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Quality Assurance Technician jobs at QuVa Pharma

- 94 jobs
  • Quality Assurance Technician 3rd Shift

    Quva 4.5company rating

    Quality assurance technician job at QuVa Pharma

    Our Quality Assurance Technician plays a vital role in ensuring the highest quality and safety standards of our pharmaceutical products. Once you complete our training, your responsibilities will include performs basic QA functions related to verification of incoming materials, label checks, and oversight of support areas (i.e. prep and/or label printing) to ensure the manufacturing areas are set up for success. The on-the-floor quality team is responsible for making sure the process and documentation records are compliant with patient safety in mind, executing with efficiency always. Quality, safety, and on-time delivery is a must to be successful in this role! This is a full-time role for our 3rd shift, working Monday through Friday from 10:00 PM to 6:30 AM. This is a set, consistent schedule with minimum overtime requirements and based on site in our Sugar Land, TX location. This is a safety sensitive position that may be subject to random drug testing, in accordance with applicable laws. Watch this video to learn more. What the Quality Assurance Technician Does Each Day: Ensure that all applicable US Regulatory requirements are being met within the procedures and practices Quality review / verification of critical information related to the receipt of incoming goods or the distribution of finished goods for customer orders Ensures compliance of incoming materials prior to use in Manufacturing Operations Ensures verification of labels against batch record requirements complies with company standards Ensures levels of cleanliness for components and equipment used in the manufacturing process meet the company standards Our Most Successful Quality Assurance Technicians: Are detail-oriented with strong verbal and written communications skills Express energy, show accountability, and multi-task Fulfill expectations, establish sustainable relationships with team members, maintain effective and meaningful communication channels Have good interpersonal skills and the ability to work effectively and efficiently in a team environment to accomplish goals Minimum Requirements for this Role: A High School diploma or equivalent Able to successfully complete a drug and background check Able and willing to walk, stoop, stand, bend, and lift up to 50 lbs. throughout each shift, with or without reasonable accommodation 18+ years of age 20/20 vision (with or without corrective lenses) and the ability to successfully pass a color vision test Familiarity with and comfortable using mobile devices such as smartphones, tablets, handhelds Must be currently authorized to work in the United States on a full-time basis; QuVa will not sponsor applicants for work visas Any of the Following Will Give You an Edge: 0 to 2 years' experience with FDA-regulated operations (cGMP processes) or Quality Assurance Benefits of Working at Quva: Set, full-time, consistent work schedule Comprehensive health and wellness benefits including medical, dental and vision 401k retirement program with company match 17 paid days off plus 8 paid holidays per year Occasional weekend and overtime opportunities with advance notice National, industry-leading high growth company with future career advancement opportunities About Quva: Quva is a national, industry-leading provider of compounded injectable medicines and software solutions that help power the business of hospital and health-system pharmacy. Quva Pharma produces and distributes injectable medicines required by health care providers and critical to patient care. Quva BrightStream partners with health-systems to analyze large amounts of data and through AI and machine learning, develops software solutions that turns the data into insights that are used to better run their pharmacy operation. Quva's overall product and technology offerings help health-systems achieve greater value and deliver the highest-quality patient care. Quva is an equal opportunity employer and is committed to creating and maintaining a work environment that is free from all forms of discrimination and harassment. Quva's Equal Opportunity Policy prohibits harassment or discrimination due to age, ancestry, color, disability, gender, gender expression, gender identity, genetic information, marital status, medical condition, military or veteran status, national origin, race, religious creed, sex (including pregnancy, childbirth, breastfeeding, and any related medical conditions), sexual orientation, and any other characteristic or classification protected by applicable laws. All employment with Quva is “at will.”
    $33k-44k yearly est. 60d+ ago
  • QC Laboratory Technician

    Quva 4.5company rating

    Quality assurance technician job at QuVa Pharma

    Our QC Laboratory Technician plays a vital role in ensuring the highest quality and safety standards of our pharmaceutical products. Once you complete our training, your responsibilities will include performing basic laboratory support functions related to the management of laboratory samples, materials, and testing supplies. Your attention to detail and adherence to precise procedures will guarantee that our medications meet the highest standards of safety, efficacy, and quality, providing patients with the best possible care and outcomes. Turn your passion for precision and your commitment to quality into a meaningful impact on healthcare across the US. This is a full-time role working Monday through Friday from 8:00 AM to 4:30 PM. This is a set, consistent schedule with minimum overtime requirements and based on site in our Bloomsbury, NJ location. This is a safety sensitive position that may be subject to random drug testing, in accordance with applicable laws. What the QC Laboratory Technician Does Each Day: Verifies information on incoming lab samples and enters sample information into the laboratory database Place orders and stock laboratory supplies Light housekeeping, including operation of glassware washer Ensures all work is performed and documented in a timely manner and according to approved standard operating procedures and in general compliance with cGMPs Our Most Successful QC Laboratory Technicians: Are accurate and well organized, with strong attention to detail Express energy, show accountability, can multi-task and work in a fast-paced, quality-rich environment Fulfill expectations, establish sustainable relationships with team members, maintain effective and meaningful communication channels Have good interpersonal skills and work effectively and efficiently in a team environment to accomplish goals Have strong verbal and written communications skills Minimum Requirements for this Role: A High School diploma or equivalent Able to successfully complete a drug and background check Proficient in Microsoft Office, Word and Excel Able and willing to walk, stoop, stand, bend, and lift up to 50 lbs. throughout each shift, with or without reasonable accommodation Must be currently authorized to work in the United States on a full-time basis; Quva will not sponsor applicants for work visas Any of the Following Will Give You an Edge: Bachelor's Degree in life science or related field 1 to 2 years' experience in data entry/clerical, or related responsibilities Benefits of Working at Quva: Set, full-time, consistent work schedule Comprehensive health and wellness benefits including medical, dental and vision 401k retirement program with company match 17 paid days off plus 8 paid holidays per year Occasional weekend and overtime opportunities with advance notice National, industry-leading high growth company with future career advancement opportunities Salary Range: $18.85-27.34/hour About Quva: Quva is a national, industry-leading provider of compounded injectable medicines and software solutions that help power the business of hospital and health-system pharmacy. Quva Pharma produces and distributes injectable medicines required by health care providers and critical to patient care. Quva BrightStream partners with health-systems to analyze large amounts of data and through AI and machine learning, develops software solutions that turns the data into insights that are used to better run their pharmacy operation. Quva's overall product and technology offerings help health-systems achieve greater value and deliver the highest-quality patient care. Quva is an equal opportunity employer and is committed to creating and maintaining a work environment that is free from all forms of discrimination and harassment. Quva's Equal Opportunity Policy prohibits harassment or discrimination due to age, ancestry, color, disability, gender, gender expression, gender identity, genetic information, marital status, medical condition, military or veteran status, national origin, race, religious creed, sex (including pregnancy, childbirth, breastfeeding, and any related medical conditions), sexual orientation, and any other characteristic or classification protected by applicable laws. All employment with Quva is “at will.”
    $18.9-27.3 hourly 11d ago
  • Quality Assurance Coordinator

    Isagenix 4.8company rating

    Gilbert, AZ jobs

    This position is responsible for executing and performing multiple cross-functional activities within Isagenix Quality Assurance program which includes functions in document control, quality control, quality assurance incoming product inspections and approvals, as well as product complaints. The position would provide management with briefings and timely reports reflecting the status of documents within a new document control system relevant to current documentation, actively participate in incoming quality assurance inspections, approvals, and rejections, as well as assisting with complaint monitoring and reporting. Work Schedule: This position currently follows a hybrid work model. Employees are required to work from the office at least four days per week (Monday - Thursday), with Friday available for remote work, offering a blend of in-person collaboration and flexibility. Essential Duties & Responsibilities (Other duties may be assigned) Actively work within the Isagenix Quality Management System (QMS), QualityOne, to support the quality functions in an efficient manner. Create, review, and revise Isagenix required documentation to ensure compliance to market regulations: FDA 21 CFR 111, 117, and others as applicable. Escalate any new, unknown product risks or hazards for further evaluation and decisions. Assist in coordinating and processing finished product master documents for external communication. Assist with creating, revising, and reviewing SOPs, Process Flow Charts, and other controlled documents. Track projects, provide updates and provide status reports, as required by management or QA procedures. Assist with organoleptic evaluations for product qualifications, release samples, shelf-life study samples and taste testing, as needed. Assist with collecting, reviewing, and organizing information for finished product specifications including analysis of testing methodologies. Assist with processing laboratory results, data collections, statistical evaluations, trend and prepare quality control reports based on results and data. Process, coordinate and track internal sample processing and sample submissions to contract laboratories. Maintain logs (laboratory, tracking, inventory, etc.) and analytical data in an organized, secure manner. Expand scope of Quality Control by identifying opportunities for improvement and solutions. May represent QA at company commercialization (POD) meetings, providing status updates on new products and relay all pertinent information to QA team, as needed. Support other areas or individuals within the Quality department as needed. Minimum Qualifications (These are the requirements that all applicants MUST HAVE to be considered for this position) Associate's degree in a fundamental science from an accredited institution or equivalent related experience. 1 year of analytical food laboratory experience. Knowledge of dietary supplement and food testing methods. No dietary restrictions or allergies. Location : Company Overview Established in 2002, Isagenix International has created simple, proven products that optimize what your body is capable of-helping you protect your greatest asset, your health. For more than twenty years, Isagenix has made holistic science an art with transparency and integrity-creating products and systems that address nutrition, stress, fitness, energy, natural beauty, focus, and financial wellbeing. The global wellbeing company, based in Gilbert, Arizona, markets its products through a network of independent distributors in 22 key markets: the United States, Canada, Puerto Rico, Australia, New Zealand, Mexico, the United Kingdom, Ireland, the Netherlands, Belgium, Spain, Austria, Denmark, Finland, France, Germany, Italy, Norway, Poland, Portugal, Sweden, and Switzerland. For more information, visit Isagenix.com. Location : EEO Isagenix International, LLC is an equal opportunity employer and affords equal opportunity to all applicants for all positions without regard to race, color, religion, sex, national origin, age, disability, veteran status or any other status protected by law.
    $44k-68k yearly est. Auto-Apply 60d+ ago
  • Quality Assurance Specialist

    Eurofins USA Biopharma Services 4.4company rating

    North Brunswick, NJ jobs

    Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins laboratories work with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate. The Eurofins network of companies is the global leader in food, environment, pharmaceutical and cosmetic product testing and in agroscience Contract Research Organization services. It is one of the market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, advanced material sciences and in the support of clinical studies, as well as having an emerging global presence in Contract Development and Manufacturing Organizations. It also has a rapidly developing presence in highly specialized and molecular clinical diagnostic testing and in-vitro diagnostic products. In over 30 years, Eurofins has grown from one laboratory in Nantes, France to 58,000 staff across a decentralized and entrepreneurial network of 900 laboratories in over 54 countries. Eurofins companies offer a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products. Job Description Job Summary: Under minimal supervision, the Quality Assurance Specialist III will ensure systems and processes are in a state of compliance with regard to internal, regulatory, and industry standards. He/she will promote a culture of quality for the Company. Candidates in this position will routinely report on the performance of the Quality System to senior leadership. Additionally, candidates will identify CAPAs, Deviations, Investigations, Change Controls, Process Improvements, and Root Cause Analysis. Candidates will participate in both internal (annual, in-process, for cause, etc.) and external (client, regulatory agencies, accreditation bodies, etc.) audits. Essential Duties/Responsibilities: Participate in all aspects of Quality Assurance to ensure regulatory activities are performed in compliance with both internal procedures and external cGXP/ISO requirements. Maintain the internal auditing program to ensure the established techniques are followed and understood. Participate in the planning, preparation, and hosting of customer and regulatory audits; respond to audit reports and implement resolution of audit findings. Maintain the Management Review process. Maintain the laboratory proficiency testing program. Collect, track, and analyze quality metrics (OOS, deviations, complaints, etc.) and train laboratory personnel, as needed to help reduce quality events. Monitor laboratory compliance with respect to lab cleanliness, training records, and other ISO/GMP-related items, as needed to help minimize laboratory errors and audit findings. Support quality event investigations to completion using formal root cause analysis tools. Support periodic summaries of audit outcomes and risk statements that identify whether there are uncontrolled risks within the QMS. Maintain the list of approved suppliers and subcontractors. Audits various reports prior to issuance (e.g. analysis reports, method validation reports, research and development reports (as needed), special project reports, etc.). Serve as site contact for all quality inquiries on analytical reports and related documentation. Audit methods, work instructions, deviations, investigations, corrective actions, preventative actions, risk assessments, and instrument qualification/calibration paperwork. Maintain site-specific procedures including the Quality Manual, Standard Operating Procedures, and other site-specific Quality Assurance documents. Create, revise, review, and approve newly written documents and document revisions. Work with Operations Management to maintain the training program and ensure that laboratory personnel performing tests have completed all necessary training requirements. Trains laboratory personnel in GXP/ISO procedures, practices, and guidelines. Exist as a backup for all other Quality Assurance personnel. Qualifications Education: A bachelor's degree or higher in a scientific field (chemistry, biology, or life science). Experience: 3-5 years of experience in Quality Assurance within a laboratory or regulated industry (e.g., pharmaceuticals, biotechnology, medical devices). Must have experience working in a GMP facility. ISO 17025:2017 accredited lab experience preferred. Moderate understanding of microbiology and/or chemistry-related terms and testing. Moderate understanding of USP/EP/JP standards and guidelines. Moderate understanding of laboratory regulations (FDA, ISO, GLP, GMP) Experience with testing of pharmaceutical, cosmetic, and/or medical device products. Capabilities: Must be a detail-oriented, self-initiating individual with strong interpersonal written and oral communication skills. Strong organizational skills, and ability to multitask in a dynamic, fast-paced environment. Displays sound judgment and ambition; is quality focused; displays good communication skills; good implementation and follow-up skills. Hands-on experience and strong understanding of industry regulations and how to apply them including 21 CFR Part 11, 21 CFR Part 820, ISO 17025, USP, and GxP. Hands-on experience with CAPA, change control, quality events, and validation documentation (IQ/OQ/PQ). Strong problem-solving skills include root cause analysis using formal RCA tools such as Ishikawa and 5Ys. Additional Information Positions are full-time, working (Monday-Friday 8:00am-5:00pm), overtime as needed. Candidates currently living within commutable distance to North Brunswick Township, NJ are encouraged to apply. Compensation: $60,000-$78,000/year Excellent full time benefits including comprehensive medical coverage, dental, and vision options Life and disability insurance 401(k) with company match Paid vacation and holidays What Happens Next Our people are the backbone of what we do, so it's incredibly important we find the right individuals to join us. As a potential new recruit you'll be invited to meet the team in the form of an assessment centre or a staged interview process dependent on the role and it's requirements, this will give you the opportunity to see what working for Eurofins is really like and enable us to get you know your key skills and strengths. Your data As part of any recruitment process, the company collects and processes personal data relating to job applicants. The company is committed to being transparent about how it collects and uses that data and to meeting its data protection obligations. Closing Date We reserve the right to close or extend this position depending on application numbers. Therefore we would urge candidates to submit an application as early as possible. Due to the high volume of applications we receive please be aware that if you do not receive a response within 4 weeks of the vacancy expiry date unfortunately, on this occasion your application has been unsuccessful. Eurofins is a M/F, Disabled, and Veteran Equal Employment Opportunity and Affirmative Action employer. Eurofins USA BioPharma Services is a Disabled and Veteran Equal Employment Opportunity employer.
    $60k-78k yearly 5d ago
  • Quality Assurance Technician

    The Challenge Printing 4.4company rating

    Clifton, NJ jobs

    The Challenge Printing Company, established in 1911, is the premier provider of printed packaging components to the pharmaceutical industry. We are proud of our long-standing reputation for quality, innovation, and customer satisfaction.We are currently seeking motivated and reliable QA Technicians to join our team at the New Jersey location for full-time positions. This role is for the first shift, Monday through Friday, from 6:30 AM to 2:30 PM. The Primary Responsibilities are as following: · Perform thorough inspections of incoming materials and outgoing products. · Evaluate samples against standards by completing measurements, visual inspections, and other established tests. · Routinely test products to align temperature, specifications, and ingredient levels with best practices and quality standards. · Develop quality assurance plans by conducting hazard analyses, identifying critical control points and establishing critical limits. · Analyze test data to determine performance and reliability of materials · Achieve quality assurance operational objectives by preparing and implementing production, productivity and customer-service standards. · Help uncover and fix production problems in order to reduce overall defect rates.· Analyze technical drawings and manufacturers' instructions to troubleshoot problems in functional and control systems. · Adjust, repair and replace defective parts and materials. · Meet quality assurance financial objectives by estimating requirements, preparing budgets, scheduling expenditures and analyzing variances. · Partner on development of comprehensive quality assurance programs and local systems of care. · Monitor product standards and quality-control programs. Benefits: 401(k) 401(k) matching Dental insurance Disability insurance Health insurance Health savings account Life insurance Paid time off Vision insurance Requirements -High School diploma or equivalent required. · A minimum of 2 years' experience in a similar role · Ability to use Microsoft Office Suite (Excel, Word, Outlook, PowerPoint, Visio) · Experience with writing and enforcing standard operating procedures (SOPs) · Must be able to work in a team environment and be motivated to contribute efficiency and improvement ideas. · Ability to problem solve and create potential solutions. · Strong attention to detail and safety · Strong analytical and basic mathematics skills · Ability to communicate with all levels of management, both written and verbally · Ability to follow clear instructions and ask questions as needed · Must be able to lift up 35lbs
    $28k-40k yearly est. 5d ago
  • Pharmacovigilance Quality Assurance (PVQA) Specialist Contractor

    Shionogi 4.4company rating

    Florham Park, NJ jobs

    The PV Quality Assurance Specialist will provide operational support to the Pharmacovigilance / Patient Safety (PSPV) team in maintaining a compliant global PV system. The role is responsible for reviewing quality system documentation, supporting deviation and CAPA management, and contributing to inspection readiness activities. The individual will also provide subject matter expertise in Good Pharmacovigilance Practices (GVP), U.S. and international safety reporting requirements, and support ongoing quality initiatives within the PV Quality Management System (QMS). This is a hands-on, individual contributor assignment that emphasizes compliance support, operational execution, and cross-functional collaboration across Clinical, Regulatory, Safety, and QA teams. Responsibilities Reviews the global operational model of the Shionogi pharmacovigilance (PV) system and develops plans to establish a compliant PV system. Supports the implementation, execution and performance oversight of the Shionogi PV System for clinical and commercial operations. Reviews PV related Deviations, Quality Issues, CAPA, and supports their closure and Effectiveness Checks Assists in the preparation of KPIs for PV QMS performance monitoring and Management Oversight. Informs stakeholders on GVP/GCP Compliance Issues. Supports in ongoing Inspections Readiness efforts and during inspections. Reviews Standard Operating Procedures (SOPs), and other documentation and training materials related to GXP Compliance and other applicable requirements. Supports implementation of quality related projects as assigned. Qualifications Bachelor's Degree 3-5 years of relevant work experience in a PV QA related role for a pharmaceutical company (or equivalent combination of Drug Safety and Quality Assurance experience) Thorough knowledge of EU Good PharmacoVigilance Practices regulations (GVP) Strong knowledge of US and International Safety Reporting requirements Good Laboratory Practice (GLP) and Good Clinical Practice (GCP) knowledge, an asset Experience supporting deviation/CAPA management, audits, or inspections. Strong written and verbal communication skills; ability to collaborate across functions. Proficiency in Microsoft Office applications. Capabilities Ability to deliver clear, effective communication orally and in writing Assumes responsibility for successfully accomplishing work and has proven experience in delivering results Ability to work independently as well as in a team environment Attentive to the details, able to recognize critical attributes, steps and functions Well-organized, able to switch priorities quickly, coordinate several tasks at once and make quick informed decisions Thrives in an environment with tight deadlines and manages oneself with a sense of initiative and urgency Additional Information The hourly rate position is $48 - $70. Individual pay is determined by several factors, which include but are not limited to: job-related skills, experience, and relevant education or training. The range does not include the comprehensive benefits, bonus, long-term incentive, applicable allowances, or any additional compensation that may be associated with this role. EEO Shionogi Inc. is an equal opportunity employer supporting individuals with disabilities and veterans. All qualified applicants will receive equal consideration for employment opportunities based on valid job requirements without regard to race, color, religion, sex (including pregnancy), marital status, national origin, age, ancestry, citizenship, disability, genetic information, status as a disabled veteran, a recently separated veteran, Active Duty Wartime or Campaign Badge Veterans, and Armed Forces Service Medal Veterans, or any other characteristic protected by applicable law. It is the policy of Shionogi Inc. to undertake affirmative action for protected veterans and individuals with disabilities in compliance with all federal, state, and local requirements to recruit a diverse pool of protected veteran and individuals with disabilities applicants and to ensure that our employment practices are, in fact, non-discriminatory. If you are qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation if you are unable or limited in your ability to use or access this website to apply for a vacancy as a result of your disability. You can request accommodations by calling ************ or by sending an email to ***********************.
    $48-70 hourly Auto-Apply 4d ago
  • QA Medical Device Specialist II

    Sun Pharmaceuticals, Inc. 4.6company rating

    Princeton, NJ jobs

    Sun Pharma is the worlds fourth largest generics company with presence in Specialty, Generics and Consumer Healthcare products. Supported by more than 40 manufacturing facilities, we provide high-quality medicines, trusted by healthcare professionals and patients, to more than 100 countries across the globe. Over the last two decades, Sun Pharma has established itself as a leading player in the generics market in the U.S., and we are rapidly ramping up our presence in the specialty branded market with a focus on dermatology, ophthalmology and onco-dermatology. **Job Summary:** As a **QA Medical Device Specialist II** , you will support the QA Head in ensuring that all medical devices and combination productswhether manufactured in-house or by third-party partnersmeet rigorous quality standards. Youll play a key role in maintaining and enhancing our **Quality Management System (QMS)** , ensuring compliance with global regulatory requirements, and preparing the site for inspections and audits. **Area of Responsibility:** + Participate in **FDA, ISO, and other regulatory inspections** related to medical devices and combination products. + Ensure the **QMS** is compliant, effective, and aligned with corporate and regulatory standards. + Review **Device History Records (DHRs)** and ensure documentation accuracy. + Lead and support **continuous improvement initiatives** for QMS processes. + Investigate and resolve **quality complaints** and provide timely responses to customers. + Review and assess **vendor/supplier change notifications** and maintain the **Approved Supplier List (ASL)** . + Oversee **annual supplier assessments** , audit schedules, and vendor status tracking. + Manage and maintain documentation within **TrackWise** and other electronic systems. + Review and update **SOPs** to ensure alignment with FDA, ISO, EU MDR, and CMDR regulations. + Support internal audits and ensure **site readiness** for corporate and regulatory inspections. + Mentor junior team members and contribute to cross-functional collaboration. + Perform other duties as assigned. **Education and Experience:** + **Bachelors degree** in Life Sciences or a related field. + **24 years** of experience in a medical device or pharmaceutical manufacturing environment. + Strong working knowledge of: + **FDA regulations** : 21 CFR Part 4, 210/211, 820 + **International standards** : ISO 13485, EU MDR (2017/745), CMDR (SOR/98-282) + Experience with **TrackWise** , **EDMS** , **LMS** , and preferably **SAP** or **MasterControl** . + Familiarity with **radiopharmaceutical manufacturing and testing** is a plus. + Excellent verbal, written, and interpersonal communication skills. + Strong attention to detail and ability to work independently. + Proficient in **MS Office** and electronic quality systems. **Why Sun Pharma?** At Sun Pharma, youll be part of a mission-driven organization that values **quality, innovation, and collaboration** . We offer a dynamic work environment, opportunities for professional growth, and the chance to make a meaningful impact in the medical device and pharmaceutical industries. _Actual base compensation may vary based on a number of factors, including but not limited to geographical location and experience. In addition, this position is part of the Annual Performance Bonus Plan, and may be eligible for the_ _Long Term Incentive Plan_ _.Employees are eligible to participate in Company employee benefit programs which include medical, dental and vision coverage; life insurance; disability insurance; 401(k) savings plan; flexible spending accounts; and the employee assistance program. Employees also receive various paid time off benefits, including vacation time and sick time._ _The compensation and benefits described above are subject to the terms and conditions of any governing plans, policies, practices, agreements, or other materials or documents as in effect from time to time, including but not limited to terms and conditions regarding eligibility.If hired, employee will be in an at-will position and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company, or individual department/team performance, and market factors._ _The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of the incumbent(s)._ _We provide equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, military or veteran status, generic predisposing characteristics or any other basis prohibited by law._ **_Notice to Agency and Search Firm Representatives:_** _Sun Pharmaceuticals (Sun) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Sun employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Sun. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral._ We provide equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, military or veteran status, generic predisposing characteristics or any other basis prohibited by law.
    $73k-104k yearly est. 60d+ ago
  • Manufacturing Specialist - PFS - 1st Shift

    Hikma Pharmaceuticals 4.9company rating

    Cherry Hill, NJ jobs

    Job Title: Manufacturing Specialist - 1st Shift Job Type: Full-time About Us: As a developer, manufacturer, and supplier of essential medicines, Hikma Pharmaceuticals USA Inc. and its affiliates' purpose is to put better health within reach, every day for millions of patients around the world. We are a trusted, reliable partner and dependable source of over 760 high-quality generic, specialty and branded pharmaceutical products that hospitals, physicians and pharmacists need to treat their patients across North America, the Middle East, North Africa and Europe. Through our global footprint of 30+ manufacturing plants, 8+ R&D centers, and 9,000+ empowered employees, we are committed to making high-quality medicines accessible to the people who need them. KEY RESPONSIBILITES The Manufacturing Specialist will assist the shift lead in a hands-on approach to overseeing production activities including, filling, sterilization, component and equipment prep, and compounding. Completes quality systems activities including commitments, deviations, DCEs, and SOP revisions as necessary. Responsible for meeting budget, quality, and production goals, setting standards, and making employment and staffing recommendations. Interprets manufacturing policies, procedures, and programs * Qualified to work in and operate equipment in the assigned area of responsibility (i.e., ability to be gown qualified). * Assists the shift lead (supervisor) and Group Leader in ensuring production lines run efficiently and in a high state of compliance. * Completes deviations, commitments, DCEs, and SOP revisions as necessary. * Emphasize training and ensures training compliance. * Support and emphasize the Safety and Quality commitments of the department. * Analyze staffing needs. * Responsible for driving operational excellence projects. * Requires a B.S. in technical discipline with 0 to 3 years experience in manufacturing processes or 5 years experience in pharmaceutical injectables manufacturing as an alternative to a 4 year degree. * Sound knowledge and understanding of cGMPs. Ability to manage multiple priorities and projects. Must work well as a member of a team. Good oral and written communication skills. Ability to communicate well-written and oral. Compensation: Salary Range: $56,950 to $95,000.00. 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
    $30k-44k yearly est. Auto-Apply 18d ago
  • Quality Assurance Specialist I

    ANI Pharmaceuticals 4.4company rating

    Baudette, MN jobs

    About Us ANI Pharmaceuticals, Inc., headquartered near the beautiful shores of Lake of the Woods in Baudette, MN, is a diversified bio-pharmaceutical company serving patients in need by developing, manufacturing, and marketing high quality branded and generic prescription pharmaceutical products. About the Role This position is responsible for providing support to the Manufacturing and Packaging Operations to ensure relevant procedures are followed and meet GMP requirements. Position Responsibilities: Responsibilities include but are not limited to: Perform packaging line inspections/audits and provide assurance that packaging operations are compliant with applicable SOPs and cGMPs. Perform finished product attribute sample inspection and evaluation of finished products physical characteristics prior to packaging. Perform annual retain sample inspections and control finished product and raw material retain samples stored in the reserve sample room. Monitor GMP areas for compliance with general GMP requirements such as proper gowning and cleanliness, per CFR21 Subpart A General Provisions to assure they reflect current practices and meet industry standards and cGMP requirements. Perform other duties as assigned or requested. About You Bachelors degree is required. Chemistry, medical technology, microbiology preferred. Must have experience in a GMP environment, academic or otherwise. 1-2 years experience working within Quality Assurance preferred Experience following laboratory procedures and systems in Pharma or similarly regulated environment. Computer skills Previous work in a regulated environment Problem solving skills Ability to coordinate multiple tasks in a fast paced environment Ability to read and follow procedures Ability to work independently Attention to detail Excellent interpersonal skills Excellent organizational and follow through skills Excellent written and verbal communication skills Knowledge of GMPs Must be able to work within a team environment Must be able to work possible shift changes Must be able to travel occasionally Benefits & Perks Medical Dental Vision Life Insurance Short-Term Disability and Long-Term Disability Employee Assistance Program 401(k) Savings Plan Company Paid Holidays (10) Paid Time-Off Other Paid Leave Employee Stock Purchase Plan (ESPP) Opportunity to advance in company positions THE PERSON HIRED FOR THIS POSITION MUST BE ABLE TO RELOCATE TO BAUDETTE, MINNESOTA AT TIME OF HIRE The base salary range for this position is $48,000 - $52,000; the exact salary depends on various factors such as experience, skills, education, location, competencies and industry-specific knowledge. In addition, ANI Pharmaceuticals offers a variety of benefits to eligible employees, including health insurance coverage, life and disability insurance, retirement savings plans, paid leave programs, paid holidays and paid time off. Many of these benefits are subsidized or fully paid for by the company. Please note that ANI does not accept search agency or third-party emails, calls, or solicitations.
    $48k-52k yearly Auto-Apply 60d+ ago
  • Quality Assurance Specialist - 1st Shift - Environment Testing

    Eurofins Scientific 4.4company rating

    Lancaster, MN jobs

    Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins laboratories work with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic, and labelling is accurate. Eurofins is dedicated to delivering testing services that contribute to the health and safety of society and the planet, and to its corporate responsibility to protect the environment and ensure diversity, equity, and inclusion across the entire network of Eurofins companies. Job Description The Quality Assurance Specialist is responsible to support the Quality Assurance department and laboratory staff; assist with the certification processes (renewals, scope additions, Proficiency Test Sample tracking and reporting, etc.); process laboratory and client requests for information; maintain internal documentation for metrological testing of laboratory supplies/equipment; manage documentation in support of routine investigations and corrective action follow-up. Essential Duties and Responsibilities: * Applies GMP/GLP in all areas of responsibility, as appropriate * Demonstrates and promotes the company vision * Regular attendance and punctuality * Apply applicable current regulations based on assignment, such as EPA, TNI, PALA, * State/Regulatory programs, and ISO17025. * Perform all QA functions in compliance with quality policy and regulatory requirements * Manage Proficiency Testing program through ordering of PT samples, entry into LIMS, distribution to the laboratories and reporting of results. Initiate investigation requests for failed parameters. * Assist with submissions (applications, records, etc.) for maintenance of laboratory accreditations. * Perform transcription review as needed (i.e., PT entries, QAPP tables, accreditation scopes) * Maintain the list of ISO-Approved Suppliers * Make and communicate monthly SOP/forms review assignments for QA staff * Communicate monthly report deadlines to QA department, format monthly reports entries, distribute the report to management * Maintain metrological calibration records for balances, weights, thermometers, etc. * Coordinate the scheduling of these activities with the laboratories and the vendor * Help gather needed information for external audits * Support QA staff in performance of Data Miner electronic data audits by compiling initial data to be reviewed by the Senior/Principal Specialist * Review data reports from DI water monitoring, storage blanks, preservation checks, etc. * Issue investigation requests as needed. * Route investigations and audits once they have been approved and closed by designated QA staff. File routing documentation within the investigation database * Work with Client Services department to organize and approve subcontract laboratories: sending requests for information, tracking responses, etc. * Use opportunities to contribute to continuous quality and process improvement of QA department and of the laboratories * Monitor the QA Group email Inbox; assign individuals to requests as needed based on area of representation. * Maintain inventory of office supplies for the department; submit supply orders as needed * Conducts all activities in a safe and efficient manner. Follow all required safety protocols. * Performs other duties as assigned Role is full time, 1st shift, M-F 9:00am-5:00pm. Qualifications Basic Minimum Qualifications: * Bachelor's degree in Chemistry, or other science-related field of study * Computer skills, including proficiency with Microsoft Office * Professional working proficiency in English is a requirement, including the ability to read, write and speak in English. * Authorization to work in the United States without restriction or sponsorship Ideal Candidates will have: * Previous experience working in quality in a lab or similar setting * Motivation to be accurate and produce high quality work with minimal supervision * Planning, organization, work management (multi-tasking) and follow-up skills * Quality-orientation with high attention to detail * Effective written and verbal communication skills * Computer literacy with Windows-based programs; MS Office, office equipment, and good typing skills. * Ability to accept changes in schedules and versatility of workload; willingness to adjust to corporate needs * Ability to follow detailed verbal and written instructions * A clear understanding of priorities Additional Information Pay rate: $20/hr Please note - Eurofins Environment Testing (USA) provides a compensation range for informational purposes, the actual base salary may vary based upon, but not limited to, relevant experience and skill set, base salary of internal peers, business sector, and geographic location. As a Eurofins employee, you will become part of a company that has received national recognition as a great place to work. We offer excellent full-time benefits including comprehensive medical coverage, life and disability insurance, 401(k) with company match, paid holidays, paid time off, and dental and vision options. We support your development! Do you feel you don't match 100% of the requirements? Don't hesitate to apply anyway! Eurofins companies are committed to supporting your career development. We embrace diversity! Eurofins network of companies believe in strength and innovation through diversity, being an Equal Opportunity Employer. We prohibit discrimination against employees or applications based on gender identity and/or expression, race, nationality, age, religion, sexual orientation, disability, and everything else that makes employees of Eurofins companies unique. Sustainability matters to us! We are well on our way to achieving our objective of carbon neutrality by 2025, through a combination of emission reduction and compensation initiatives. We encourage our laboratory leaders to make sustainable changes at their local level, and in addition to their initiatives we also count on our dedicated carbon reduction team to help us to achieve this goal! Find out more in our career page: ***************************** Company description: Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins laboratories work with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate. The Eurofins network of companies is the global leader in food, environment, pharmaceutical and cosmetic product testing and in discovery pharmacology, forensics, advanced material sciences and Eurofins Scientific 2/2 March 2023 agroscience contract research services. It is one of the market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, advanced material sciences and in the support of clinical studies, as well as having an emerging global presence in Contract Development and Manufacturing Organizations. It also has a rapidly developing presence in highly specialized and molecular clinical diagnostic testing and in-vitro diagnostic products. In over 35 years, Eurofins has grown from one laboratory in Nantes, France to 61,000 staff across a decentralized and entrepreneurial network of ca. 900 laboratories in 61 countries. Eurofins companies offer a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products. In 2022, Eurofins generated total revenues of EUR 6.7 billion, and has been among the best performing stocks in Europe over the past 20 years. Eurofins USA Environment Testing is a Disabled and Veteran Equal Employment Opportunity employer.
    $20 hourly 26d ago
  • Quality Assurance Inspector - 2nd Shift

    Amneal Pharmaceuticals, Inc. 4.6company rating

    Piscataway, NJ jobs

    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 5d ago
  • Quality Assurance Inspector II

    Amneal Pharmaceuticals, Inc. 4.6company rating

    Branchburg, NJ jobs

    To monitor and ensure 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. 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: * All Functions of QA Inspector I, Perform Inspection, sampling and testing where applicable on all incoming raw materials, packaging components and returned goods following detailed written procedures. * Preparation of samples for chemical and microbiological (where required) analysis and delivering them to the QC lab. * Inspection and test of packaging components utilizing various measuring devices such as scales, micrometers and height gauges to determine conformance to specifications. * Maintaining detailed records of sampling, inspections and testing activities. * Assigning and verification of expiry date and retest date for all the GMP raw materials through vendor COA and in-house COA. * Collection of 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. * Maintenance of standard weights required to perform daily verification of balances. * Labeling component receipt, visual examination, counting, preliminary inspection and sampling. * Preparation of labeling components/outserts inspection reports; quarantine and release labels and maintaining incoming components log and corresponding inventory cards. * Issuance of labeling components/outserts according to packaging order and regular monitoring and auditing of label room. * Fill out the QA final labeled product inspection report, final line clearance which includes labeling and packaging reconciliation paperwork. * Compliance of Warehouse area in terms of Isolation of Quarantine, Released, In-Process, Finished Product, Packaged Product, Returned Goods, and Rejected areas. * Ensure the proper isolation of rejected material generated during batch process and accountability in the batch record. Monitor facility and product environmental operating conditions. * Plus the following: * Review of engineering records (temperature and humidity data calibration and PM records, Pest control records and contractor related functions) * Review of online batch records in terms of completeness of signatures, entries, and actual reconciliation / yields prior to initiation of next processing step * Verification of functionality of all the equipment and associated controls during the batch run * Maintenance of retention sample room and monitoring of temperature and humidity, replacement of chart records as per schedule, review of log 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 from time to time assign.
    $41k-54k yearly est. Auto-Apply 59d ago
  • Engineering Technician II

    Cretex 4.0company rating

    Coon Rapids, MN jobs

    The Engineering Technician II will work alongside Manufacturing Engineers supporting technical operations in a high-volume medical device contract manufacturing facility. This person is directly responsible for assembling prototypes, executing test protocols, documenting results, evaluating new manufacturing process instructions, and providing feedback to the engineering and manufacturing teams. This position will also assist with developing and maintaining tooling and fixtures. Essential Job Functions * First point of contact for technical support escalation for operations * Provide assembly process feedback to the engineering team * Responsible to monitor, inspect, setup, calibrate, and maintain manufacturing process equipment * Research and identify manufacturing or engineering solutions * Diagnose and troubleshoot technical issues, including but not limited to, machining, injection molding, laser processing, stamping, or packaging * Assist engineers as they create, modify, and test products and processes * Inspect products and processes for flaws and identify areas of improvement * Conduct tests and collect data in support of validation activities * Utilize and uses computer-aided design and drafting software * Develops production drawings for manufacturing * Reads and complies with work instructions, set up sheets, and checklists * Enters production information into the ERP system on a timely basis * Generate ECO/DCO and process documentation changes related to manufacturing changes, such as work instruction changes, print changes, documentation updates, etc. * Perform equipment set-ups as required * Support and comply with the company Quality System, ISO, and medical device requirements * Read, understand, and follow work instructions and standard work * Partner with other business segments: sales/marketing, customer service, engineering, quality, and finance * Understand customer needs and the core business markets we serve * Ensure business systems are implemented, maintained, and functioning properly * Participate in required company meetings * Maintain an organized work area (5S) * Participate in the Operational Excellence Program * Complete all other work duties as assigned * Ability to work in a manufacturing environment Minimum Requirements, Education & Experience (incl. KSA's and certifications) * 3 years of experience working as an engineering technician * Knowledge of Good Manufacturing Practices & Quality Systems Regulations is desirable * Medical product experience * Must have good communication and documentation skills * Must have problem solving and critical thinking skills * Working knowledge of CAD software platforms AutoCAD, SolidWorks, or Pro-E experience is desired. * Ability to cross train in other areas of production when required * Microsoft Office proficiency (Outlook, Word, Excel, PowerPoint, Publisher) * Clear and effective verbal and written communication skills * Attention to detail * PLC, Python, Vision Systems programming exposure * Ability to work in a fast-paced team environment * Ability to prioritize and multitask Desirable Criteria & Qualifications * Associate Degree in Engineering * 3-5 years of engineering experience Responsibilities Position summary The Engineering Technician will work alongside Manufacturing Engineers supporting technical operations in a high-volume medical device contract manufacturing facility. This person is directly responsible for assembling prototypes, executing test protocols, documenting results, evaluating new manufacturing process instructions, and providing feedback to the engineering and manufacturing teams. In addition, the person will assist with developing and maintaining tooling, fixtures, and a clean and well organized engineering lab space. Essential Job Functions First point of contact for technical support escalation for operations Provide assembly process feedback to the engineering team Responsible to monitor, inspect, setup, calibrate, and maintain manufacturing process equipment Research and identify solutions to manufacturing or engineering issues Diagnose and troubleshoot technical issues, including but not limited, machining, injection molding, laser processing, stamping or packaging Assist engineers as they create, modify, and test products and processes Inspect products and processes for flaws and identify areas of improvement Conduct tests and collect data in support of validation activities Utilize and uses computer-aided design and drafting software Develops production drawings for manufacturing Reads and complies with work instructions, set up sheets, and checklists Enters production information into the ERP system on a timely basis Generate ECO/DCO and process documentation changes related to manufacturing changes, such as work instruction changes, print changes, documentation updates, etc. Perform equipment set-ups as required Maintains an organized work area (5S) to include workstations, equipment, walkways, and locker rooms Participates in the Operational Excellence Program Understands and complies with the Cretex professional competencies, company policies, and employee manual Adheres to all safety policies; includes wearing personal protective equipment when required Supports and complies with the company s Quality System, ISO, and medical device requirements Completes all other work duties as assigned Minimum Requirements, Education & Experience (incl. KSA s and certifications) Minimum 3 years of experience working as an engineering technician Knowledge of Good Manufacturing Practices & Quality Systems Regulations is desirable Prefer medical product experience Must have good communication and documentation skills Must have problem solving and critical thinking skills Working knowledge of CAD software platforms AutoCAD, SolidWorks, or Pro-E experience is desired Pay Range USD $25.00 - USD $35.00 /Yr. Pay Range Details This pay range reflects the base hourly rate or annual salary for positions within this job grade, based on our market-based pay structures. Actual compensation will depend on factors such as skills, relevant experience, education, internal equity, business needs, and local market conditions. While the full hiring range is shared for transparency, offers are rarely made at the minimum or maximum of the range. Company Benefits All Employees: Our 401k retirement savings plan with a company match contribution; onsite health clinics, discretionary holiday bonus program (based on years of service), Cretex University, 24/7 employee assistance program with access to five confidential visits with a licensed counselor at no cost, wellness program with incentives, an employee death benefit, and employee sick and safe leave are available to all Cretex employees. 20+hours: Cretex's medical benefit package includes: comprehensive medical insurance with access to virtual providers; dental insurance (Little Partners Dental benefit covers services 100 percent for children 12 and younger when seen by a Health Partners in network provider); vision insurance; a pre-tax health savings account, healthcare and dependent care pre-tax reimbursement accounts; paid holidays, paid time off; and our discretionary profit sharing program are available to employees working 20+ hours/week. 30+ hours: Parental Leave, accident and critical illness benefits, optional employee, spouse, and child life; short and long term disability; company provided life insurance; and tuition assistance programs are available to employees working 30+ hours per week. (Some benefits are subject to eligibility criteria.) Applicants will receive consideration for employment regardless of their race, color, creed, religion, national origin, sex, sexual orientation, gender identity, disability, age, veteran status, marital status, family status, status with regard to public assistance, or any other protected status as required by law. Our company uses E-Verify to confirm the employment and eligibility of all newly hired employees. To learn more about E-Verify, including your rights and responsibilities, please visit *********************
    $25-35 hourly Auto-Apply 1d ago
  • Production Technician I - Post Compounding 3rd Shift

    QuVa Pharma 4.5company rating

    Quality assurance technician job at QuVa Pharma

    Our Production Technician I - Post Compounding plays a vital role in ensuring the highest quality and safety standards of our pharmaceutical products. Once you complete our training, your responsibilities will include supporting daily manufacturing activities for non-sterile and sterile bulk/CSP operations. Your attention to detail and adherence to precise procedures will guarantee that our medications reach patients accurately and securely. Turn your passion for precision and your commitment to quality into a meaningful impact on healthcare across the US. This is a full-time role for our 3rd shift, working Monday through Friday from 10:00 PM to 6:30 AM. This is a set, consistent schedule with minimum overtime requirements and based on site in our Sugar Land, TX location. This is a safety sensitive position that may be subject to random drug testing, in accordance with applicable laws. What the Post Compounding Technician Does Each Day: * Perform line clearances, assure equipment is operating correctly, and assure Post Compounding checks are performed * Ensures proper cleaning of the equipment in accordance with procedures * Monitors the daily use of Controlled and Non-Controlled Substances throughout the process to assure people and processes * Completes in-process checks & verifications of Controlled and Non-Controlled Substances in alignment with Standard Operating Procedures * Reviews documentation, such as batch records, to ensure recording of processes, logs, and accounting of materials is in compliance with policies, procedures, and Good Documentation Practices (GDP) Our Most Successful Post Compounding Technicians: * Enjoy working independently * Carefully follow clear directions to ensure safety and accuracy * Are detail-oriented and take careful notes * Support others when needed with activities like cleaning, stocking, etc. * Take initiative to identify problems and opportunities Minimum Requirements for this Role: * A High School diploma or equivalent * Able to successfully complete a background check * Able and willing to walk, stoop, stand, bend, and lift up to 50 lbs. throughout each shift, with or without reasonable accommodation * Able and willing to follow strict clothing and accessory rules to support our sterile operating environment * Familiarity with and comfortable using mobile devices such as smartphones, tablets, handhelds * 18+ years of age * Must be currently authorized to work in the United States on a full-time basis; Quva will not sponsor applicants for work visas Any of the Following Will Give You an Edge: * Experience in a role requiring repetitive tasks, attention to detail and individualized work - such as working in a warehouse or manufacturing environment * Experience in a pharmaceutical manufacturing environment * Working in or around a sterile "cleanroom" Benefits of Working at Quva: * Set, full-time, consistent work schedule * Comprehensive health and wellness benefits including medical, dental and vision * 401k retirement program with company match * 17 paid days off plus 8 paid holidays per year * Occasional weekend and overtime opportunities with advance notice * National, industry-leading high growth company with future career advancement opportunities About Quva: Quva is a national, industry-leading provider of compounded injectable medicines and software solutions that help power the business of hospital and health-system pharmacy. Quva Pharma produces and distributes injectable medicines required by health care providers and critical to patient care. Quva BrightStream partners with health-systems to analyze large amounts of data and through AI and machine learning, develops software solutions that turns the data into insights that are used to better run their pharmacy operation. Quva's overall product and technology offerings help health-systems achieve greater value and deliver the highest-quality patient care. Quva is an equal opportunity employer and is committed to creating and maintaining a work environment that is free from all forms of discrimination and harassment. Quva's Equal Opportunity Policy prohibits harassment or discrimination due to age, ancestry, color, disability, gender, gender expression, gender identity, genetic information, marital status, medical condition, military or veteran status, national origin, race, religious creed, sex (including pregnancy, childbirth, breastfeeding, and any related medical conditions), sexual orientation, and any other characteristic or classification protected by applicable laws. All employment with Quva is "at will."
    $21k-32k yearly est. 30d ago
  • Engineering Technician II 1st shift

    Cretex 4.0company rating

    Brooklyn Park, MN jobs

    Medical Cretex Medical is a leading contract manufacturer of precision components and assemblies for the medical device industry. Our customers view us as a trusted partner in the areas of injection molding, laser processing, metal stamping and device assembly. Learn more at ********************** Position Summary: The Engineering Technician II will work alongside Manufacturing Engineers supporting technical operations in a high-volume medical device contract manufacturing facility. This person is directly responsible for assembling prototypes, executing test protocols, documenting results, evaluating new manufacturing process instructions, and providing feedback to the engineering and manufacturing teams. This position will also assist with developing and maintaining tooling and fixtures and will focus on varius catheter process development and manufacturing processes. This position is in our Brooklyn Park facility. Responsibilities * First point of contact for technical support escalation for operations• Provide assembly process feedback to the engineering team• Responsible to monitor, inspect, setup, calibrate, and maintain manufacturing process equipment• Research and identify manufacturing or engineering solutions • Diagnose and troubleshoot technical issues, including but not limited to, machining, injection molding, laser processing, stamping, or packaging • Assist engineers as they create, modify, and test products and processes• Inspect products and processes for flaws and identify areas of improvement• Conduct tests and collect data in support of validation activities• Utilize and uses computer-aided design and drafting software• Develops production drawings for manufacturing • Reads and complies with work instructions, set up sheets, and checklists• Enters production information into the ERP system on a timely basis• Generate ECO/DCO and process documentation changes related to manufacturing changes, such as work instruction changes, print changes, documentation updates, etc.• Perform equipment set-ups as required• Support and comply with the company Quality System, ISO, and medical device requirements• Read, understand, and follow work instructions and standard work• Partner with other business segments: sales/marketing, customer service, engineering, quality, and finance Qualifications * 3 years of experience working as an engineering technician * Hands on experience building medical catheters using typical assembly techniques and equipment strongly preferred * Experience with catheter assembly * Experience facilitating, executing and documenting process characterization and validation studies * Demonstrate ability to execute process improvement * Knowledge of Good Manufacturing Practices & Quality Systems Regulations is desirable * Medical product experience * Must have good communication and documentation skills * Must have problem solving and critical thinking skills * Working knowledge of CAD software platforms AutoCAD, SolidWorks, or Pro-E experience is desired. * Ability to cross train in other areas of production when required * Microsoft Office proficiency (Outlook, Word, Excel, PowerPoint, Publisher) * Clear and effective verbal and written communication skills * Attention to detail * Organizational skills * Ability to work in a fast-paced team environment * Ability to prioritize and multitask Desirable Criteria and Qualifications * Associate Degree in Engineering • 3-5 years of engineering experience What is it like to work at Cretex Medical? We recognize the contribution of every individual and promote growth, safety and security for all our employees. Cretex Medical values performance and pays competitive wages along with a rich benefit package. We offer a positive work environment with a focus on continuous improvement. Here are some of things that employees have said about working for Cretex Medical: * "The culture at Cretex is collaborative. Everyone here is willing to help you whether it is a director, a machinist, or your boss. Everyone is always willing to help you figure out a project and get it done right." * "I would tell potential interns that Cretex is a great company to work for. It has set a high bar for corporate culture as well as the quality of work you can do. I would definitely recommend it." * "I learned that I really like the medical device industry. The importance and the gravity of what we do here is felt by the employees. You can have that passion in your work because you know what you are striving for is to save lives." We encourage you to explore the many opportunities Cretex Medical can offer you as a valued team member. Pay Range USD $24.66 - USD $35.72 /Hr. Pay Range Details This pay range reflects the base hourly rate or annual salary for positions within this job grade, based on our market-based pay structures. Actual compensation will depend on factors such as skills, relevant experience, education, internal equity, business needs, and local market conditions. While the full hiring range is shared for transparency, offers are rarely made at the minimum or maximum of the range. Company Benefits All Employees: Our 401k retirement savings plan with a company match contribution; onsite health clinics, discretionary holiday bonus program (based on years of service), Cretex University, 24/7 employee assistance program with access to five confidential visits with a licensed counselor at no cost, wellness program with incentives, an employee death benefit, and employee sick and safe leave are available to all Cretex employees. 20+hours: Cretex's medical benefit package includes: comprehensive medical insurance with access to virtual providers; dental insurance (Little Partners Dental benefit covers services 100 percent for children 12 and younger when seen by a Health Partners in network provider); vision insurance; a pre-tax health savings account, healthcare and dependent care pre-tax reimbursement accounts; paid holidays, paid time off; and our discretionary profit sharing program are available to employees working 20+ hours/week. 30+ hours: Parental Leave, accident and critical illness benefits, optional employee, spouse, and child life; short and long term disability; company provided life insurance; and tuition assistance programs are available to employees working 30+ hours per week. (Some benefits are subject to eligibility criteria.) Applicants will receive consideration for employment regardless of their race, color, creed, religion, national origin, sex, sexual orientation, gender identity, disability, age, veteran status, marital status, family status, status with regard to public assistance, or any other protected status as required by law. Our company uses E-Verify to confirm the employment and eligibility of all newly hired employees. To learn more about E-Verify, including your rights and responsibilities, please visit *********************
    $24.7-35.7 hourly Auto-Apply 60d+ ago
  • Engineering Technician II 1st shift

    Cretex 4.0company rating

    Brooklyn Park, MN jobs

    Medical Cretex Medical is a leading contract manufacturer of precision components and assemblies for the medical device industry. Our customers view us as a trusted partner in the areas of injection molding, laser processing, metal stamping and device assembly. Learn more at ********************** Position Summary: The Engineering Technician II will work alongside Manufacturing Engineers supporting technical operations in a high-volume medical device contract manufacturing facility. This person is directly responsible for assembling prototypes, executing test protocols, documenting results, evaluating new manufacturing process instructions, and providing feedback to the engineering and manufacturing teams. This position will also assist with developing and maintaining tooling and fixtures and will focus on varius catheter process development and manufacturing processes. This position is in our Brooklyn Park facility. Responsibilities • First point of contact for technical support escalation for operations • Provide assembly process feedback to the engineering team • Responsible to monitor, inspect, setup, calibrate, and maintain manufacturing process equipment • Research and identify manufacturing or engineering solutions • Diagnose and troubleshoot technical issues, including but not limited to, machining, injection molding, laser processing, stamping, or packaging • Assist engineers as they create, modify, and test products and processes • Inspect products and processes for flaws and identify areas of improvement • Conduct tests and collect data in support of validation activities • Utilize and uses computer-aided design and drafting software • Develops production drawings for manufacturing • Reads and complies with work instructions, set up sheets, and checklists • Enters production information into the ERP system on a timely basis • Generate ECO/DCO and process documentation changes related to manufacturing changes, such as work instruction changes, print changes, documentation updates, etc. • Perform equipment set-ups as required • Support and comply with the company Quality System, ISO, and medical device requirements • Read, understand, and follow work instructions and standard work • Partner with other business segments: sales/marketing, customer service, engineering, quality, and finance Qualifications 3 years of experience working as an engineering technician Hands on experience building medical catheters using typical assembly techniques and equipment strongly preferred Experience with catheter assembly Experience facilitating, executing and documenting process characterization and validation studies Demonstrate ability to execute process improvement Knowledge of Good Manufacturing Practices & Quality Systems Regulations is desirable Medical product experience Must have good communication and documentation skills Must have problem solving and critical thinking skills Working knowledge of CAD software platforms AutoCAD, SolidWorks, or Pro-E experience is desired. Ability to cross train in other areas of production when required Microsoft Office proficiency (Outlook, Word, Excel, PowerPoint, Publisher) Clear and effective verbal and written communication skills Attention to detail Organizational skills Ability to work in a fast-paced team environment Ability to prioritize and multitask Desirable Criteria and Qualifications • Associate Degree in Engineering • 3-5 years of engineering experience What is it like to work at Cretex Medical? We recognize the contribution of every individual and promote growth, safety and security for all our employees. Cretex Medical values performance and pays competitive wages along with a rich benefit package. We offer a positive work environment with a focus on continuous improvement. Here are some of things that employees have said about working for Cretex Medical: “The culture at Cretex is collaborative. Everyone here is willing to help you whether it is a director, a machinist, or your boss. Everyone is always willing to help you figure out a project and get it done right.” “I would tell potential interns that Cretex is a great company to work for. It has set a high bar for corporate culture as well as the quality of work you can do. I would definitely recommend it.” “I learned that I really like the medical device industry. The importance and the gravity of what we do here is felt by the employees. You can have that passion in your work because you know what you are striving for is to save lives.” We encourage you to explore the many opportunities Cretex Medical can offer you as a valued team member. Pay Range USD $24.66 - USD $35.72 /Hr. Pay Range Details This pay range reflects the base hourly rate or annual salary for positions within this job grade, based on our market-based pay structures. Actual compensation will depend on factors such as skills, relevant experience, education, internal equity, business needs, and local market conditions. While the full hiring range is shared for transparency, offers are rarely made at the minimum or maximum of the range. Company Benefits All Employees: Our 401k retirement savings plan with a company match contribution; onsite health clinics, discretionary holiday bonus program (based on years of service), Cretex University, 24/7 employee assistance program with access to five confidential visits with a licensed counselor at no cost, wellness program with incentives, an employee death benefit, and employee sick and safe leave are available to all Cretex employees. 20+hours: Cretex's medical benefit package includes: comprehensive medical insurance with access to virtual providers; dental insurance (Little Partners Dental benefit covers services 100 percent for children 12 and younger when seen by a Health Partners in network provider); vision insurance; a pre-tax health savings account, healthcare and dependent care pre-tax reimbursement accounts; paid holidays, paid time off; and our discretionary profit sharing program are available to employees working 20+ hours/week. 30+ hours: Parental Leave, accident and critical illness benefits, optional employee, spouse, and child life; short and long term disability; company provided life insurance; and tuition assistance programs are available to employees working 30+ hours per week. (Some benefits are subject to eligibility criteria.) Applicants will receive consideration for employment regardless of their race, color, creed, religion, national origin, sex, sexual orientation, gender identity, disability, age, veteran status, marital status, family status, status with regard to public assistance, or any other protected status as required by law. Our company uses E-Verify to confirm the employment and eligibility of all newly hired employees. To learn more about E-Verify, including your rights and responsibilities, please visit *********************
    $24.7-35.7 hourly Auto-Apply 17d ago
  • Engineering Technician 1st shift

    Cretex 4.0company rating

    Dassel, MN jobs

    Medical Cretex Medical is a leading contract manufacturer of precision components and assemblies for the medical device industry. Our customers view us as a trusted partner in the areas of injection molding, laser processing, metal stamping and device assembly. Learn more at ********************** Position Summary: The Engineering Technician will work alongside Manufacturing Engineers supporting technical operations in a high-volume medical device contract manufacturing facility. This person is directly responsible for assembling prototypes, executing test protocols, documenting results, evaluating new manufacturing process instructions, and providing feedback to the engineering and manufacturing teams. This position will also assist with developing and maintaining tooling and fixtures. Position is open to Engineering Tech I or Engineering Tech II (based on experience) Responsibilities * First point of contact for technical support escalation for operations• Provide assembly process feedback to the engineering team• Responsible to monitor, inspect, setup, calibrate, and maintain manufacturing process equipment• Research and identify manufacturing or engineering solutions • Diagnose and troubleshoot technical issues, including but not limited to, machining, injection molding, laser processing, stamping, or packaging • Assist engineers as they create, modify, and test products and processes• Inspect products and processes for flaws and identify areas of improvement• Conduct tests and collect data in support of validation activities• Utilize and uses computer-aided design and drafting software• Develops production drawings for manufacturing • Reads and complies with work instructions, set up sheets, and checklists• Enters production information into the ERP system on a timely basis• Generate ECO/DCO and process documentation changes related to manufacturing changes, such as work instruction changes, print changes, documentation updates, etc.• Perform equipment set-ups as required• Support and comply with the company Quality System, ISO, and medical device requirements• Read, understand, and follow work instructions and standard work• Partner with other business segments: sales/marketing, customer service, engineering, quality, and finance Qualifications * 3 years of experience working as an engineering technician (Engineering Technician Level II) * Prior chemical handling experience strongly preferred * Knowledge of Good Manufacturing Practices & Quality Systems Regulations is desirable * Medical product experience * Must have good communication and documentation skills * Must have problem solving and critical thinking skills * Working knowledge of CAD software platforms AutoCAD, SolidWorks, or Pro-E experience is desired. * Ability to cross train in other areas of production when required * Microsoft Office proficiency (Outlook, Word, Excel, PowerPoint, Publisher) * Clear and effective verbal and written communication skills * Attention to detail * Organizational skills * Ability to work in a fast-paced team environment * Ability to prioritize and multitask Desirable Criteria and Qualifications * Associate Degree in Engineering • 3-5 years of engineering experience What is it like to work at Cretex Medical? We recognize the contribution of every individual and promote growth, safety and security for all our employees. Cretex Medical values performance and pays competitive wages along with a rich benefit package. We offer a positive work environment with a focus on continuous improvement. Here are some of things that employees have said about working for Cretex Medical: * "The culture at Cretex is collaborative. Everyone here is willing to help you whether it is a director, a machinist, or your boss. Everyone is always willing to help you figure out a project and get it done right." * "I would tell potential interns that Cretex is a great company to work for. It has set a high bar for corporate culture as well as the quality of work you can do. I would definitely recommend it." * "I learned that I really like the medical device industry. The importance and the gravity of what we do here is felt by the employees. You can have that passion in your work because you know what you are striving for is to save lives." We encourage you to explore the many opportunities Cretex Medical can offer you as a valued team member. Pay Range USD $22.40 - USD $35.72 /Hr. Pay Range Details This pay range reflects the base hourly rate or annual salary for positions within this job grade, based on our market-based pay structures. Actual compensation will depend on factors such as skills, relevant experience, education, internal equity, business needs, and local market conditions. While the full hiring range is shared for transparency, offers are rarely made at the minimum or maximum of the range. Company Benefits All Employees: Our 401k retirement savings plan with a company match contribution; onsite health clinics, discretionary holiday bonus program (based on years of service), Cretex University, 24/7 employee assistance program with access to five confidential visits with a licensed counselor at no cost, wellness program with incentives, an employee death benefit, and employee sick and safe leave are available to all Cretex employees. 20+hours: Cretex's medical benefit package includes: comprehensive medical insurance with access to virtual providers; dental insurance (Little Partners Dental benefit covers services 100 percent for children 12 and younger when seen by a Health Partners in network provider); vision insurance; a pre-tax health savings account, healthcare and dependent care pre-tax reimbursement accounts; paid holidays, paid time off; and our discretionary profit sharing program are available to employees working 20+ hours/week. 30+ hours: Parental Leave, accident and critical illness benefits, optional employee, spouse, and child life; short and long term disability; company provided life insurance; and tuition assistance programs are available to employees working 30+ hours per week. (Some benefits are subject to eligibility criteria.) Applicants will receive consideration for employment regardless of their race, color, creed, religion, national origin, sex, sexual orientation, gender identity, disability, age, veteran status, marital status, family status, status with regard to public assistance, or any other protected status as required by law. Our company uses E-Verify to confirm the employment and eligibility of all newly hired employees. To learn more about E-Verify, including your rights and responsibilities, please visit *********************
    $22.4-35.7 hourly Auto-Apply 11d ago
  • Engineering Technician II 1st shift

    Cretex 4.0company rating

    Dassel, MN jobs

    Medical Cretex Medical is a leading contract manufacturer of precision components and assemblies for the medical device industry. Our customers view us as a trusted partner in the areas of injection molding, laser processing, metal stamping and device assembly. Learn more at ********************** Position Summary: The Engineering Technician II will work alongside Manufacturing Engineers supporting technical operations in a high-volume medical device contract manufacturing facility. This person is directly responsible for assembling prototypes, executing test protocols, documenting results, evaluating new manufacturing process instructions, and providing feedback to the engineering and manufacturing teams. This position will also assist with developing and maintaining tooling and fixtures. Responsibilities * First point of contact for technical support escalation for operations• Provide assembly process feedback to the engineering team• Responsible to monitor, inspect, setup, calibrate, and maintain manufacturing process equipment• Research and identify manufacturing or engineering solutions • Diagnose and troubleshoot technical issues, including but not limited to, machining, injection molding, laser processing, stamping, or packaging • Assist engineers as they create, modify, and test products and processes• Inspect products and processes for flaws and identify areas of improvement• Conduct tests and collect data in support of validation activities• Utilize and uses computer-aided design and drafting software• Develops production drawings for manufacturing • Reads and complies with work instructions, set up sheets, and checklists• Enters production information into the ERP system on a timely basis• Generate ECO/DCO and process documentation changes related to manufacturing changes, such as work instruction changes, print changes, documentation updates, etc.• Perform equipment set-ups as required• Support and comply with the company Quality System, ISO, and medical device requirements• Read, understand, and follow work instructions and standard work• Partner with other business segments: sales/marketing, customer service, engineering, quality, and finance Qualifications * 3 years of experience working as an engineering technician• Knowledge of Good Manufacturing Practices & Quality Systems Regulations is desirable• Medical product experience• Must have good communication and documentation skills• Must have problem solving and critical thinking skills• Working knowledge of CAD software platforms AutoCAD, SolidWorks, or Pro-E experience is desired. • Ability to cross train in other areas of production when required• Microsoft Office proficiency (Outlook, Word, Excel, PowerPoint, Publisher)• Clear and effective verbal and written communication skills • Attention to detail• Organizational skills • Ability to work in a fast-paced team environment• Ability to prioritize and multitask Desirable Criteria and Qualifications * Associate Degree in Engineering • 3-5 years of engineering experience What is it like to work at Cretex Medical? We recognize the contribution of every individual and promote growth, safety and security for all our employees. Cretex Medical values performance and pays competitive wages along with a rich benefit package. We offer a positive work environment with a focus on continuous improvement. Here are some of things that employees have said about working for Cretex Medical: * "The culture at Cretex is collaborative. Everyone here is willing to help you whether it is a director, a machinist, or your boss. Everyone is always willing to help you figure out a project and get it done right." * "I would tell potential interns that Cretex is a great company to work for. It has set a high bar for corporate culture as well as the quality of work you can do. I would definitely recommend it." * "I learned that I really like the medical device industry. The importance and the gravity of what we do here is felt by the employees. You can have that passion in your work because you know what you are striving for is to save lives." We encourage you to explore the many opportunities Cretex Medical can offer you as a valued team member. Pay Range USD $24.66 - USD $35.72 /Hr. Pay Range Details This pay range reflects the base hourly rate or annual salary for positions within this job grade, based on our market-based pay structures. Actual compensation will depend on factors such as skills, relevant experience, education, internal equity, business needs, and local market conditions. While the full hiring range is shared for transparency, offers are rarely made at the minimum or maximum of the range. Company Benefits All Employees: Our 401k retirement savings plan with a company match contribution; onsite health clinics, discretionary holiday bonus program (based on years of service), Cretex University, 24/7 employee assistance program with access to five confidential visits with a licensed counselor at no cost, wellness program with incentives, an employee death benefit, and employee sick and safe leave are available to all Cretex employees. 20+hours: Cretex's medical benefit package includes: comprehensive medical insurance with access to virtual providers; dental insurance (Little Partners Dental benefit covers services 100 percent for children 12 and younger when seen by a Health Partners in network provider); vision insurance; a pre-tax health savings account, healthcare and dependent care pre-tax reimbursement accounts; paid holidays, paid time off; and our discretionary profit sharing program are available to employees working 20+ hours/week. 30+ hours: Parental Leave, accident and critical illness benefits, optional employee, spouse, and child life; short and long term disability; company provided life insurance; and tuition assistance programs are available to employees working 30+ hours per week. (Some benefits are subject to eligibility criteria.) Applicants will receive consideration for employment regardless of their race, color, creed, religion, national origin, sex, sexual orientation, gender identity, disability, age, veteran status, marital status, family status, status with regard to public assistance, or any other protected status as required by law. Our company uses E-Verify to confirm the employment and eligibility of all newly hired employees. To learn more about E-Verify, including your rights and responsibilities, please visit *********************
    $24.7-35.7 hourly Auto-Apply 25d ago
  • Engineering Technician II 1st shift

    Cretex 4.0company rating

    Dassel, MN jobs

    Medical Cretex Medical is a leading contract manufacturer of precision components and assemblies for the medical device industry. Our customers view us as a trusted partner in the areas of injection molding, laser processing, metal stamping and device assembly. Learn more at ********************** Position Summary: The Engineering Technician II will work alongside Manufacturing Engineers supporting technical operations in a high-volume medical device contract manufacturing facility. This person is directly responsible for assembling prototypes, executing test protocols, documenting results, evaluating new manufacturing process instructions, and providing feedback to the engineering and manufacturing teams. This position will also assist with developing and maintaining tooling and fixtures. Responsibilities • First point of contact for technical support escalation for operations • Provide assembly process feedback to the engineering team • Responsible to monitor, inspect, setup, calibrate, and maintain manufacturing process equipment • Research and identify manufacturing or engineering solutions • Diagnose and troubleshoot technical issues, including but not limited to, machining, injection molding, laser processing, stamping, or packaging • Assist engineers as they create, modify, and test products and processes • Inspect products and processes for flaws and identify areas of improvement • Conduct tests and collect data in support of validation activities • Utilize and uses computer-aided design and drafting software • Develops production drawings for manufacturing • Reads and complies with work instructions, set up sheets, and checklists • Enters production information into the ERP system on a timely basis • Generate ECO/DCO and process documentation changes related to manufacturing changes, such as work instruction changes, print changes, documentation updates, etc. • Perform equipment set-ups as required • Support and comply with the company Quality System, ISO, and medical device requirements • Read, understand, and follow work instructions and standard work • Partner with other business segments: sales/marketing, customer service, engineering, quality, and finance Qualifications • 3 years of experience working as an engineering technician • Knowledge of Good Manufacturing Practices & Quality Systems Regulations is desirable • Medical product experience • Must have good communication and documentation skills • Must have problem solving and critical thinking skills • Working knowledge of CAD software platforms AutoCAD, SolidWorks, or Pro-E experience is desired. • Ability to cross train in other areas of production when required • Microsoft Office proficiency (Outlook, Word, Excel, PowerPoint, Publisher) • Clear and effective verbal and written communication skills • Attention to detail • Organizational skills • Ability to work in a fast-paced team environment • Ability to prioritize and multitask Desirable Criteria and Qualifications • Associate Degree in Engineering • 3-5 years of engineering experience What is it like to work at Cretex Medical? We recognize the contribution of every individual and promote growth, safety and security for all our employees. Cretex Medical values performance and pays competitive wages along with a rich benefit package. We offer a positive work environment with a focus on continuous improvement. Here are some of things that employees have said about working for Cretex Medical: “The culture at Cretex is collaborative. Everyone here is willing to help you whether it is a director, a machinist, or your boss. Everyone is always willing to help you figure out a project and get it done right.” “I would tell potential interns that Cretex is a great company to work for. It has set a high bar for corporate culture as well as the quality of work you can do. I would definitely recommend it.” “I learned that I really like the medical device industry. The importance and the gravity of what we do here is felt by the employees. You can have that passion in your work because you know what you are striving for is to save lives.” We encourage you to explore the many opportunities Cretex Medical can offer you as a valued team member. Pay Range USD $24.66 - USD $35.72 /Hr. Pay Range Details This pay range reflects the base hourly rate or annual salary for positions within this job grade, based on our market-based pay structures. Actual compensation will depend on factors such as skills, relevant experience, education, internal equity, business needs, and local market conditions. While the full hiring range is shared for transparency, offers are rarely made at the minimum or maximum of the range. Company Benefits All Employees: Our 401k retirement savings plan with a company match contribution; onsite health clinics, discretionary holiday bonus program (based on years of service), Cretex University, 24/7 employee assistance program with access to five confidential visits with a licensed counselor at no cost, wellness program with incentives, an employee death benefit, and employee sick and safe leave are available to all Cretex employees. 20+hours: Cretex's medical benefit package includes: comprehensive medical insurance with access to virtual providers; dental insurance (Little Partners Dental benefit covers services 100 percent for children 12 and younger when seen by a Health Partners in network provider); vision insurance; a pre-tax health savings account, healthcare and dependent care pre-tax reimbursement accounts; paid holidays, paid time off; and our discretionary profit sharing program are available to employees working 20+ hours/week. 30+ hours: Parental Leave, accident and critical illness benefits, optional employee, spouse, and child life; short and long term disability; company provided life insurance; and tuition assistance programs are available to employees working 30+ hours per week. (Some benefits are subject to eligibility criteria.) Applicants will receive consideration for employment regardless of their race, color, creed, religion, national origin, sex, sexual orientation, gender identity, disability, age, veteran status, marital status, family status, status with regard to public assistance, or any other protected status as required by law. Our company uses E-Verify to confirm the employment and eligibility of all newly hired employees. To learn more about E-Verify, including your rights and responsibilities, please visit *********************
    $24.7-35.7 hourly Auto-Apply 17d ago
  • Engineering Technician 1st shift

    Cretex 4.0company rating

    Dassel, MN jobs

    Medical Cretex Medical is a leading contract manufacturer of precision components and assemblies for the medical device industry. Our customers view us as a trusted partner in the areas of injection molding, laser processing, metal stamping and device assembly. Learn more at ********************** Position Summary: The Engineering Technician will work alongside Manufacturing Engineers supporting technical operations in a high-volume medical device contract manufacturing facility. This person is directly responsible for assembling prototypes, executing test protocols, documenting results, evaluating new manufacturing process instructions, and providing feedback to the engineering and manufacturing teams. This position will also assist with developing and maintaining tooling and fixtures. Position is open to Engineering Tech I or Engineering Tech II (based on experience) Responsibilities • First point of contact for technical support escalation for operations • Provide assembly process feedback to the engineering team • Responsible to monitor, inspect, setup, calibrate, and maintain manufacturing process equipment • Research and identify manufacturing or engineering solutions • Diagnose and troubleshoot technical issues, including but not limited to, machining, injection molding, laser processing, stamping, or packaging • Assist engineers as they create, modify, and test products and processes • Inspect products and processes for flaws and identify areas of improvement • Conduct tests and collect data in support of validation activities • Utilize and uses computer-aided design and drafting software • Develops production drawings for manufacturing • Reads and complies with work instructions, set up sheets, and checklists • Enters production information into the ERP system on a timely basis • Generate ECO/DCO and process documentation changes related to manufacturing changes, such as work instruction changes, print changes, documentation updates, etc. • Perform equipment set-ups as required • Support and comply with the company Quality System, ISO, and medical device requirements • Read, understand, and follow work instructions and standard work • Partner with other business segments: sales/marketing, customer service, engineering, quality, and finance Qualifications 3 years of experience working as an engineering technician (Engineering Technician Level II) Prior chemical handling experience strongly preferred Knowledge of Good Manufacturing Practices & Quality Systems Regulations is desirable Medical product experience Must have good communication and documentation skills Must have problem solving and critical thinking skills Working knowledge of CAD software platforms AutoCAD, SolidWorks, or Pro-E experience is desired. Ability to cross train in other areas of production when required Microsoft Office proficiency (Outlook, Word, Excel, PowerPoint, Publisher) Clear and effective verbal and written communication skills Attention to detail Organizational skills Ability to work in a fast-paced team environment Ability to prioritize and multitask Desirable Criteria and Qualifications • Associate Degree in Engineering • 3-5 years of engineering experience What is it like to work at Cretex Medical? We recognize the contribution of every individual and promote growth, safety and security for all our employees. Cretex Medical values performance and pays competitive wages along with a rich benefit package. We offer a positive work environment with a focus on continuous improvement. Here are some of things that employees have said about working for Cretex Medical: “The culture at Cretex is collaborative. Everyone here is willing to help you whether it is a director, a machinist, or your boss. Everyone is always willing to help you figure out a project and get it done right.” “I would tell potential interns that Cretex is a great company to work for. It has set a high bar for corporate culture as well as the quality of work you can do. I would definitely recommend it.” “I learned that I really like the medical device industry. The importance and the gravity of what we do here is felt by the employees. You can have that passion in your work because you know what you are striving for is to save lives.” We encourage you to explore the many opportunities Cretex Medical can offer you as a valued team member. Pay Range USD $22.40 - USD $35.72 /Hr. Pay Range Details This pay range reflects the base hourly rate or annual salary for positions within this job grade, based on our market-based pay structures. Actual compensation will depend on factors such as skills, relevant experience, education, internal equity, business needs, and local market conditions. While the full hiring range is shared for transparency, offers are rarely made at the minimum or maximum of the range. Company Benefits All Employees: Our 401k retirement savings plan with a company match contribution; onsite health clinics, discretionary holiday bonus program (based on years of service), Cretex University, 24/7 employee assistance program with access to five confidential visits with a licensed counselor at no cost, wellness program with incentives, an employee death benefit, and employee sick and safe leave are available to all Cretex employees. 20+hours: Cretex's medical benefit package includes: comprehensive medical insurance with access to virtual providers; dental insurance (Little Partners Dental benefit covers services 100 percent for children 12 and younger when seen by a Health Partners in network provider); vision insurance; a pre-tax health savings account, healthcare and dependent care pre-tax reimbursement accounts; paid holidays, paid time off; and our discretionary profit sharing program are available to employees working 20+ hours/week. 30+ hours: Parental Leave, accident and critical illness benefits, optional employee, spouse, and child life; short and long term disability; company provided life insurance; and tuition assistance programs are available to employees working 30+ hours per week. (Some benefits are subject to eligibility criteria.) Applicants will receive consideration for employment regardless of their race, color, creed, religion, national origin, sex, sexual orientation, gender identity, disability, age, veteran status, marital status, family status, status with regard to public assistance, or any other protected status as required by law. Our company uses E-Verify to confirm the employment and eligibility of all newly hired employees. To learn more about E-Verify, including your rights and responsibilities, please visit *********************
    $22.4-35.7 hourly Auto-Apply 12d ago

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