping our associates maintain a healthy and sustainable work/life balance and are proud to provide: Sick leave, generous vacation and holiday time, paid parental leave, summer hours, flex place/flex time options
    $55k-60k yearly 29d ago
  • QA Inspector III - 3rd Shift

    PDI 4.4company rating

    Orangeburg, NY jobs

    Driven by a commitment to research, quality, and service, PDI provides innovative products, educational resources, training, and support to prevent infection transmission and promote health and wellness. Encompassing three areas, our Healthcare, Sani Professional and Contract manufacturing divisions, we develop, manufacture, and distribute leading edge products for North America and the world. We have several locations across the US and are looking for new Associates to join our team! POSITION PURPOSE The Quality Assurance Inspector III ensures that all products manufactured on the production floor meet required quality, regulatory, and customer standards. This role performs daily in-process inspections, testing, documentation review, and line clearances to verify compliance with GMPs and manufacturing specifications. The Inspector collaborates closely with Production and Quality teams to identify discrepancies, support sample collection and rework activities, and assist with trials and validations. As a senior-level inspector, this position also provides oversight and serves as backup to the Lead QA Inspector, ensuring appropriate coverage of inspection activities and supporting coordination of quality tasks across production lines when needed. ESSENTIAL FUNCTIONS AND BASIC DUTIES * Perform daily inspection of all production lines to assure compliance to GMPs and company. Accurately and completely document all inspection information on Daily Inspection Report (DIR). Documentation required includes but is not limited to: incoming lot #, liquid lot #, item #s, fill weights, defects, etc. Ensure that all manufacturing specifications for components, labeling and product are correct, clear and complete. * Inspect work areas for removal or all previous products and components. Verify readiness of work areas prior to use (Line Clearance). * Monitor, sample, and inspect in-process finished product for quality by performing appropriate tests. Collect data and samples to support disposition of product. Determine final disposition of products inspected and verify information on transfer tickets. Apply appropriate disposition label to material. * Identify and notify Production and Quality when discrepancies from procedures and specifications are observed. * Perform AQL inspections as required. * Execute Rework protocols as required. * Initiate/Login LIMS and Retain Samples. * Print Specifications from AS400, create shop order packages, and provide to Production, as needed. * Collect samples as required by customers or Nice Pak/PDI specifications and ship samples to customers, as required by the Manufacturing Instructions. * Collect stability samples. * Execute Trials and Validations. * Review documentation to assure accuracy prior to submittal to QA Release team. * Review Master Batch Sheets. * Act as Lead QA Inspector in his or her absence to complete distribution of lines and ensure proper coverage of the production floor during the appropriate shift. * Identify continuous improvement opportunities and promote a quality culture. * Handle assignments as requested by supervision to establish and maintain product quality. * Perform any required testing as per SOPs and WIs. PERFORMANCE MEASUREMENTS * First time right on review of production jackets * On-time completion of all training QUALIFICATIONS EDUCATION/CERTIFICATION: * Associate's Degree in a scientific, technical, or related field, or equivalent combination of education and experience. REQUIRED KNOWLEDGE: * Strong understanding of Good Manufacturing Practices (GMPs), quality systems, and regulated manufacturing environments. * Working knowledge of AQL inspection standards, sampling plans, and in-process quality control methods. * Familiarity with batch documentation, manufacturing specifications, and component/label verification. * Proficiency in Microsoft Office Suite (Word, Excel, Outlook); ability to learn and operate quality-related systems such as LIMS, ERP, and electronic documentation tools. EXPERIENCE REQUIRED: * Minimum 3+ years of experience in a regulated industry (e.g., FDA, EPA, ISO), preferably in manufacturing or quality assurance roles. * Demonstrated experience performing in-process quality inspections, line clearances, material disposition, and documentation review. * Experience supporting trials, validations, rework activities, and sample collection for customers, retains, or stability programs. * Prior exposure to continuous improvement, deviation identification, and collaboration with Production/Quality teams. SKILLS/ABILITIES: * Strong ability to interpret and follow SOPs, Work Instructions, Master Batch Records, and product specifications. * Excellent documentation accuracy, attention to detail, and commitment to "first-time-right" execution. * Ability to conduct inspections, testing, and sampling with a high degree of consistency and objectivity. * Effective communication skills with the ability to escalate discrepancies and collaborate across Production, Quality, and other cross-functional teams. * Solid organizational, multitasking, and time-management skills to ensure efficient coverage of manufacturing lines. * Ability to take initiative, identify improvement opportunities, and support a quality-focused culture. * Leadership capability to act as Lead QA Inspector when needed and coordinate inspection coverage on the production floor. * Excellent organizational and leadership skills and ability to interact with cross functional teams throughout the organization WORKING CONDITIONS * Ability to lift 25 lbs. SALARY RANGE * $55,000 - $60,000 annually, plus bonus PDI is pleased to offer a comprehensive and affordable benefits program to our associates, which includes: * Medical & prescription drug coverage * Dental / Vision plan * 401(k) savings plan with company match * Basic and supplemental life insurance * Flexible Spending Accounts (FSAs) * Short- and long-term disability benefits * Health Advocacy Program / Employee Assistance Program (EAP) Many other voluntary benefit plans such as: Legal assistance, critical illness, hospital indemnity and accident coverage, discounted home/auto/rental insurance, employee discounts and pet insurance At PDI, we are also committed to helping our associates maintain a healthy and sustainable work/life balance and are proud to provide: Sick leave, generous vacation and holiday time, paid parental leave, summer hours, flex place/flex time options
    $55k-60k yearly 21d ago
  • QA Inspector

    LNK International, Inc. 4.1company rating

    Hauppauge, NY jobs

    Job Description LNK International, Inc. is one of the nation's largest manufacturers of solid and liquid dose, over the counter (OTC) pharmaceuticals. For over 40 years, we have built a reputation for delivering the highest quality products, outstanding service and product innovation. What sets LNK apart? We believe it is our employees. There is a commitment to quality in every department at LNK. As a member of our Accounting department you will be working with dedicated professionals who support and interact with all areas of the company. Our full time employees enjoy competitive benefits including: 401(k) with generous employer match Health Insurance Dental Insurance Paid holidays Paid vacation Responsibilities: Responsibilities include but are not limited to checking the overall quality of the manufacturing and/or packaging operations. Perform all line releases, product quality checks and batch record/work order review. Supports production activities related to the timely production of finished goods. Performs line releases and product quality checks including batch record/work order review for QA release. Assists in the validation/qualification of batches, including sampling. Ensure that any required sampling is performed and samples are submitted to laboratory. Maintain records and organize documents to support packaging/manufacturing operations in an efficient manner. Assist when needed for any pertinent investigations involving respective areas. Monitor warehousing and staging areas to ensure materials are being received/shipped/maintained within cGMP and SOP Guidelines. Report building maintenance issues to ensure compliance with AIB, HACCP, cGMP regulations and pertinent SOP's and report them to the QA Supervisor. Assist in the monitoring and maintenance of the Pest control, calibration and temperature monitoring programs. All other duties as assigned Education and Experience: HS Diploma At least one year of directly related experience. Work Environment: In person. There is no remote option for this role. Overtime may be required from time to time. The salary listed is a good faith determination of potential base compensation that may be offered to a successful applicant for this position at the time of this job advertisement and may be modified in the future. When determining a team member's base salary and/or rate, several factors may be considered as permitted by law. LNK provides equal employment opportunities to all applicants and prohibits discrimination of any type on the basis of actual or perceived race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender (including pregnancy, childbirth and pregnancy-related conditions), gender identity or expression (including transgender status), sexual orientation, marital status, military service and veteran status, physical or mental disability, genetic information or any other characteristic protected by applicable federal, state or local laws. Job Posted by ApplicantPro
    $34k-55k yearly est. 2d ago
  • Quality Assurance Tech

    PL Developments Careers 4.6company rating

    Lynwood, CA jobs

    PL Developments, also known as PLD, is a leading manufacturer, packager, and distributor of over-the-counter (OTC) pharmaceutical products and consumer healthcare goods. The Quality Assurance Technician is responsible for ensuring that products or services consistently meet defined quality standards and customer requirements. They perform inspections, tests, and evaluations to identify and resolve quality issues, contributing to the overall quality of the production process. JOB QUALIFICATIONS: High School Diploma or equivalent required 2-5 years of experience in related field Knowledge of FDA/cGMP guidelines, 21 CFR Parts 111, 210 & 211 preferred Highly organized and strong attention to detail Time management skills and ability to handle multiple tasks on time Excellent oral and written communication skills in English Proficient in Word and Excel Working knowledge of Oracle and Agile preferred Experience with Warehouse Management Systems (WMS) Must be able to drive a forklift, training offered POSITION RESPONSIBILITIES: Manage receiving inspection of all critical components and raw materials Manage and support JIT program Review and report all documentation from shipments prior to release in Oracle Manage NCMR and RMA programs and oversee trailer loading or products slated for destruction Manage physical inventory in NCMR and Quality Cages Write and Review CRNs/NCMRs/CAPA/Investigations/Deviations as needed Maintain the retains program and storage of retains Perform and manage annual review of Finished Good retains Generate reports to look for trends in inspections Suggest solutions to management for trends when required Work with cross-functional departments Assist with investigations as requested QA inquiries from other sites or vendors Train the team on processes as needed Assist Quality Management as needed Physical Requirements: Walking up to 6 hours per day Sitting up to 2 hours per day Occasionally lift up to 30 lbs. Salary Range: $21.50-$22.50/hr BENEFITS: PLD is a proud employer offering many corporate benefits, including: ⠁ Medical and Dental Benefits ⠁ Vision ⠁ 401K with employer match ⠁ Group Life Insurance ⠁ Flex Spending Accounts ⠁ Paid Time Off and Paid Holidays ⠁ Tuition Assistance ⠁ Corporate Discount Program ⠁ Opportunities to Flourish Within the Company PL Developments is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.
    $21.5-22.5 hourly 60d+ ago
  • Inspector; QA Manufacturing - 3rd Shift (11:00PM - 7:30AM)

    Contract Pharmacal Corp 4.3company rating

    Hauppauge, NY jobs

    Job DescriptionDescription: The Inspector, QA Manufacturing has the primary responsibility of ensuring product quality is maintained through all phases of manufacturing in accordance with current good manufacturing practices. Responsibilities: Responsibilities include, but are not limited to: Perform in-process monitoring (e.g. weight, thickness, hardness, disintegration, friability, etc.) of all manufacturing operations Perform duties using good documentation practices Collect in-process and finished product samples as required Support collection of microbiological samples per procedure as required Perform room inspections/clearances as required Perform Batch Record release of both Commercial and IP batch records Perform AQL sampling and inspections as required Identify and report any non-conformances/discrepancies to management if applicable Review general SOPs are being met by production Assist in employee training (initial and ongoing) Support environmental monitoring activities (i.e. water sampling air sampling) Provide additional QA technical support to Coating Department Review batch record documentation QMS form issuance as required to production Daily scale weight verification Maintain QA supplies Review and approve weekly pest control logs Sample transmittal to QC and Account Services Review grounds logbook for Maintenance Monthly audit of facility fire extinguishers Other responsibilities as assigned by Senior Management Requirements: Education and Experience: High School or GED diploma required Knowledge of good manufacturing practices and good documentation practices preferred. Skills, Knowledge and Abilities: Ability to read, write, and communicate effectively. Self-motivated with the ability to work in fast-paced environment and handle multiple tasks simultaneously. Excellent organizational skills with ability to focus on details. Physical Demands: Required to reach with arms and use hands and fingers to handle or feel objects and tools Required to stoop, kneel, crouch, stand, bend, sit, talk, hear, climb stairs and ladders Must be able to lift and/or move up to 50 pounds Work Environment: Work environment in production operations facilities include close proximity to heavy machinery with loud noises and pharmaceutical powders (dust). Potential to move between production operations sites/areas to complete job functions. Employee work hours/schedule and/or shift are subject to change based on business needs and Management discretion. Work location are subject to change as needed to meet business requirements. Supervisory Responsibilities: None Personal Protective Equipment or Attire Required for Position: Gowning as required by GMPs and/or SOPs PPE as needed Pay Range: $23.00 per hour
    $23 hourly 20d ago
  • QA Inspector I - 2nd Shift

    PDI 4.4company rating

    Orangeburg, NY jobs

    Driven by a commitment to research, quality, and service, PDI provides innovative products, educational resources, training, and support to prevent infection transmission and promote health and wellness. Encompassing three areas, our Healthcare, Sani Professional and Contract manufacturing divisions, we develop, manufacture, and distribute leading edge products for North America and the world. We have several locations across the US and are looking for new Associates to join our team! POSITION PURPOSE **This position is for 2nd Shift (M-F, 3:00 pm-11:30 pm)** Quality Assurance Inspector responsible for day-to-day in process quality checks across manufacturing lines to ensure all Finished Goods meet product specifications ESSENTIAL FUNCTIONS AND BASIC DUTIES Perform daily inspection of all production lines to assure compliance to GMPs and company. Accurately and completely document all inspection information on Daily Inspection Report (DIR). Documentation required includes but is not limited to: incoming lot #, liquid lot #, item #s, fill weights, defects, etc. Ensure that all manufacturing specifications for components, labeling and product are correct, clear and complete. Inspect work areas for removal or all previous products and components. Verify readiness of work areas prior to use (Line Clearance). Monitor, sample, and inspect in-process finished product for quality by performing appropriate tests. Collect data and samples to support disposition of product. Determine final disposition of products inspected and verify information on transfer tickets. Apply appropriate disposition label to material. Identify and notify Production and Quality when discrepancies from procedures and specifications are observed. Collect samples as required by customers or Nice Pak/PDI specifications. Review documentation to assure accuracy prior to submittal to QA Release team. Review Master Batch Sheets. Identify continuous improvement opportunities and promote a quality culture. Handle assignments as requested by supervision to establish and maintain product quality. Perform any required testing as per SOPs and WIs. PERFORMANCE MEASUREMENTS First time right on review of production jackets On-time completion of all training QUALIFICATIONS EDUCATION/CERTIFICATION: Associate's Degree or equivalent related experience REQUIRED KNOWLEDGE: Proficiency in Microsoft Office Suite EXPERIENCE REQUIRED: 0-1 Years of experience working in regulated industry SKILLS/ABILITIES: Excellent organizational skills and ability to interact with cross-functional teams throughout the organization WORKING CONDITIONS Ability to lift 25LBs SALARY RANGE $42,000 - $47,000 annually, plus bonus PDI is pleased to offer a comprehensive and affordable benefits program to our associates, which includes: Medical & prescription drug coverage Dental / Vision plan 401(k) savings plan with company match Basic and supplemental life insurance Flexible Spending Accounts (FSAs) Short- and long-term disability benefits Health Advocacy Program / Employee Assistance Program (EAP) Many other voluntary benefit plans such as: Legal assistance, critical illness, hospital indemnity and accident coverage, discounted home/auto/rental insurance, employee discounts and pet insurance At PDI, we are also committed to helping our associates maintain a healthy and sustainable work/life balance and are proud to provide: Sick leave, generous vacation and holiday time, paid parental leave, summer hours and more
    $42k-47k yearly 23d ago
  • Inspector; QA Manufacturing - 2nd Shift (4:15PM - 12:45AM)

    Contract Pharmacal Corp 4.3company rating

    Hauppauge, NY jobs

    Job DescriptionDescription: The Inspector, QA Manufacturing has the primary responsibility of ensuring product quality is maintained through all phases of manufacturing in accordance with current good manufacturing practices. Responsibilities: Responsibilities include, but are not limited to: Perform in-process monitoring (e.g. weight, thickness, hardness, disintegration, friability, etc.) of all manufacturing operations Perform duties using good documentation practices Collect in-process and finished product samples as required Support collection of microbiological samples per procedure as required Perform room inspections/clearances as required Perform Batch Record release of both Commercial and IP batch records Perform AQL sampling and inspections as required Identify and report any non-conformances/discrepancies to management if applicable Review general SOPs are being met by production Assist in employee training (initial and ongoing) Support environmental monitoring activities (i.e. water sampling air sampling) Provide additional QA technical support to Coating Department Review batch record documentation QMS form issuance as required to production Daily scale weight verification Maintain QA supplies Review and approve weekly pest control logs Sample transmittal to QC and Account Services Review grounds logbook for Maintenance Monthly audit of facility fire extinguishers Other responsibilities as assigned by Senior Management Requirements: Education and Experience: High School or GED diploma required Knowledge of good manufacturing practices and good documentation practices preferred. Skills, Knowledge and Abilities: Ability to read, write, and communicate effectively. Self-motivated with the ability to work in fast-paced environment and handle multiple tasks simultaneously. Excellent organizational skills with ability to focus on details. Physical Demands: Required to reach with arms and use hands and fingers to handle or feel objects and tools Required to stoop, kneel, crouch, stand, bend, sit, talk, hear, climb stairs and ladders Must be able to lift and/or move up to 50 pounds Work Environment: Work environment in production operations facilities include close proximity to heavy machinery with loud noises and pharmaceutical powders (dust). Potential to move between production operations sites/areas to complete job functions. Employee work hours/schedule and/or shift are subject to change based on business needs and Management discretion. Work location are subject to change as needed to meet business requirements. Supervisory Responsibilities: None Personal Protective Equipment or Attire Required for Position: Gowning as required by GMPs and/or SOPs PPE as needed Pay Range: $21.50 per hour
    $21.5 hourly 21d ago
  • Quality Assurance (QA) Associate

    Medpace 4.5company rating

    Cincinnati, OH jobs

    The successful candidate will be responsible for facilitating the management of sponsor audits, broad range of regulatory inspections (FDA, EMA, MHRA) and facilitating QA relationship with external clients. The position will also include conducting inspection readiness activities for Medpace and Medpace stakeholders. Responsibilities * Facilitating Medpace sponsor audits onsite; * Review and assess responses to sponsor audit reports; * Provide clarity to the Quality Management System (QMS) during sponsor audits and other external audits; * Provide guidance to Medpace study teams during sponsor audits; * Manage pre-inspection activities for Medpace inspections; * Provide inspection data trends to the Quality Metrics group for executive management review; * Manage the inspection backroom during regulatory inspections to facilitate the timely delivery of requested documents; * Conduct mock interviews for subject matter experts (SMEs) during inspection preparation; * Reviewing, and analyzing regulatory inspection data issued by regulatory authorities (e.g. MHRA, EMA, FDA); * Manage training for Medpace stakeholders with respect to inspection readiness; * Conducting inspection readiness visits at selected sites (as applicable) to assess inspection risk; * Act as QA lead for inspections at Medpace; * Provide as needed support for inspections at Medpace external clients (sponsors and investigator sites); and * Maintain the memorializing of frequently asked questions repository for regulatory inspection. Qualifications * Bachelor's degree in science or a related field; * Experience in conducting and supporting regulatory inspections is a plus (FDA, MHRA and EMA); * Strong communication skills; * Strong quality mindset; * Experience in supporting or conducting audits; * Excellent written and verbal communications skills in English; * Independent thinking and planning ability; * Experience with a wide range of computerized systems; * Good time management skills; * Ability to switch between both big picture view and attention to detail; and * The ability to work well on a team as well as independently. Medpace Overview Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 5,000 people across 40+ countries. Why Medpace? People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today. The work we've done over the past 30+ years has positively impacted the lives of countless patients and families who face hundreds of diseases across all key therapeutic areas. The work we do today will improve the lives of people living with illness and disease in the future. Cincinnati Perks * Cincinnati Campus Overview * Flexible work environment * Competitive PTO packages, starting at 20+ days * Competitive compensation and benefits package * Company-sponsored employee appreciation events * Employee health and wellness initiatives * Community involvement with local nonprofit organizations * Discounts on local sports games, fitness gyms and attractions * Modern, ecofriendly campus with an on-site fitness center * Structured career paths with opportunities for professional growth * Discounted tuition for UC online programs Awards * Named a Top Workplace in 2024 by The Cincinnati Enquirer * Recognized by Forbes as one of America's Most Successful Midsize Companies in 2021, 2022, 2023 and 2024 * Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility What to Expect Next A Medpace team member will review your qualifications and, if interested, you will be contacted with details for next steps.
    $48k-69k yearly est. Auto-Apply 24d ago
  • Laboratory Quality Assurance (QA) Associate

    Medpace 4.5company rating

    Cincinnati, OH jobs

    The successful candidate will be responsible for facilitating the management of sponsor audits, and facilitating QA relationship with external clients. The position will also include conducting inspection readiness activities for Medpace and Medpace stakeholders. Responsibilities * Facilitating Medpace sponsor audits onsite; * Review and assess responses to sponsor audit reports; * Provide clarity to the Quality Management System (QMS) during sponsor audits and other external audits; * Provide guidance to Medpace study teams during sponsor audits; and * Manage pre-inspection activities for Medpace inspections. Qualifications * Bachelor's degree in life science or a related field; * Experience in conducting and supporting regulatory inspections is a plus (FDA, MHRA and EMA); * Strong communication skills; * Strong quality mindset; * Excellent written and verbal communications skills; * Independent thinking and planning ability; * Experience with a wide range of computerized systems; * Good time management skills; * Ability to switch between both big picture view and attention to detail; * The ability to work well on a team as well as independently. Medpace Overview Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 5,000 people across 40+ countries. Why Medpace? People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today. The work we've done over the past 30+ years has positively impacted the lives of countless patients and families who face hundreds of diseases across all key therapeutic areas. The work we do today will improve the lives of people living with illness and disease in the future. Cincinnati Perks * Cincinnati Campus Overview * Flexible work environment * Competitive PTO packages, starting at 20+ days * Competitive compensation and benefits package * Company-sponsored employee appreciation events * Employee health and wellness initiatives * Community involvement with local nonprofit organizations * Discounts on local sports games, fitness gyms and attractions * Modern, ecofriendly campus with an on-site fitness center * Structured career paths with opportunities for professional growth * Discounted tuition for UC online programs Awards * Named a Top Workplace in 2024 by The Cincinnati Enquirer * Recognized by Forbes as one of America's Most Successful Midsize Companies in 2021, 2022, 2023 and 2024 * Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility What to Expect Next A Medpace team member will review your qualifications and, if interested, you will be contacted with details for next steps.
    $48k-69k yearly est. Auto-Apply 60d+ ago
  • Quality Assurance Coordinator

    Eurofins Scientific 4.4company rating

    Azusa, CA jobs

    Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins works with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate. Eurofins is the global leader in food, environment, pharmaceutical and cosmetic product testing and in agroscience Contract Research Organisation services. Eurofins is one of the market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, advanced material sciences and in the support of clinical studies, as well as having an emerging global presence in Contract Development and Manufacturing Organisations. The Group also has a rapidly developing presence in highly specialised and molecular clinical diagnostic testing and in-vitro diagnostic products. In over just 30 years, Eurofins has grown from one laboratory in Nantes, France to 55,000 staff across a decentralised and entrepreneurial network of 900 laboratories in over 50 countries. Eurofins offers a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products. Job Description The Laboratory Quality Assurance (QA) Coordinator is responsible for ensuring that DPT's quality system is well-documented, traceable, and compliant. This role focuses specifically on regulatory readiness documentation and inspection support. Role is critical in tracking, organizing, and executing the administrative an procedural backbone of the laboratories' quality program.. This position ensures compliance with federal, state, and local regulations (e.g., CLIA, CAP, ISO, FDA) and drives continuous quality improvement initiatives. The QA Coordinator develops and maintains policies, conducts audits, manages documentation, and trains staff on quality procedures. Key Responsibilities: * Quality Management System (QMS) Oversight: Develops, implements, and maintains the laboratory's comprehensive quality management system, including the Quality Manual, policies, and procedures. * Regulatory Compliance: Monitor and ensure continuous compliance with all applicable accreditation and regulatory standards (e.g., CAP, CLIA, ISO 15189, GxP, FDA). * Audits and Inspections: Coordinate and participate in internal and external audits/inspections, manage the response to findings, and implement corrective and preventive actions (CAPAs). Assist in preparing audit schedules and checklists. Track corrective actions and verify closures. Organize and maintain documentation needed for audits and inspections. Assist in preparing materials and responses for regulatory and accrediting inspections and client audits. * Documentation and Record Control: Oversees the documentation control system.. Logs and tracks nonconformances, deviations and incident reports. Ensures completeness and accuracy of quality records. * Change Management Support: Log and monitor change requests. Track approval workflows and implementation timelines. Assist in collecting / reminding of required objective evidence for activity / file closure. Ensure related documentation is complete before closure. * Training and Education: Develop and conduct training sessions for staff on quality standards, new procedures, and best practices to promote a quality culture. Send reminders for upcoming and overdue training, as applicable. * Event and Risk Management: Assist in investigation of non-conformances, errors, and incidents; perform root cause analysis; and determine corrective actions to mitigate future risks. Ensure timeliness of all activities to meet regulatory expectations. Develop tools to assist with tracking activities / actions. * Communication and Coordination: Schedule QA Meetings and take meeting minutes. Communicate deadlines, updates and quality-related notifications. Serve as liaison between QA and other departments. * Supplier Qualification Program: Develop schedule to ensure Approved Supplier List (ASL) is kept up-to-date. Ensure qualification / re-qualification documentation is current and filed appropriately. Participate in vendor-related SCAR issuance, receipt of responses and assuring documentation meets DPT's requirements. Qualifications Required Qualifications and Skills: * Education: Bachelor's degree, preferably in a chemical, physical, biological science, or Medical Laboratory Science (MLS/MT) from an accredited institution. * Experience: Minimum of 5-7 years of experience in a clinical or analytical laboratory environment, with demonstrated experience in quality assurance or quality control. * Knowledge: Strong knowledge of quality management systems (e.g., ISO, CLIA, CAP) and relevant federal/state regulations. * Skills: * Excellent attention to detail and strong organizational skills. * Strong analytical and problem-solving abilities, with an aptitude for data interpretation and statistical analysis. * Excellent written and verbal communication skills, with the ability to effectively communicate with diverse staff and management. * Proficiency with laboratory information management systems (LIMS) and Microsoft Office Suite. * Ability to work both independently and collaboratively in a fast-paced environment. Preferred Qualifications: * Certification in quality management (e.g., Certified Quality Auditor (CQA) or Six Sigma certification). * Experience with specific laboratory certifications/standards relevant to the lab's specialty (e.g., ASHI, CAP, CLIA,) Additional Information Compensation: * $75,000 - $100,000 Schedule: * Monday - Friday 8:00am-4:30pm What we offer: * Excellent full time benefits including comprehensive medical coverage, dental, and vision options * Life and disability insurance * 401(k) with company match * Paid vacation and holidays Eurofins USA Clinical Diagnostics is a Disabled and Veteran Equal Employment Opportunity employer.
    $75k-100k yearly 32d ago
  • QC Inspector II

    Arthrex, Inc. 4.8company rating

    Santa Barbara, CA jobs

    Requisition ID: 64222 Title: QC Inspector II Division: Arthrex California Inc (US03) Location: Santa Barbara, CA Salary Range: Salary Minimum: $21.86 Salary Maximum: $30.78 Arthrex, Inc. is a global medical device company and a leader in new product development and medical education in orthopedics. Arthrex is actively searching for a QC Inspector II for our Santa Barbara, CA facility. The QC Inspector II performs a variety of quality control test and inspection functions on materials, components and finished goods at various stages of the production process and compiles and evaluates statistical data to determine and maintain quality and reliability of products. Join our talented team at a global medical device company focused on Helping Surgeons Treat Their Patients Better. Essential Duties and Responsibilities: * Performs and documents dimensional inspections on inventory parts using engineering prints, Inspection procedures or work instructions. * Selects products for tests at specified stages in production process, and tests products for variety of qualities, such as dimensions, performance, and mechanical, electrical, or chemical characteristics. * Records test data, applying statistical quality control procedures. * May perform, as needed, nondestructive tests on materials, parts, or products to measure performance, life, or material characteristics. * May specialize in particular area of quality control such as incoming material, process control, product evaluation, and final inspection. * Detects nonconformances during production operations effectively. * May prepare graphs or charts of data or enter data into computer for analysis. * May perform quality control equipment calibrations and records the data as required. * Generates nonconformance reports as required and follows Inspection procedures. * Recommends modifications of existing quality or production standards to achieve optimum quality within limits of equipment capability. * Evaluates data to indicate deviations from existing standards. * Mostly works unsupervised. Education and Experience: * High School diploma or equivalent required * 1 years of QC or related industry experience required Knowledge and Skill Requirements/Specialized Courses and/or Training: Ability to interpret and understand engineering prints and the ability to use measuring tools and devices. Must have mechanical aptitude and be detail oriented. Machine, Tools, and/or Equipment Skills: Measuring and test equipment, PC and spreadsheets. 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. Deal with several abstract and concrete variables. Mathematical Skills Ability to comprehend and apply mathematical principles to the degree required to perform the job based upon job requirements. Language and Communication Skills: Ability to comprehend and apply language skills to the degree required to perform the job based upon the job requirements listed above. Ability to verbally communicate ideas and issues effectively to other team members and management. Ability to write and record data and information as required by procedures. 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 the job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to talk or hear. The employee is frequently required sit; use hands and fingers, to handle, or feel; and reach with hands and arms. The employee will regularly lift and/or move up to 25 pounds. Vision Requirements: Visual acuity is necessary to do the job safely and effectively. Specific vision abilities required by this job include close vision work with the aid of a microscope and light source. 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 occasionally exposed to moving mechanical parts, fumes or airborne particles, toxic or caustic chemicals, and risk of electrical shock. The noise level in the work environment is usually moderate. Arthrex Benefits * Medical, Dental and Vision Insurance * Company-Provided Life Insurance * Voluntary Life Insurance * Flexible Spending Account (FSA) * Supplemental Insurance Plans (Accident, Cancer, Hospital, Critical Illness) * Matching 401(k) Retirement Plan * Annual Bonus * Wellness Incentive Program * Free Onsite Lunch * Gym Reimbursement Program * Tuition Reimbursement Program * Trip of a Lifetime * Paid Parental Leave * Paid Time Off * Paid Sick Leave * Volunteer PTO * Employee Assistance Provider (EAP) All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other status protected by law. Making People Better at Arthrex Lorem ipsum dolor sit amet consectetur. Cras fringilla elementum odio velit. Job Details Date: Nov 20, 2025 Requisition ID: 64222 Salary Range: Job title: QC Inspector II Arthrex Location: Santa Barbara, CA, US, 93111 Nearest Major Market: Santa Barbara Nearest Secondary Market: Santa Maria Job Segment: Quality Control Inspector, QC, Inspector, Facilities, Quality Assurance, Quality, Operations, Technology
    $21.9-30.8 hourly 52d ago
  • Quality Inspector III

    All Pro Recruiting 4.4company rating

    Willoughby, OH jobs

    Job Description Level 3 Quality Inspector Department: Quality Control Reports To: Quality Manager Employment Type: Full-Time, 1st Shift Compensation: $27.00 - $36.00 per hour (based on experience) Position Summary The Level 3 Quality Inspector ensures all machined components meet customer, drawing, and regulatory requirements throughout the manufacturing process. This position plays a critical role in inspection, process validation, and metrology, operating advanced measurement equipment such as Hexagon CMMs and Keyence Vision Systems. This individual will perform setup validations, in-process audits, and final inspections, as well as support training, documentation, and continuous improvement activities across the quality system. The role offers the opportunity to develop advanced Keyence programming skills through company-provided training for the right candidate. Key Responsibilities · Perform production setup validation utilizing the First Piece Inspection process for each production run. · Conduct in-process inspections and audits on each shift to monitor key part characteristics and process consistency. · Perform final inspection and lot validation according to established sampling plans, verifying dimensional features per the inspection process plan. · Operate Hexagon CMMs with precision and efficiency: load PC-DMIS programs, set up workholding, execute inspections, verify probe calibration, and interpret results. · Complete minor CMM program edits and escalate complex programming issues as needed. · Create and edit Keyence inspection programs for dimensional and visual inspections (training provided if needed). · Train machine operators on the use of Keyence inspection tool and general inspection tools and methods (~5% of work time). · Complete First Article Inspection Reports (FAIRs) for new parts per customer and AS9100 requirements. · Utilize and interpret Process Flow Maps, Control Plans, PFMEAs, and Inspection Process Plans. · Apply advanced GD&T knowledge to interpret datums, feature relationships, and tolerance schemes. · Perform internal audits, report findings, and support corrective actions. · Initiate and assist with internal and external Non-Conformance Reports (NCRs). · Support gage calibration processes and maintain measurement traceability. · Draft and submit FAIRs, NCRs, and Corrective Action Reports for management review. · Participate in continuous improvement projects to strengthen process capability and inspection reliability. Qualifications Required: · Minimum 5 years of experience in dimensional inspection or quality control within a precision machining or aerospace environment. · Strong working knowledge of AS9100 and ISO 9001 quality system requirements. · Proficiency in GD&T interpretation and use of precision measuring instruments. · Hands-on experience operating Hexagon CMMs (PC-DMIS) and performing minor program edits. · Ability to interpret engineering drawings, control plans, and inspection documentation. · Demonstrated ability to complete FAIRs, NCRs, and related quality documentation accurately. · Excellent attention to detail and ability to work independently in a precision-driven environment. Preferred: · 7-10 years of experience in dimensional inspection or quality control within a precision machining or aerospace environment. · Prior Keyence programming experience (IM, XM, or VR systems) or willingness to complete Keyence training to achieve proficiency. · Experience supporting PPAP or APQP documentation. · Previous involvement in internal auditing under AS9100 standards. · Working knowledge of gage calibration systems and traceability management. · Completion of customer-specific quality certifications. Work Environment • Full-time 1st shift position (Monday - Friday). • Climate-controlled inspection lab and shop floor environment. • Occasional overtime and cross-functional collaboration with Production, Engineering, and Quality teams. Compensation & Benefits • Hourly Rate: $27.00 - $36.00, commensurate with qualified experience • Comprehensive benefits package including: - Health & voluntary dental and vision insurance - 401(k) plan with company match - Paid time off and holidays - Ongoing training and advancement opportunities · Be part of a company that builds mission-critical aerospace components with uncompromising precision. · Work in a culture of teamwork, accountability, and continuous improvement. · Develop new technical skills to support and advance quality control initiatives including Keyence inspection programming and other vision inspection systems. · Contribute directly to Rimeco's reputation for quality excellence and customer satisfaction.
    $27-36 hourly 25d ago
  • Quality Assurance Coordinator

    Turning Point Community Programs 4.2company rating

    Chico, CA jobs

    Turning Point Community Programs is seeking a Quality Assurance Coordinator for our Transition Support Services (TSS) North program in Chico. Turning Point Community Programs (TPCP) provides integrated, cost-effective mental health services, employment and housing for adults, children and their families that promote recovery, independence and self-sufficiency. We are committed to innovative and high quality services that assist adults and children with psychiatric, emotional and/or developmental disabilities in achieving their goals. Turning Point Community Programs (TPCP) has offered a path to mental health and recovery since 1976. We help people in our community every single day - creating a better space for all types of people in need. Join our mission of offering hope, respect and support to our clients on their journey to mental health and wellness. GENERAL PURPOSE Under the administrative supervision of the Clinical Director, this position is responsible for ensuring that the program remains in compliance with Regional Center guidelines. Assists the Clinical Director in the quality management functioning of the Program. DISTINGUISHING CHARACTERISTICS This is an at-will administrative position within a program. Additionally, this position is responsible for the day-to-day completion of critical paperwork and assisting the Clinical Director. ESSENTIAL DUTIES AND RESPONSIBILITIES - (ILLUSTRATIVE ONLY) The duties listed below are intended only as illustrations of the various types of work that could be performed. The omission of specific statements of duties does not exclude them from the position if the work is similar, related or a logical assignment to this class Completes Diagnosis updates as assigned. Completes MORS/8 Determinants assessments as assigned. Tracks progress notes and provides feedback directly to management team. Tracks assessments due and completion. Works in coordination with the Team Leaders and Clinical Director to ensure that all assessments and client plans are completed in a timely manner. Attends/Conducts Utilization Review meetings when the Clinical Director is not available. Coordinates with Clinical Director to implement recommendations. Responsible for tracking and reviewing results of internal utilization and review. Reviews charts to ensure that they meet state and legal/Regional Center requirements. Assists the Clinical Director and Program Director with developing the Quality Improvement plan and implementing changes. Assist the Clinical Director with filing, organizing and maintaining a record of KETs (Key Event Tracking) and inputting data into charted system. Assist the Clinical Director with filing, organizing and maintaining a record of Risk Management Binder (SIRs). In coordination with the Clinical Director and Program Director, reviews and evaluates customer satisfaction/performance outcome data. Ensures the safety, health, and well-being of the members. Completes paperwork as assigned in a timely manner. Meets the standards set for performance in all aspects of job duties. Provides support to other staff members as needed. Adheres to and upholds the policies and procedures of Turning Point Community Programs. Attends staff meetings unless approval for non-attendance is secured from the Clinical Director or Program Director. Schedule: Monday - Friday, 8:30 am - 5:00 pm Compensation: $26.00 - $27.59 per hour Interested? Join us at our open interviews on Wednesdays from 2-4PM, located at 10850 Gold Center Drive, Suite 325, Rancho Cordova, CA 95670 -or- CLICK HERE TO APPLY NOW!
    $26-27.6 hourly 60d+ ago
  • Quality Control Inspector

    Precision Optics Corporation 3.9company rating

    Gardner, MA jobs

    Full-time Description The Quality Control Inspector, reporting to the Quality Control Supervisor is responsible for all aspects of incoming, in-process, and final inspections, including measurements, recordkeeping, calibration, documentation, production support on an as needed basis and other urgent matters for the Quality Control Department. Principal Responsibilities Perform dimensional and visual first article and in-process/final inspection on raw material, parts, gages, and other equipment, accepting material/product or referring for quality review based on findings. Prepare inspection reports; ensure material traceability. Initiate Nonconformances (NCR) and Supplier Corrective Action Reports (SCARs); facilitate Material Review Board (MRB) meetings. Use a variety of fixed and variable measuring instruments. Monitor and coordinate Engineering Change Order (ECO) activity across the organization ensuring compliance with the Quality Management System (QMS); support QMS maintenance for compliance with FDA QSR, ISO 13485, and other regulatory requirements. Ensure compliance with electronic document control workflows in QCBD or similar document control tool. Ensure documents are being filed and organized. Support audits in the role as a “Runner”, extracting documents, review them to ensure regulatory compliance and correctness, and present to the Lead Auditor for presentation. Coordinate QA/QC tasks with cross functional teams across the organization: support production and product development teams; review Device History Records (DHRs) for completeness and accuracy; execute receiving procedures & support shipping activities. Support and promote continuous improvement initiatives to meet business objectives. Maintains a safe and healthy work environment by following standards and procedures and complying with legal regulations. Perform miscellaneous duties and projects as assigned and required. Requirements Training, Skills, Knowledge and/or Experience Minimum 1 year of experience performing mechanical inspections in a manufacturing environment; optical inspection experience preferred. Experience working in medical devices and FDA QSR and ISO 13485 preferred. Understanding quality control processes, methods, and standards. Proficiency with Microsoft 365 apps suite. Competencies Strong data collection & analysis, problem solving, presentation and communication skills. Strong attention to detail. Ability to collaborate effectively with cross-functional teams. Education Requirements High School Diploma or GED required. Supervisory Responsibility None Working Conditions This job operates in manufacturing and engineering laboratory environments including ISO class 7 cleanrooms. PPE required when in controlled environment rooms or cleanrooms. Physical surroundings This role routinely uses standard office equipment such as computers, phones, photocopiers, and filing cabinets. Physical Effort While performing duties of this job, the employee is occasionally required to stand, walk, sit, use hands to finger, handle, or feel objects, tools, or controls; reach with hands and arms; talk and hear. Work Schedule / Travel In-person, Mon to Fri in Gardner, MA; occasional travel, with periodic presence in the Windham, ME site. Other Requirements This position involves access to technology that is subject to U.S. export controls. Any job offer made will be contingent upon the applicant's capacity to serve in compliance with U.S. export controls.
    $32k-51k yearly est. 60d+ ago
  • QC Inspector

    Zoetis 4.9company rating

    Union City, CA jobs

    Duties and Responsibilities: Perform inspections of purchased parts according to acceptance criteria using standard sampling plan. Able to perform First Article Inspection (FAI) of manufactured parts, electromechanical assemblies and final assemblies. Physical, mechanical and/or electrical measurements in compliance with the company Quality System. Accurately document results of inspection / testing and maintain controlled document files, logs and test records. Inspect cables per wiring configuration. Initiate non-conformance process and assist in resolving non-conformances. Monitor receiving inspection backlog. Able to be flexible with the work schedule. Process SAP transactions to segregate and disposition non-conforming product. Other duties and responsibilities in the Quality Department as assigned. Ability to conduct basic troubleshooting and problem resolution. Education and Experience: High School Diploma or Equivalent. Preferred one year of experience in an FDA regulated environment and/or ISO 13485 standards in the medical device industry and/or in-vitro diagnostics preferred. Technical and physical position requirements: Familiar with measuring equipment such as micrometer, caliper height gauges, plug gauges. Able to lift at least 35 lbs. Strong attention to details and ability to understand and follow complex procedures. Working knowledge and experience in basic computer applications such as Microsoft Word, Excel and Outlook. Effective and clear written and verbal communication skills in English language. The US base salary range for this full-time position is $20.60 - $31.60. Our salary ranges are determined by role, level, and location. The range displayed on each job posting reflects the base pay target range for new hire salaries for the position. Within the range, individual pay is determined by work location and additional factors, including job-related skills, experience, and relevant education or training. In addition to compensation, Zoetis offers a comprehensive benefits package that supports the physical, emotional and financial wellbeing of our colleagues and their families including healthcare and insurance benefits beginning on day one, a 401K plan with a match and profit-sharing contribution from Zoetis, and 4 weeks of vacation. Visit zoetisbenefits.com to learn more. Full time RegularColleague Any unsolicited resumes sent to Zoetis from a third party, such as an Agency recruiter, including unsolicited resumes sent to a Zoetis mailing address, fax machine or email address, directly to Zoetis employees, or to Zoetis resume database will be considered Zoetis property. Zoetis will NOT pay a fee for any placement resulting from the receipt of an unsolicited resume. Zoetis will consider any candidate for whom an Agency has submitted an unsolicited resume to have been referred by the Agency free of any charges or fees. This includes any Agency that is an approved/engaged vendor but does not have the appropriate approvals to be engaged on a search. Zoetis is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status or any other protected classification. Disabled individuals are given an equal opportunity to use our online application system. We offer reasonable accommodations as an alternative if requested by an individual with a disability. Please contact Zoetis Colleague Services at ********************************** to request an accommodation. Zoetis also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must possess or obtain authorization to work in the US for Zoetis. Zoetis retains sole and exclusive discretion to pursue sponsorship for the acquisition or maintenance of nonimmigrant status and employment eligibility, considering factors such as availability of qualified US workers. Individuals requiring sponsorship must disclose this fact. Please note that Zoetis seeks information related to job applications from candidates for jobs in the U.S. solely via the following: (1) our company website at ********************** site, or (2) via email to/from addresses using only the Zoetis domain of “@zoetis.com”. In addition, Zoetis does not use Google Hangout for any recruitment related activities. Any solicitation or request for information related to job applications with Zoetis via any other means and/or utilizing email addresses with any other domain should be disregarded. In addition, Zoetis will never ask candidates to make any type of personal financial investment related to gaining employment with Zoetis.
    $20.6-31.6 hourly Auto-Apply 60d+ ago
  • Manual Inspector Trainee (3pm-11:30pm)

    American Regent 4.7company rating

    Shirley, NY jobs

    Nature and Scope The Manual Inspector Trainee is an entry level position responsible for the manual inspection of our products using visual methods to detect particulates in vials, liquid volume, defects, etc. Trainees must pass a Visual Inspection Qualification Test and pass qualifications to operate automated inspection equipment before becoming an Inspection Machine Operator I. Essential Duties and Responsibilities Performs inspection of vial, ampoule, and syringe containers by hand (manually). Accurately completes all documentation associated with tasks performed. Keeps work area clean and orderly. Follow directives issued by leads and supervisors. Adheres to good manufacturing practices, (GMP & cGMP). Perform duties according to the company's standard operating procedures, (SOPs). Education Requirements and Qualifications High School Diploma or Equivalent required. Must pass a Visual Inspection Qualification test within 89-day probationary period. This is a temporary position, in which candidate must complete the qualifications to become an Inspection Machine Operator I within 89 days. Accurately read, write and count. Able to work effectively with others. Ability to work overtime as needed. Physical Environment and Requirements Specific vision requirements include 20/20 near vision (can be corrected with eyeglasses or contacts) and color vision. Able to stand and sit for extended periods. Able to lift 10 pounds repeatedly (5-6 hours). Able to lift 11-25 pounds occasionally (1-2 hours). Expected hourly rate: $19.27 The hourly rate displayed is the hourly rate for the role that the employer in good faith believes to be accurate at the time of the posting of an advertisement for the role. Actual compensation for the role will be based on a number of different factors including but not limited to the candidate's qualifications, education, knowledge, skills and experience. American Regent also offers a competitive total rewards package which includes healthcare, life insurance, profit sharing, paid time off, matching 401k as well as a wide range of other benefits. American Regent celebrates diversity and we are committed to creating an inclusive environment for all employees. 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, national origin, disability status, or protected veteran status. Applicants have rights under Federal Employment Laws. FMLA poster: ********************************************************** Know Your Rights: Know Your Rights: Workplace discrimination is illegal (eeoc.gov) Employee Polygraph Protection Act: ********************************************************* Alert: We're aware of individuals impersonating our staff to target job seekers. Please note: · All legitimate communication will come directly from a verified ARI recruiter either by phone or via an americanregent.com email address. · Our recruiting process includes multiple in person and/or video interviews and assessments. · If you are unsure about the legitimacy of a message, contact John Rossini at *************************** before responding. · We never request payment, bank information, or personal financial details during our offer process. Your security is important to us, and we encourage you to stay vigilant when job searching. American Regent Inc. endeavors to make *********************************** accessible to any and all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please email **************************************.
    $19.3 hourly Auto-Apply 9d ago
  • Manual Inspector Trainee (3pm-11:30pm)

    American Regent Laboratories 4.7company rating

    Shirley, NY jobs

    Nature and Scope The Manual Inspector Trainee is an entry level position responsible for the manual inspection of our products using visual methods to detect particulates in vials, liquid volume, defects, etc. Trainees must pass a Visual Inspection Qualification Test and pass qualifications to operate automated inspection equipment before becoming an Inspection Machine Operator I. Essential Duties and Responsibilities * Performs inspection of vial, ampoule, and syringe containers by hand (manually). * Accurately completes all documentation associated with tasks performed. * Keeps work area clean and orderly. * Follow directives issued by leads and supervisors. * Adheres to good manufacturing practices, (GMP & cGMP). * Perform duties according to the company's standard operating procedures, (SOPs). Education Requirements and Qualifications * High School Diploma or Equivalent required. * Must pass a Visual Inspection Qualification test within 89-day probationary period. This is a temporary position, in which candidate must complete the qualifications to become an Inspection Machine Operator I within 89 days. * Accurately read, write and count. * Able to work effectively with others. * Ability to work overtime as needed. Physical Environment and Requirements * Specific vision requirements include 20/20 near vision (can be corrected with eyeglasses or contacts) and color vision. * Able to stand and sit for extended periods. * Able to lift 10 pounds repeatedly (5-6 hours). * Able to lift 11-25 pounds occasionally (1-2 hours). Expected hourly rate: $19.27 The hourly rate displayed is the hourly rate for the role that the employer in good faith believes to be accurate at the time of the posting of an advertisement for the role. Actual compensation for the role will be based on a number of different factors including but not limited to the candidate's qualifications, education, knowledge, skills and experience. American Regent also offers a competitive total rewards package which includes healthcare, life insurance, profit sharing, paid time off, matching 401k as well as a wide range of other benefits. American Regent celebrates diversity and we are committed to creating an inclusive environment for all employees. 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, national origin, disability status, or protected veteran status. Applicants have rights under Federal Employment Laws. * FMLA poster: ********************************************************** * Know Your Rights: Know Your Rights: Workplace discrimination is illegal (eeoc.gov) * Employee Polygraph Protection Act: ********************************************************* Alert: We're aware of individuals impersonating our staff to target job seekers. Please note: * All legitimate communication will come directly from a verified ARI recruiter either by phone or via an americanregent.com email address. * Our recruiting process includes multiple in person and/or video interviews and assessments. * If you are unsure about the legitimacy of a message, contact John Rossini at *************************** before responding. * We never request payment, bank information, or personal financial details during our offer process. Your security is important to us, and we encourage you to stay vigilant when job searching. American Regent Inc. endeavors to make *********************************** accessible to any and all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please email **************************************.
    $19.3 hourly Auto-Apply 42d ago

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