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Quality Assurance Inspector jobs at Amneal Pharmaceuticals - 71 jobs

  • Quality Assurance Inspector - 2nd Shift

    Amneal Pharmaceuticals, Inc. 4.6company rating

    Quality assurance inspector job at Amneal Pharmaceuticals

    The QA Inspector monitors and ensures all incoming raw materials, packaging components and returned goods are sampled, inspected and tested (where applicable) for the purpose of determining compliance with established specifications. The QA Inspector must monitor and ensure all phases of drug manufacturing are in compliance with established specifications; receive, inspect, release and control of labels and outserts, to ensure quality compliance before, during and after each packaging run. Essential Functions: * Perform inspection, sampling, and testing of incoming raw materials, packaging components, and returned goods per written procedures. * Prepare samples for chemical and microbiological analysis and deliver them to the QC lab. * Inspect and test packaging components using measuring devices (e.g., scales, micrometers, height gauges) to ensure specification compliance. * Maintain detailed records of all sampling, inspection, and testing activities. * Assign and verify expiry and retest dates for GMP raw materials using vendor and in-house Certificates of Analysis (COA). * Collect packaged product samples for annual stability studies. * Conduct room, equipment, and packaging line checks before each manufacturing stage. * Perform in-process testing as per manufacturing and packaging batch record instructions. * Prepare finished product samples for QC lab and QA retains, following documentation protocols. * Maintain standard weights for daily balance verification. * Label component receipt: visual examination, counting, preliminary inspection, and sampling. * Prepare inspection reports for labeling components/outserts; manage quarantine and release labels, and maintain logs and inventory cards. * Issue labeling components/outserts per packaging orders; monitor and audit label room activities. * Complete QA final labeled product inspection reports and final line clearance, including reconciliation paperwork. * Ensure warehouse compliance: proper isolation of Quarantine, Released, In-Process, Finished, Packaged, Returned, and Rejected goods. * Isolate and document rejected materials during batch processes, ensuring accountability in batch records. * Monitor facility and product environmental operating conditions. Additional Responsibilities: * Operate, maintain and calibrate Hardness tester, Fibrillatory, Weight Variation system, weighing scales and balances, label counting machine, and Kirby Lester tablet counters according to established schedules and maintain detailed calibration records * Collection of samples to reassay bulk finished product before expiration * Work in a Contained Manufacturing area/facility following all precautions and procedures * Visual inspection and preparation of report of all products for APR * Other duties as assigned by management.
    $41k-54k yearly est. Auto-Apply 3d ago
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  • Quality Control Inspector II (3-Month Contract)

    Tandem Diabetes Care 4.6company rating

    Irvine, CA jobs

    GROW WITH US: Tandem Diabetes Care creates new possibilities for people living with diabetes, their loved ones, and their healthcare providers through a positively different experience. We'd love for you to team up with us to “innovate every day,” put “people first,” and take the “no-shortcuts” approach that has propelled us to become a leader in the diabetes technology industry. STAY AWESOME: Tandem Diabetes Care is proud to manufacture and sell the Tandem Mobi system and t:slim X2 insulin pump with Control-IQ+ technology - an advanced predictive algorithm that automates insulin delivery. But we're so much more than that. Our company's human-centered approach to design, development, and support delivers innovative products and services for people who use insulin. Because many of our own team members live with diabetes, or have a loved one impacted by diabetes, the work is personal, and we are committed to the cause. Learn more at tandemdiabetes.com A DAY IN THE LIFE: Performs inspections and testing on raw materials and sub-assemblies to identify non-conforming material and product and may assist in evaluation of non-conformances. Performs routine and non-routine testing of sub-assemblies and finished product with limited supervision according to material and product specifications, following Standard Operation Procedures (SOPs) and Work Instructions (WIs). Compiles data for evaluation of department Key Process Indicators (KPIs). Assists with validating inspection and testing processes. Quality Control Inspector II's at Tandem are also responsible for: Performs dimensional inspections on raw materials and incoming components. Performs testing on prototype and production product to support Product Development, Quality, and Manufacturing Technology engineers. Performs testing using an automated vertical tension and compression machine. Performs flow testing using various flow measurement and pressure systems. Develops and maintains lab apparatus and test methods. Maintains performance and calibration of lab equipment. Prepares sample product for testing and maintains proper documentation for product traceability. Assists in ordering lab supplies, standards, solvents and tracking inventory. Works with Product Development and Quality engineers to improve existing testing methodologies and SOPs to increase lab efficiency. Properly documents all work on appropriate forms as required by test protocols and SOPs. Utilizes and maintains a laboratory notebook. Complies with safety and operating policies and procedures regarding equipment, materials, and the finished product. Tests components, in-process, and finished product independently following established SOPs and WIs. Performs quality material and product measuring, testing and release using established SOPs and WIs. Interprets engineering specifications and drawings and performs inspections, product segregation and verification. Maintains department documentation, inventory of measurement equipment, and ensures calibration and preventive maintenance records for inspection equipment are current. Performs preventive maintenance on equipment, as required. Performs set-up/preparation of equipment, cleaning, changeover of lines and general housekeeping. Maintains a safe work environment; thoroughly reads and understands the material safety data sheets (SDS) for proper handling of materials, follow operating and maintenance instructions for tools and machinery, and utilizes relevant manuals for proper operating procedures. Performs verification and validation activities in accordance with company QMS, ISO, and FDA standards. Understands and applies GDP, GLP, and GMP. Ensures work is performed in compliance with company policies including Privacy/HIPAA and other regulatory, legal, and safety requirements. Performs other assignments or projects as directed. WHEN & WHERE YOU'LL WORK: Onsite: This position is fully onsite and open to candidates located in Irvine, California. Equipment for the role will be provided and training will occur onsite. Schedule: This position will work Monday - Friday from 8:00 AM - 5:00 PM PST. WHAT YOU'LL NEED: Knowledge, skills & abilities: Knowledgeable with QSRs. Must have strong cGMP documentation skills. Working knowledge of small scale electromechanical device assembly operation, Ability to effectively share information regarding issues in written or verbal form and making recommendations in a clear and concise manner. Skilled at promoting team cooperation and a commitment to team success. Demonstrated ability to effectively prioritize and handle multiple priorities and complete assignments on time and with minimal errors. Proficient with Microsoft Office and Internet. Minimum certifications/educational level: HS Diploma or equivalent required, with some post high school technical training preferred. Minimum experience: 4+ years relevant QC Inspection experience, preferably in an FDA regulated industry. Experience with QSRs and cGMP including basic knowledge of QC systems. Experience utilizing sampling methodologies and tools. Experience measuring materials with visual inspection systems. Experience with medical device consumer products a plus. COMPENSATION: The starting base pay range for this position is $27.00 - $30.00 per hour. Base pay will vary based on job-related knowledge, skills, experience and may also fluctuate depending on candidate's location and the overall job market. Please note that is a temporary position. As a temporary employee you will be employed through a staff agency partner. Benefits during your temporary assignment may be provided by the staffing agency. Access to Tandem sponsored benefits is contingent upon conversion from temporary to regular full-time status. Conversion is determined based upon business need and job performance. YOU SHOULD KNOW: Qualified applicants with arrest or conviction records will be considered for employment in accordance with applicable state and local Fair Chance laws and regulations. A conditional offer of employment from Tandem is contingent upon successful completion of a pre-employment screening process comprised of a drug test (excluding marijuana) and background check, which includes a review of criminal history information. Tandem has good cause to conduct a review of criminal history information of candidates for this position, as this role may involve access to proprietary, sensitive and/or confidential information, including customer protected health information. This review is required to ensure that individuals in such roles uphold high standards of trust and integrity so as to protect the interests of our customers, employees, and stakeholders. SPONSORSHIP: Applicants must be authorized to work for any employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time WHY YOU'LL LOVE WORKING HERE: At Tandem, we believe joy fuels excellence. That's why we've built a workplace that celebrates your achievements and supports your well-being. Our team thrives on pushing boundaries and fostering growth, all while maintaining a spirit of fun and camaraderie. This is just one of the ways we stay awesome! Explore the benefits and reasons to love Tandem at *************************************** BE YOU, WITH US! We embrace the value that every single one of us brings to the table. But sometimes we forget that when we don't meet 100% of a job description's criteria - maybe you're feeling that way right now? We encourage you to apply anyway. Because we want you to be you, with us. Tandem is firmly committed to being an equal opportunity employer and does not discriminate on the basis of age, disability, sex, race, religion or belief, gender identity or expression, marriage/civil partnership, pregnancy/maternity, or sexual orientation. We are an inclusive organization, and we welcome applications from a wide range of candidates. Selection for roles will be based on individual merit alone. REFERRALS: We love a good referral! If you know someone who would be a great fit for this position, please share! APPLICATION DEADLINE: The position will be posted until a final candidate is selected for the requisition or the requisition has a sufficient number of applications. Make a move that matters. Join Tandem Diabetes Care, where we're turning challenges into triumphs every day and where your talents will help shape a healthier, happier tomorrow. #LI-HJ1
    $27-30 hourly Auto-Apply 25d ago
  • QA Inspector, QA - 2nd Shift

    Hikma Pharmaceuticals 4.9company rating

    Cherry Hill, NJ jobs

    We continue to be 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 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. Preferred Qualifications: * Prior QA experience preferred Compensation: Hourly Rate: $24.00 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. 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
    $24 hourly Auto-Apply 27d ago
  • QA Inspector, QA - 3rd Shift

    Hikma Pharmaceuticals 4.9company rating

    Cherry Hill, NJ jobs

    Job Title: QA Inspector (3rd Shift, Tuesday-Saturday) 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: $24.00 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. Location: Cherry Hill, NJ, US, 08003 Nearest Major Market: Philadelphia
    $24 hourly Auto-Apply 28d ago
  • QA Inspector, QA - 2nd Shift

    Hikma Pharmaceuticals USA Inc. 4.9company rating

    Cherry Hill, NJ jobs

    We continue to be 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 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. Preferred Qualifications: Prior QA experience preferred Compensation: Hourly Rate: $24.00 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. 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.
    $24 hourly 13d ago
  • Quality Assurance Inspector II - 3rd Shift

    Amneal Pharmaceuticals 4.6company rating

    Quality assurance inspector job at Amneal Pharmaceuticals

    This role is responsible for monitoring and ensuring that all incoming raw materials, packaging components, and returned goods are properly sampled, inspected, and tested, as applicable, to confirm compliance with established specifications. To monitor and ensure all phases of drug manufacturing are in compliance with established specifications. To receive, inspect, release and control of labels and outserts. To ensure quality compliance before, during and after each packaging run. Essential Functions: Perform inspection, sampling, and testing (where applicable) on all incoming raw materials, packaging components, and returned goods following detailed written procedures. Prepare samples for chemical and microbiological analysis (where required) and deliver them to the QC lab. Inspect and test packaging components using various measuring devices such as scales, micrometers, and height gauges to determine conformance to specifications. Maintain detailed records of sampling, inspections, and testing activities. Assign and verify expiry dates and retest dates for all GMP raw materials through vendor COA and in-house COA. Collect packaged product samples for annual stability. Perform room, equipment, and packaging line checks (where applicable) prior to each stage of manufacturing following detailed written procedures. Conduct in-process testing per manufacturing and packaging batch record instructions. Prepare controlled/uncontrolled/packaged finished product samples for QC lab and QA retains, following detailed documentation procedures. Maintain standard weights required to perform daily verification of balances. Handle labeling component receipt, visual examination, counting, preliminary inspection, and sampling. Prepare labeling components/outserts inspection reports; quarantine and release labels; maintain incoming components log and corresponding inventory cards. Issue labeling components/outserts according to packaging order and regularly monitor and audit the label room. Complete QA final labeled product inspection report and final line clearance, including labeling and packaging reconciliation paperwork. Ensure compliance of warehouse areas in terms of isolation of Quarantine, Released, In-Process, Finished Product, Packaged Product, Returned Goods, and Rejected areas. Ensure proper isolation of rejected material generated during batch process and accountability in the batch record. Monitor facility and product environmental operating conditions. Review engineering records (temperature and humidity data, calibration and PM records, pest control records, and contractor-related functions). Review online batch records for completeness of signatures, entries, and reconciliation/yields prior to initiation of the next processing step. Verify functionality of all equipment and associated controls during the batch run. Maintain retention sample room and monitor temperature and humidity; replace chart records as per schedule; review logs and disposition of samples. Additional Responsibilities: Disposition of rejected material and returned drug products as per SOP Performs environmental monitoring in accordance with established schedule (where applicable) Perform applicable testing and prepare report for customer complaints Other duties that management may assign. Education: High School or GED - Required Experience: Must have 2 years or more experience in QA or related field Skills: High energy level and organizational skills. - Advanced A certain degree of creativity and latitude - Advanced Basic computer skills (Word and Excel) - Intermediate Specialized Knowledge: Good basic math knowledge and excellent attention to details. Records observations for improving processes.
    $41k-54k yearly est. Auto-Apply 13d 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. 13d ago
  • QA Inspector (3pm-11:30pm)

    American Regent 4.7company rating

    Shirley, NY jobs

    Nature and Scope This position is responsible for providing Quality oversight in manufacturing areas including, but not limited to Formulation, Filling, Inspection, Equipment Prep and Packaging through the execution of site policies and procedures, programs, and work instructions. This position ensures all processes and products meet specifications and that products are produced in accordance with cGMP requirements. The QA Inspector maintains compliance with quality programs. Essential Duties and Responsibilities All inspections are conducted in compliance with the Code of Federal Regulations (CFR 211.134) Drug product inspection. Achieve and maintain Aseptic Processing Area (APA) gown qualification. Adhere to all SOP related to working in an aseptic environment, including volume/weight checks of product filled in vials and ampoules; s well as the monitoring of personnel Aseptic Technique. Checks product lot number information, documents in the batch record where applicable, and reviews Master Batch Records for accuracy at all stages in the manufacturing process - Formulation, Filling, Inspection, and Packaging. Conducts product in-process inspections at designated intervals. Determines the Acceptable Quality Limits (AQL) by using the (American Nation Standards Institute) ANSI Z1.4 Standard Inspectors Rule, the ruler assists with the calculation of sample size and Accept/Reject (A/R) numbers. Conducts inspection of formulation equipment (e.g. tanks) for cleanliness, imperfections, and acceptable operating condition. Documents verification of task performed (where applicable). Conducts visual inspection of filled vials and ampoules after manual or automated inspection for defined critical major and minor defects, as well as particulate matter. Conducts inspection of printed materials (e.g. labels), inserts, finished units, unit packs, and shipping containers for critical major and minor defects. Perform monthly inspection of the retentions samples to ensure quality of finished products until expiration. Assist in the management of the sample retention room (removing samples for monthly inspections, putting away samples from monthly inspections, adding new samples to the room, and removing samples from the room that have expired). Reports all non-conformances to supervision. Education Requirements and Qualifications High School Diploma or GED equivalent, required. 1 year of related experience in Quality Assurance and/or manufacturing within a cGMP environment, preferred. Experience in a pharmaceutical, biotech, food, or related manufacturing environment, preferred. Working knowledge of good manufacturing systems, familiarity with regulatory and manufacturing SOPs and cGMPs, preferred. Ability to perform accurate mathematical calculations, required. Basic computer skills including Microsoft Outlook, Word, Excel, required. Strong attention to detail, adherence to SOPs, and a desire for ensuring a high-quality product. Must be able to read documents in Standard English such as Standard Operating Procedures, maintenance schedules and operating manuals. Ability to meet and maintain sterile gowning requirements. Ability to work overtime as needed, including weekends when required. Physical Environment and Requirements Employee must be able to occasionally lift and/or move up to 25 pounds. 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. Expected Hourly Rate: $23.61-$25.00 The hourly rate displayed is the minimum and maximum hourly rate of compensation 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 **************************************.
    $23.6-25 hourly Auto-Apply 5d 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
  • 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 54d 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: Dec 19, 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, Medical Device, Facilities, Quality, Healthcare, Operations
    $21.9-30.8 hourly 60d+ ago
  • Quality Assurance Coordinator

    Revance 4.2company rating

    Johnson City, TN jobs

    The QA Coordinator - Investigations & CAPA supports site Quality Systems by executing and managing deviations, and CAPAs, compliance with FDA 21 CFR 210/211/11 and ICH Q10. This role drives timely, thorough investigations, applies root cause analysis, ensures effective CAPA implementation, Effectiveness and maintains inspection-ready documentation to uphold product quality and data integrity Reporting to: QA Supervisor Location: Plant Hours: Monday - Friday: 8:00am - 4:00pm Responsibilities/Essential Duties: Investigations and CAPA Management Leads or supports investigations for deviations, OOS/OOT events, nonconformances, and complaints to ensure timely, complete, and compliant documentation per 21 CFR 211.192 and ICH Q9/Q10. Performs structured Root Cause Analysis (5-Why, Fishbone, FMEA) to identify true root causes and prevent recurrence. Develops and manages Corrective and Preventive Actions (CAPAs) that are specific, measurable, and linked to verified root causes, ensuring implementation, verification, and documented effectiveness within defined timelines. Analyzes and trends investigation and CAPA data to identify systemic issues, recommends process or procedural improvements, and reports performance metrics to Quality leadership. Ensures all records meet ALCOA+ data-integrity standards and are inspection-ready. Promotes a culture of investigative rigor, continuous improvement, and accountability across Manufacturing, QC, and Engineering functions. Qualifications: Education & Experience Bachelor's degree in Life Sciences, Engineering, or related technical field required. Minimum 1-4 years of Quality Assurance experience in a cGMP-regulated pharmaceutical, OTC, or medical device environment. Demonstrated expertise in managing deviations and CAPAs, Experience with FDA inspections and supporting regulatory audits is highly preferred. Technical Skills In-depth knowledge of 21 CFR Parts 210, 211, 11, ICH Q7-Q10, and relevant USP chapters. Proficiency in root cause analysis tools and Six Sigma methodologies. Experience using electronic Quality Management Systems (eQMS) such as MasterControl, Veeva, or ETQ Reliance. Familiarity with data integrity requirements and ALCOA+ compliance. Key Competencies Investigative Rigor: Executes high-quality, inspection-ready investigations with accurate root cause identification. CAPA Execution: Ensures timely, effective, and risk-based corrective actions. Compliance Stewardship: Upholds data integrity and documentation standards across all QA systems. Collaboration: Works effectively across departments to align investigation outcomes with operational needs. Accountability: Tracks and deliveries on commitments with minimal supervision. Working Conditions: Primarily office-based with routine interaction in manufacturing and laboratory environments. May require off-shift or weekend support during audits, investigations, or operational escalations. Occasional travel may be required for training or supplier quality support Company Summary: Crown is a proud member of the Revance Portfolio of skincare offerings. Revance is a fast-growing global aesthetics and skincare company focused on providing innovative aesthetics and market-leading skincare offerings throughout every stage of life. With a differentiated portfolio of products spanning 60 countries, Revance meets the evolving needs of patients and consumers worldwide through continued innovation and commercialization of new products and treatments. What Revance invests in you: Competitive Compensation including base salary and annual performance bonus Paid time off, holidays, and floating holidays that can be used for whatever you choose Generous healthcare benefits, Employer HSA match, 401k match, wellness discounts and much more This section of the is required by the American with Disability Act (ADA). The ADA requires that job descriptions reflect the physical and mental demands required to effectively perform the essential duties of the job. The ADA prohibits employers from discriminating against a “qualified individual with a disability” in all aspects of the employment relationship. A “qualified individual with a disability” is “an individual who meets the education, experience, skill, and other job-related requirements of a position held or desired, and who, with reasonable accommodation, can perform the essential functions of a specified job.” Revance is an Equal Opportunity employer. All qualified applicants will receive consideration for employment based on merit, without regard to race, color, religion, sex, national origin, disability, protected Veteran Status, or any other characteristic protected by applicable federal, state, or local law.
    $59k-82k yearly est. Auto-Apply 55d 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
  • QC Inspector II

    Arthrex 4.8company rating

    California 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.
    $21.9-30.8 hourly 60d+ ago
  • Skilled - Quality Control Inspector

    QPS Employment Group 4.5company rating

    Elk Grove Village, IL jobs

    Quality Control Inspector Wage: $25.00 - $26.00/hour Shift: 1st Hours: 7:00am - 3:30pm Are your skills not being fully utilized? Reach your maximum potential by working with QPS! QPS Employment Group has a great opportunity available for a Quality Control Inspector at a company in Elk Grove Village, IL. This is a direct hire position for 1st shift. Apply now! Quality Control Inspector Responsibilities: - Perform incoming, in-process and final inspections against accept / reject criteria on customer parts while working with critical tolerances - Utilize mathematical skills and methods of tolerance analysis to determine potential removal/buildup of substrate regarding dimensional change - Understand, assess and perform test methods using instruments such as micrometers, eddy current thickness testers, bore gages, gloss meters, etc. - Perform contract / flow down review as needed, ensuring adherence to externally supplied documents including purchase orders, engineering drawings, specifications and customer work instructions - Complete pertinent data records including job log entry, job routing package, inspection logs, job techniques and customer specific requirements - Operate precision measuring equipment such as micrometers, calipers, bore and thread gages, fixtures, microscopes etc. - Review, complete and/or ensure adherence to MIL's internal documentation including work orders, processing techniques, inspection reports, frozen plans and MIL's general procedures - Provide cross-functional support to QCI and QA personnel and contribute toward peripheral projects and tasks as needed - Recommend improvements to production to ensure quality control - Perform additional duties as assigned or required to support organizational goals and objectives - Participate in applicable ongoing training sessions, continuous process improvement programs, periodic testing, and performance evaluations Requirements for Quality Control Inspector: - High School Diploma or equivalent; College degree preferred - At least four years of dimensional inspection experience in aerospace/defense, avionics, medical or similar industry - Experience evaluating and interpreting engineering drawings - PC proficient with a comprehensive understanding of Microsoft Office applications - Understanding of QA sampling plans including visual and dimensional examinations and other ancillary test methods strongly preferred - Bilingual in English/Spanish a plus - Advanced GD&T skills - Ability to take tight tolerance measurements (+/- .00005 - .0002) while maintaining accuracy and throughput - Ability to perform calibration/verification on measurement tools - Detail-oriented, organized, self-starting individual with excellent written and verbal communication and interpersonal skills - Prioritize and complete tasks with consistency and accuracy, often under pressure and/or short deadlines - Knowledge of plating, anodize, etching, or Nadcap principles is desirable ...@qpsemployment.com IND999 QPS Employment Group is a full-service staffing firm comprised of dedicated and passionate people with over 50 offices throughout the United States. We place great people with great companies in industrial, skilled trades, administrative, manufacturing, general labor and professional employment. Hiring immediately! Why Work with QPS? - Access to sought-after positions with leading employers - Dedicated placement specialists who will guide you through every step of the job search process
    $25-26 hourly 1d 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
  • Quality Technician 503B

    Eagle Pharma Outsourcing LLC 4.5company rating

    Birmingham, AL jobs

    Job Description The Quality Technician ensures that all compounded products are manufactured in accordance with current Good Manufacturing Practices (GMP) and also meet all internal specifications. This position is responsible for performing a number of manual and automated quality assurance checks on in-process products and finished goods. This position requires strong organizational skills and the ability to prioritize work and respond to customer demands in a timely fashion are critical requirements of this position. This position is responsible for working collaboratively with other personnel in the Quality Department to ensure the highest quality product is delivered to the consumer. Job Activities and Responsibilities: Collect and send samples of compounded sterile preparations (CSPs) for sterility, potency, and endotoxin testing. Conduct environmental monitoring (e.g., air and surface sampling) in cleanrooms to ensure compliance with regulatory standards. Perform visual inspection of finished drug products. Maintain incubation schedules of environmental monitoring sample plates and document results in associated reports and batch records. Maintain accurate and thorough records of all testing and inspections. Ensure all documentation complies with FDA 503B regulations, USP standards, and internal SOPs. Review batch records and verify that all procedures were followed correctly. Assist in internal and external audits to ensure compliance with FDA regulations, USP , USP, and other applicable guidelines. Work closely with the Quality Assurance (QA) team to implement corrective and preventive actions (CAPAs) when non-conformities are identified. Maintain effective communication and partnership with Operations Management department. Participate in root cause analysis to find the sources of defects or quality problems. Ensure that all QC laboratory equipment is properly calibrated and maintained according to the manufacturer's specifications. Review of draft and executed batch records, release of pharmaceutical products, and QA review and approval of product label proofs. Participate in continuous improvement initiatives to enhance the quality control processes and overall product quality. Provide input on QC methods and assist in the development of new testing procedures as needed. Assist with SOP training, personnel training and competency assessments for handwashing/garbing and training of quality technicians. Train other staff members on QC procedures and best practices. Stay current with new regulations, guidelines, and techniques related to quality control in 503B compounding Oversight of validation projects (i.e. equipment, facility, methods, and process), deviation investigations, and CAPA and Out of Specifications (OOS) investigations. Ensure all QC activities comply with FDA 503B requirements and other relevant regulatory bodies. Prepare and review QC sections of regulatory submissions. Under the direction of supervisor/lead, document, initiate, and investigate quality events for deviations and noncompliance. Conduct internal audits and gap analysis of processes, systems, and procedures. Assist with external, regulatory inspections. Maintain quality records (equipment calibration and maintenance, training, deviation and noncompliance investigations, environmental monitoring, Certificate of Analysis, clean room certification etc.). Maintain quality standards by approving incoming materials, in-process production, and finished products. Receive, store, and log in samples for testing analysis. Participate in investigations into any deviations, out-of-specification results, or product complaints. Collaborate with QA to resolve issues and prevent recurrence. Other duties, responsibilities and qualifications may be required and/or assigned as necessary. Qualifications and Education Requirements Compounding, cGMP, and/or laboratory experience preferred High school diploma required and Associates or Bachelor's degree in Health Sciences/Microbiology preferred Must be able to follow gowning/garbing procedures including wearing all protective gear (gown, hair bonnet, mask, beard cover, gloves, goggles) as outlined in site SOPs Strong written communication and interpersonal skills. Demonstrated ability to work in a demanding, high performance work environment and create a positive, team-oriented culture. Must be well organized and detail-oriented with proven initiative and self-starter skills. Must possess problem solving and analytical skills Demonstrated ability to direct individuals and delegate responsibilities and tasks Excellent work ethic, including a personal drive to excel independently. Solid PC skills including Microsoft Office Suite (Word, Excel, Outlook) 20/20 Vision (either aided or unaided) as required by CGMP regulations for visual inspection of finished drug products. Physical requirements: Ability to use a computer and computer-related equipment, printer/fax machine Prolonged periods of sitting and/or standing. Communicate by telephone and email Lift to forty (40) pounds at times. 20/20 vision (either aided or unaided) Benefits: Health care insurance (medical, dental, vision) Life Insurance Supplemental Insurance PTO 401K matching Sick leave
    $28k-37k yearly est. 30d ago
  • Quality Technician - Visual Inspection

    Eagle Pharma Outsourcing LLC 4.5company rating

    Birmingham, AL jobs

    Job Description A Quality - Visual Inspection Technician is a key member of the Quality Team and plays a critical role in ensuring that compounded pharmaceutical products are accurately prepared and without defects. Visual inspection is the first of several post-production activities where filled compounded products are visually evaluated for product defects. This technician is responsible for working with production and quality staff to prioritize batches for visual inspection, completing visual inspection of batches within reasonable timeframes, appropriately classifying observed defects, and performing additional pre-release inspections. While visual inspection is the main emphasis for this position, this position will also participate in other quality related tasks and duties. Job Activities and Responsibilities: The responsibilities listed below are subject to change. Post-Production Visual Inspection of Finished Drug Products Perform visual inspection of unlabeled finished drug products Classify observed defects into pre-defined categories Calculates percent defects on inspection results and reconciles components Proper documentation of visual inspection activities on associated compounding records in accordance with procedures, CGMP, and CGDP Labeling of Finished Drug Products Label all products following facility and regulatory requirements Perform post-labeling inspections Quality Control Functions and Tasks Perform environmental and personnel monitoring associated with batch production Conduct routine environmental monitoring of controlled compounding areas Record room conditions in appropriate monitoring software Other routine quality control tasks as determined by the Quality Management Quality Assurance and Compliance Adhere to FDA 503B guidelines, cGMP standards, and USP requirements to ensure product safety and quality. Follow established protocols for documentation, reporting, and record-keeping Safety and Facility Maintenance Follow safety protocols, including proper gowning, hand hygiene, and equipment sanitation Participate in routine facility cleaning schedules, ensuring a clean work environment Report any equipment malfunctions or safety concerns to supervisors Assist other process functions as required. Qualifications and Education Requirements Educational Background: High school diploma or equivalent; licensed as a pharmacy technician with the Alabama State Board of Pharmacy. Experience: Prior experience in a pharmacy, healthcare, or manufacturing environment, especially in sterile compounding or quality. Attention to Detail: Effective organization skills, attention to detail, and the maintenance of precise records. Physical Requirements: Ability to stand for extended periods, lift moderate weights, and work in a controlled environment; must have 20/20 vision either aided or unaided and complete inspection certification Must have the ability to complete a two-day off-site training program Physical Requirements: Proficient in using a computer and related equipment, including printers and fax machines. Ability to sit or stand for extended periods. Effective communication skills via telephone and email. Able to work in a controlled environment Capable of lifting up to 40 pounds as needed. 20/20 vision (with or without corrective aids) required for visual inspection of drug products, in accordance with legal requirements. KEY COMPETENCIES Regulatory Knowledge: Familiarity with FDA, cGMP, and USP guidelines is a strong asset. Visual ability to detect defects (as demonstrated through competency assessments) Collaboration: Works well with cross-functional teams, including quality control, shipping, and pharmacists. Regulatory Compliance: Strong understanding of 503B regulations and dedication to following all facility protocols. Benefits: Health care insurance (medical, dental, vision) Life Insurance Supplemental Insurance PTO 401K matching Sick leave
    $28k-37k yearly est. 24d 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 40d 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 60d+ ago

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