Quality Assurance Associate jobs at Dr. Reddy's Lab - 35 jobs

Job Title: Quality Assurance Associate Job Type: Full-time About Us: As a developer, manufacturer, and supplier of essential medicines, Hikma Pharmaceuticals USA Inc. and its affiliates' purpose is to put better health within reach, every day for millions of patients around the world. We are a trusted, reliable partner and dependable source of over 760 high-quality generic, specialty and branded pharmaceutical products that hospitals, physicians and pharmacists need to treat their patients across North America, the Middle East, North Africa and Europe. Through our global footprint of 30+ manufacturing plants, 8+ R&D centers, and 9,000+ empowered employees, we are committed to making high-quality medicines accessible to the people who need them. Description: We are committed to building a diverse and inclusive team and encourage applications from candidates of all backgrounds. We are seeking a talented and motivated Quality Assurance Associate. In this role, you will be responsible for performing field QA activities: in process checks in the aseptic processing area, approval for area clearance, AQL inspection for finished products, retention sampling for finished products, batch record review, final product release, review and approve operation documents and forms, and approval / rejection of in-coming raw materials, components, and final product labels. Ensure compliance of operations personnel with the company's procedures and Good Manufacturing Practices (GMPs). This position will also be responsible for identifying any deviations or non-conformances, writing deviation reports, performing root cause analysis, writing/revising standard operating procedures and forms, and tracking metrics, when required. Key Responsibilities: * Regular and predictable onsite attendance and punctuality. * Perform monitoring of Compounding in the aseptic processing area. * Perform AQL inspection for Finished products * Perform in-coming raw material, component, and labeling inspection and release. * Review executed batch records to ensure compliance with approved procedures, and communicate and resolve discrepancies with manufacturing operators and supervisors. * Provide Quality support to Manufacturing personnel on the floor - providing guidance during GMP events and initiation of deviations and investigations. * Lead small scope projects, as assigned. * Prepare and/or revise SOPs to ensure compliance with regulations and current practices. Keep current with regulations and industry best practices and update SOPs to improve compliance. * Prepare all necessary reports in a timely manner to meet compliance requirements and business needs. * Participate in Process Validation activities, including protocol execution and reporting, as necessary. * Working knowledge of FDA regulations and application of GMPs. Qualifications: We value the skills and experiences candidates bring to the table. While we have listed some qualifications below, we encourage candidates to apply even if they do not meet all of them: * Bachelor's degree in relevant science or engineering discipline. * 4+ years of relevant cGMP experience. * Hands-on experience with batch record review and product disposition. * Hands-on experience with ERP, Documentation, and LIMS systems. * Strong written and verbal skills. * Demonstrated effectiveness in task completion, decision making, and problem solving * Excellent writing and computer skills and ability to present data in a logical manner. * Excellent interpersonal and communication skills. * Excellent organization and time management skills. * Ability to work in a high-paced team environment. * Working knowledge of FDA regulations, application of GMPs. Preferred Qualifications: * The qualified candidate must possess a strong background in Quality Assurance, Quality Compliance and Quality Systems. * Experience in a 503B Compounding manufacturing environment. * Experience in FDA/EMA regulations in biopharmaceuticals or sterile injectable manufacturing is preferred. * Work in an aseptic processing environment. * Experience with use of complex research techniques and methodologies like six sigma and Kaizen to improve process/product quality. Compensation: Base Salary: $ 56,950 - $ 85,000 annually. 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: Dayton, NJ, US, 08810 Nearest Major Market: New Jersey

Senior Quality Assurance Expert Princeton, NJ Join our team as a Food Safety & Quality Specialist, ensuring compliance with regulatory and company standards while maintaining key procedures, training, and certifications. You'll lead risk assessments, site tours, and incident investigations, providing practical guidance and driving effective corrective and preventive actions. The role also supports audits, KPI development, continuous improvement initiatives, and cross‑functional projects across the site. Success requires hands‑on engagement during inspections, including extended standing and sample handling. Your key responsibilities * Compliance with Standards & Procedures: Ensure compliance with legislation, DSM-Firmenich policies, and BU requirements. Maintain and update food safety and quality procedures, standards, and training materials. * Risk Assessments & Site Monitoring: Conduct food safety and quality risk assessments (HACCP, TACCP, VACCP). * Lead food safety and quality tours to assess compliance on site. * Practical Support & Issue Resolution: Provide practical advice on food safety and quality issues. Identify non-compliance and recommend corrective actions. * Incident Management & CAPA: Lead investigations into food safety and quality incidents using root cause analysis. * Ensure effective closure of corrective and preventive actions (CAPA). We bring * Unique career paths across health, nutrition and beauty - explore what drives you and get the support to make it happen * A chance to impact millions of consumers every day - sustainability embedded in all we do * A science led company, cutting edge research and creativity everywhere - from biotech breakthroughs to sustainability game-changers, you'll work on what's next * Growth that keeps up with you - you join an industry leader that will develop your expertise and leadership * A culture that lifts you up - with collaborative teams, shared wins, and people who cheer each other on. * A community where your voice matters - it is essential to serve our customers well. You bring * Bachelor's degree in food science, microbiology, biology, chemistry, or related. * 3-5 years' experience in food industry, pharmaceutical chemical industry within a manufacturing background. * Fluency in local language essential, English language fluency essential * Highly self-motivated showing strong self-discipline and a structured approach to practices & improvements * Industry related Professional Qualifications essential, e.g. HACCP,TACCP, Lead Auditor, * Understanding of Food Safety and Quality Management Systems is essential (BRC, FSSC, ISO) The salary or hourly wage scale provided reflects the pay range dsm-firmenich expects to pay the successful candidate for the position. Individual pay offered will be based on the applicant's job-related skills, experience, relevant education, or training, and primary work location. Salary $115,000 - $120,000. In addition to base salary, we also offer a comprehensive total rewards package, inclusive of annual incentive pay, a retirement savings plan, health care coverage, paid time off, recognition programs and a broad range of other benefits. All benefits and incentives are subject to eligibility requirements. About dsm-firmenich At dsm-firmenich, we don't just meet expectations - we go beyond them. Join our global team powered by science, creativity, and a shared purpose: to bring progress to life. From elevating health to making fortified food and sustainable skincare, the impact of your work here will be felt by millions - every single day. Whether it's fragrance that helps you focus, alternative meat that's better for the planet, or reducing sugar without losing flavor, this is where you help shape the future of nutrition, health, and beauty for everyone, everywhere. And while you're making a difference, we'll make sure you're growing too. With learning that never stops, a culture that lifts you up and the freedom to move across businesses, teams, and borders. Your voice matters here. And your ideas? They're essential to our future. Because real progress only happens when we go beyond, together. Inclusion, belonging and equal opportunity statement At dsm-firmenich, we believe being a force for good starts with the way we treat each other. When people feel supported, included, and free to be themselves, they do their best work - and that's exactly the kind of culture we're building. A place where opportunity is truly equal, authenticity is celebrated, and everyone has the chance to grow, contribute, and feel they belong. We're proud to be an equal opportunity employer, and we're serious about making our hiring process as fair and inclusive as possible. From inclusive language and diverse interview panels to thoughtful sourcing, we're committed to reflecting the world we serve. We welcome candidates from all backgrounds - no matter your gender, ethnicity, sexual orientation, or anything else that makes you, you. And if you have a disability or need any support through the application process, we're here to help - just let us know what you need, and we'll do everything we can to make it work. Agency statement We're managing this search directly at dsm-firmenich. If you're applying as an individual, we'd love to hear from you. We're not accepting agency submissions or proposals involving fees or commissions for this role.

**Job Purpose** + The Specialist Quality Assurance is responsible for providing support to the Quality Assurance department. + This role will work with cross-functional teams to maintain internal Quality Systems. + Key Roles and Responsibilities + Assist in the execution of Quality Systems to support GLP, GMP and GCP, including both internal and external work + Support internal GxP activities + Administer, follow-up, write, review and approve Quality System documentation (deviations, investigations, CAPA) + Review and help approve all GxP documentation including master batch records, labels, protocols, forms, stability data and reports + Assist with tracking and trending of Quality System metrics (deviations, investigations, CAPA, etc.) + Write, review and approve SOPs and Forms + Help to maintain equipment related to GMP testing and manufacturing + Help maintain Qualitys Supplier Qualification Program + Help maintain other GxP programs as needed + Assist with internal and external audits as needed **Qualification, Skill and Competencies Requirements** + BA/BS in Life Sciences + Minimum of 2 years GxP experience + Strong knowledge of MS Word and Excel + Excellent written and verbal communication skills + Must be able to work both independently and in a team situation The presently-anticipated base compensation pay range for this position is $95,500 to $106,000. 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. 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. 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.

"Expect to grow", personally and professionally: At Siegfried, we offer exciting challenges and ample opportunities to showcase your talents. As a trusted and respected partner to the pharmaceutical industry, we uphold the highest standards in safety, quality and sustainability, while fostering a culture that empowers you to thrive. Join a rapidly expanding global company, where diverse perspectives and experiences come together in a collaborative environment. Here, you'll find a workplace that values both collective success and your individual contributions-offering long-term opportunities to grow and make an impact. Your Role: SUMMARY: The incumbent assures compliance to all regulatory requirements, current Good Manufacturing Practices, and company Policies, Standard Operating Procedures and Work Instructions. ESSENTIAL DUTIES, RESPONSIBILITIES AND ACCOUNTABILITIES: • Reviews, approve and tracks executed production records. • Reviews and approves production investigations. • Reviews lab sample results and manufacturing records relative to qualification/validation activities. • Reviews and approves Master Production Records. • Responsible for cGMP compliance of assigned manufacturing operations / areas. • Completes pre-campaign action items as assigned. • Is responsible for the conditional / final release of materials. • Reviews finished product labels. • Reviews and approves COAs. • Prepares and reviews product trees. • Writes Process Qualification Documents • Assists with GMP inspections • Conducts environmental monitoring • Maintains QA databases for products / equipment as appropriate. • Adheres to personal moral, ethical, legal, and behavioral conduct that is in compliance with the Siegfried Code of Conduct. • Adheres to all applicable SHE and CGMP regulations. Your Profile: EDUCATION AND EXPERIENCE: A BA/BS degree in microbiology, biology, or chemistry, or 2-3 years of experience in batch record review in a pharmaceutical manufacturing environment required, or an equivalent combination of education and experience. Thorough knowledge of cGMP is required. OTHER REQUIREMENTS: Must have excellent communication skills. Must be conscientious and detail-oriented. Must have excellent computer skills (MS Office, WinLIMS, SAP). Must be a team player. Must be able to self-manage daily work and set priorities. Must be able to manage projects and prioritize appropriately. Siegfried USA will explore and provide reasonable accommodations to assist any qualified individual with a disability in performing the essential functions of his/her job. Please speak with HR should you require an accommodation or have any questions. Siegfried USA will explore and provide reasonable accommodations to assist any qualified individual with a disability in performing the essential functions of his/her job. Please speak with HR should you require an accommodation or have any questions. Your Benefits: Paid Time Off, Health Insurance, Retirement Planning Founded in 1873 in Zofingen, Switzerland, Siegfried has grown into a global network of 13 sites across three continents. With a team of more than 3,800 highly skilled professionals, we take the innovations of our pharmaceutical customers to industrial scale and manufacture safe drugs for patients worldwide. As a fully integrated CDMO, Siegfried is one of the few organizations today that can carry out the development and manufacturing of APIs and finished dosage forms under one roof. This unique combination of know-how and experience makes us the most trusted partner in the pharmaceutical industry.

A brief on the JD is as follows: * Knowledge of CI/CD * Should now how to work in Agile, Jenkins, Puppet, Chef, Jira, Bitbucket and Ansible environments * Should have good understanding of CSV (Computer System Validation) * Knowledge of GMP/GXPs * Knowledgeable of ER and ES (Electronic records and Electronic Signatures) technologies * Versed with CFR 21 Part 11 (Code for Federal Regulations) * Approx. 3 years of experience * Preferably local in NJ/NY area

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 Assist in performance of all Quality Assurance functions as outlined in the GLPs and PSL SOPs. Assist the Quality Assurance Director as needed during inspections by EPA, FDA or clients. Prepare records and assemble copies of documents requested by inspectors when advance notice is given and Sponsor and/or Laboratory Director approval is obtained. Conduct in-process study inspections and general facility inspections in the toxicology and chemistry laboratories as directed. Audit raw data and proofread report and tables against raw data for accuracy and for typing corrections. Audit final report to verify corrections. Amend and update Standard Operating Procedures as required using word processing system. File all QAU-related paperwork as directed. Select intervals for inspection for any regulatory test under the auditor's responsibility or as directed by QA Director, Laboratory Director, or President. Perform such inspections in accordance with the test schedule. When the time for conduct of intervals requiring inspection falls outside of normal working hours, this will be brought to the attention of the Study Director or QA Director in order that a suitable arrangement may be made. Ability to safely wear a respirator required. Other duties as assigned. Qualifications QA auditors will have experience in a laboratory regulated by FDA/EPA GLP standards. Experience in other quality standards such as cGMP or GCP will also be considered. Experience with acute toxicology, analytical chemistry, and/or general laboratory procedures is preferred. B.S. degree in biology, toxicology, animal science or related field and/or AALAS certification at the Technician level is also preferred. Experience in computer system validation and electronic data capture is desirable but is not required. The individual holding this position must be of the highest integrity and have a very strong sense of responsibility. Attention to detail is essential. He/she must be well organized, tactful, be able to work independently and maintain all records, documents, and schedules associated with quality assurance procedures and studies. Communication skills, especially written, are necessary. Proficiency with MSWord and Excel is required. He/she must have a current tetanus vaccination if required to access the vivarium. Additional Information Position is full-time, Monday-Friday 8am-5pm. Candidates within a commutable distance of South Brunswick, NJ are encouraged to apply. Compensation: $22.50-$25.50/hr Excellent full-time benefits including: Comprehensive medical coverage, dental, and vision options. Life and disability insurance 401(k) with company match Paid vacation and holidays Eurofins USA BioPharma Services is a Disabled and Veteran Equal Employment Opportunity employer.

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 Assist in performance of all Quality Assurance functions as outlined in the GLPs and PSL SOPs. Assist the Quality Assurance Director as needed during inspections by EPA, FDA or clients. Prepare records and assemble copies of documents requested by inspectors when advance notice is given and Sponsor and/or Laboratory Director approval is obtained. Conduct in-process study inspections and general facility inspections in the toxicology and chemistry laboratories as directed. Audit raw data and proofread report and tables against raw data for accuracy and for typing corrections. Audit final report to verify corrections. Amend and update Standard Operating Procedures as required using word processing system. File all QAU-related paperwork as directed. Select intervals for inspection for any regulatory test under the auditor's responsibility or as directed by QA Director, Laboratory Director, or President. Perform such inspections in accordance with the test schedule. When the time for conduct of intervals requiring inspection falls outside of normal working hours, this will be brought to the attention of the Study Director or QA Director in order that a suitable arrangement may be made. Ability to safely wear a respirator required. Other duties as assigned. Qualifications QA auditors will have experience in a laboratory regulated by FDA/EPA GLP standards. Experience in other quality standards such as cGMP or GCP will also be considered. Experience with acute toxicology, analytical chemistry, and/or general laboratory procedures is preferred. B.S. degree in biology, toxicology, animal science or related field and/or AALAS certification at the Technician level is also preferred. Experience in computer system validation and electronic data capture is desirable but is not required. The individual holding this position must be of the highest integrity and have a very strong sense of responsibility. Attention to detail is essential. He/she must be well organized, tactful, be able to work independently and maintain all records, documents, and schedules associated with quality assurance procedures and studies. Communication skills, especially written, are necessary. Proficiency with MSWord and Excel is required. He/she must have a current tetanus vaccination if required to access the vivarium. Additional Information Position is full-time, Monday-Friday 8am-5pm. Candidates within a commutable distance of South Brunswick, NJ are encouraged to apply. Compensation: $22.50-$25.50/hr Excellent full-time benefits including: Comprehensive medical coverage, dental, and vision options. Life and disability insurance 401(k) with company match Paid vacation and holidays Eurofins USA BioPharma Services is a Disabled and Veteran Equal Employment Opportunity employer.

South Brunswick Township, NJ, USA Full-time ** 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** + Assist in performance of all Quality Assurance functions as outlined in the GLPs and PSL SOPs. Assist the Quality Assurance Director as needed during inspections by EPA, FDA or clients. Prepare records and assemble copies of documents requested by inspectors when advance notice is given and Sponsor and/or Laboratory Director approval is obtained. + Conduct in-process study inspections and general facility inspections in the toxicology and chemistry laboratories as directed. + Audit raw data and proofread report and tables against raw data for accuracy and for typing corrections. Audit final report to verify corrections. + Amend and update Standard Operating Procedures as required using word processing system. File all QAU-related paperwork as directed. + Select intervals for inspection for any regulatory test under the auditor's responsibility or as directed by QA Director, Laboratory Director, or President. Perform such inspections in accordance with the test schedule. When the time for conduct of intervals requiring inspection falls outside of normal working hours, this will be brought to the attention of the Study Director or QA Director in order that a suitable arrangement may be made. + Ability to safely wear a respirator required. + Other duties as assigned. **Qualifications** + QA auditors will have experience in a laboratory regulated by FDA/EPA GLP standards. Experience in other quality standards such as cGMP or GCP will also be considered. + Experience with acute toxicology, analytical chemistry, and/or general laboratory procedures is preferred. B.S. degree in biology, toxicology, animal science or related field and/or AALAS certification at the Technician level is also preferred. Experience in computer system validation and electronic data capture is desirable but is not required. + The individual holding this position must be of the highest integrity and have a very strong sense of responsibility. Attention to detail is essential. He/she must be well organized, tactful, be able to work independently and maintain all records, documents, and schedules associated with quality assurance procedures and studies. Communication skills, especially written, are necessary. Proficiency with MSWord and Excel is required. He/she must have a current tetanus vaccination if required to access the vivarium. **Additional Information** Position is full-time, Monday-Friday 8am-5pm. Candidates within a commutable distance of South Brunswick, NJ are encouraged to apply. Compensation: $22.50-$25.50/hr Excellent full-time benefits including: + Comprehensive medical coverage, dental, and vision options. + Life and disability insurance + 401(k) with company match + Paid vacation and holidays **Eurofins USA BioPharma Services is a Disabled and Veteran Equal Employment Opportunity employer.**

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 * Assist in performance of all Quality Assurance functions as outlined in the GLPs and PSL SOPs. Assist the Quality Assurance Director as needed during inspections by EPA, FDA or clients. Prepare records and assemble copies of documents requested by inspectors when advance notice is given and Sponsor and/or Laboratory Director approval is obtained. * Conduct in-process study inspections and general facility inspections in the toxicology and chemistry laboratories as directed. * Audit raw data and proofread report and tables against raw data for accuracy and for typing corrections. Audit final report to verify corrections. * Amend and update Standard Operating Procedures as required using word processing system. File all QAU-related paperwork as directed. * Select intervals for inspection for any regulatory test under the auditor's responsibility or as directed by QA Director, Laboratory Director, or President. Perform such inspections in accordance with the test schedule. When the time for conduct of intervals requiring inspection falls outside of normal working hours, this will be brought to the attention of the Study Director or QA Director in order that a suitable arrangement may be made. * Ability to safely wear a respirator required. * Other duties as assigned. Qualifications * QA auditors will have experience in a laboratory regulated by FDA/EPA GLP standards. Experience in other quality standards such as cGMP or GCP will also be considered. * Experience with acute toxicology, analytical chemistry, and/or general laboratory procedures is preferred. B.S. degree in biology, toxicology, animal science or related field and/or AALAS certification at the Technician level is also preferred. Experience in computer system validation and electronic data capture is desirable but is not required. * The individual holding this position must be of the highest integrity and have a very strong sense of responsibility. Attention to detail is essential. He/she must be well organized, tactful, be able to work independently and maintain all records, documents, and schedules associated with quality assurance procedures and studies. Communication skills, especially written, are necessary. Proficiency with MSWord and Excel is required. He/she must have a current tetanus vaccination if required to access the vivarium. Additional Information Position is full-time, Monday-Friday 8am-5pm. Candidates within a commutable distance of South Brunswick, NJ are encouraged to apply. Compensation: $22.50-$25.50/hr Excellent full-time benefits including: * Comprehensive medical coverage, dental, and vision options. * Life and disability insurance * 401(k) with company match * Paid vacation and holidays Eurofins USA BioPharma Services is a Disabled and Veteran Equal Employment Opportunity employer.

Our Supervisor, Quality Assurance 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 supervising all Quality Assurance (QA) aspects of compounding pharmaceuticals for compliance within the facility. This position operates within the legal and regulatory compliance, producing a quality product. Turn your passion for precision and your commitment to quality into a meaningful impact on healthcare across the US. What the Supervisor, Quality Assurance Does Each Day: * Supervises Quality Assurance staff on assigned shift * Oversees failure and discrepancy investigations and documenting investigations on process deviations or equipment malfunctions * Develops and provides oversight to identification and implementation of appropriate corrective actions and preventive actions * Oversight of the environmental monitoring program including appropriate escalation of environmental and personnel monitoring results that exceed alert or action limits and interpreting results. * Responsible for timely and accurate disposition of finished product to assure each batch meets specification prior to release * Periodically review records to verify that quality standards for each drug product is met * Maintain compliance with FDA 503B and cGMP guidelines / state and federal laws * Responsible for maintaining QA records associated with internal and external testing * Responsible to maintain all testing equipment in compliance, calibration, and certification * Assists in developing policies and procedures related to QA * Promptly communicates with Operations regarding complaints, product issues/variance * Assists in maintaining compliant controlled substance documentation specifically associated with sample handling and reconciliation * Enforces applicable personnel policies and procedures Our Most Successful Supervisor, Quality Assurance: * 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 * 1 year of supervisory or management experience required * 2 years' experience in Quality Assurance / cGMP / FDA regulated industry * 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 other related field 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 * 22 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 * The base compensation for this role is estimated to be within the range described below. The compensation offered may vary depending on relevant factors such as experience, skills, training, education, certifications, geographic location, and market conditions * Range: $74,766 - $102,812 / Hour or Year About Quva: Quva provides industry-leading health-system pharmacy services and solutions, including 503B sterile injectable outsourcing services and AI-based data software solutions that help power the business of pharmacy. Quva Pharma's multiple production facilities and industry-first dedicated remote distribution capabilities provide ready-to-administer sterile injectable medicines critical to patient care. Quva BrightStream partners with health systems to aggregate, normalize, and analyze large amounts of complex data across their sites of care, and through proprietary machine learning, transforms data into actionable insights supporting revenue optimization, script capture, inventory management, drug shortage control, and more. Quva's overall progressive and integrated platform helps health-systems transform pharmacy management to achieve greater value and deliver 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." California Consumer Privacy Act (CCPA) Notice for Applicants and Employees

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:** Under limited supervision, manages laboratory compliance activities for assigned functions and projects. Investigates method performance, reliability and improvement issues, and evaluates proposed changes to compendial or in-house methods. Prepare and review the technical and compliance documents such as analytical methods, specifications, Method Validation/Transfer Protocols and Reports, SOPs accordingly to companys standards and FDA /ICH guidelines, CAPAs, Lab Event/Out-of-Specification and Out-of-Trend investigations. To review the USP and other compendia changes on a timely basis and update the related documents to implement the changes and ensure the compliance. **Area Of Responsibility:** + Writes technical documents such as methods, specifications, method validation protocols and reports, method transfer protocols and reports based on corporate policies and SOP's, compendial, ICH and FDA regulatory guidance. + Ensures that the integrity and accuracy of all laboratory documents are maintained; must assess overall document compliance with protocols, SOPs, company policies, and applicable regulations. + Evaluates compendial documents, and reviews procedures for laboratory compliance. + Evaluate Sun global documents (GQS and GSOP) against site specific procedures and update the site procedure accordingly. + Reviews analytical data for accuracy, completeness and compliance to cGMPs and established laboratory documentation standards. + Generates change requests required for analytical documents, and routes documents for review and approval. Maintains hard copies and electronic file of technical documents. + Timely provide the QC documents required for CBE, PAS and ANDA submission to RA. + Collaborates with colleagues and external partners to achieve individual and department goals. + Ensure compliance with cGMPs, DEA regulations and site operating procedures under the direction of QC Management. + Ensure Lab Event/Out-of-Specification and Out-of-Trend investigations are properly conducted and closed on a timely fashion. + Ensure continuous laboratory compliance by adopting best industry practice and complying with procedure requirements. **Work Conditions:** Manufacturing/Production environment Environmental related to manufacturing/production environments: + Noise: Sufficient noise, either constant or intermittent, to cause marked distraction or possible injury to sense of hearing. + Fumes: Smoky or vaporous emissions, usually odorous, thrown off as the result of combustion or chemical reaction. + Odors: Unpleasant smells. + Gases: Examples include carbon monoxide and ozone. + Dust: Airborne particles of any kind, such as textile dust, wood, and silica. Hazards: Conditions where there is danger to life, health or bodily injury such as closeness to moving mechanical parts; working on scaffolding and high places; exposure to burns, radiant energy, explosives, toxic chemicals, and electric shock. **Physical Requirements:** + Stand, sit, walk, use hands and fingers to handle or feel, reach with arms and hands, talk or hear, stoop, kneel, crouch or crawl. + Close vision; depth perception; ability to adjust focus + Use of repetitive motion + Able to operate computer/office machines + Able to lift and carry up to 50 lbs. **Travel Estimate:** Up to 5% **Education and Job Qualification:** + Minimum BS or equivalent degree in Chemistry or related discipline. + Good computer skills, and competence with Microsoft Office (Word, Excel, PowerPoint) and Access. + Must have an understanding of FDA guidelines, ICH guidance and DEA regulations. Ensures compliance with cGMPs, DEA regulations, safety and site operating procedures under the direction of Management. + Must have LIMS and SAP knowledge. + Must be familiar with proper cGMP practices for analytical laboratories and working knowledge of basic laboratory instrumental analysis and wet chemistry skills. + Must have cGMP compliance knowledge and experience. + Collaborates with colleagues and external partners to achieve primary Department goals. + Works in coordination with project plans and goals as assigned by Management. + Demonstrated strong communication: verbal, written and presentation skills. + A self-starter with a hands-on approach and a can-do attitude. + Excellent project management and problem solving skills. + The requirement for English language proficiency for this job role is Intermediate-B1+ (comparable to Global CEFR Independent B1) level based on the Common European Framework of Reference for Languages (CEFR). **Experience:** + Minimum of four (3) years of experience in the pharmaceutical industry preferred. **_Disclaimer:_** _The preceding has been designed to indicate the general nature and level of work performed by employee 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 incumbent(s)._ _The presently-anticipated base compensation pay range for this position is $75,500 to $83,000. 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.

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 2nd shift, working Monday through Friday from 3:00 PM to 11:00 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. 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 The base compensation for this role is estimated to be within the range described below. The compensation offered may vary depend on on relevant factors such as experience, skills, training, education, certifications, geographic location, and market conditions Salary Range: $16.50 - $23.98 + $2.50 shift differential for 2nd shift 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.” California Consumer Privacy Act (CCPA) Notice for Applicants and Employees

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 2nd shift, working Monday through Friday from 3:00 PM to 11:00 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. 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 * The base compensation for this role is estimated to be within the range described below. The compensation offered may vary depend on on relevant factors such as experience, skills, training, education, certifications, geographic location, and market conditions * Salary Range: $16.50 - $23.98 + $2.50 shift differential for 2nd shift 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." California Consumer Privacy Act (CCPA) Notice for Applicants and Employees

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

Scientist, Quality Control Solaris Pharma Corporation is a leading specialty pharmaceutical company committed to identifying, developing and marketing of high-quality, complex, generic and specialty pharmaceutical products. With a thorough knowledge of the development life cycle and well-trained, committed scientific personnel, Solaris Pharma Corporation has streamlined processes that are efficient in reducing development costs and shortening timelines, without compromise in quality. We are dedicated to developing a broad portfolio of generic and specialty pharmaceutical products and providing early access to complex generic products for patients. Our pipeline which encompasses products from multiple dosage forms include but are not limited to sterile, dermatological, tablet products among others which are challenging to develop and manufacture with complexities arising from formulation & process development, regulatory hurdles, stability and scale up. Solaris Pharma Corporation is currently developing several topical, sterile and tablet products, which are in different stages of development. The company has a dedicated team of committed and well-trained scientists along with experienced program managers and regulatory personnel who provide a robust product development process. The entire end-to-end product development process has been validated through multiple product approvals. A robust commercial infrastructure is in place to market our approved products. The commercial team has reinforced our success with timely product approvals by successfully launching multiple products under the Solaris label onto the market. Solaris has established an excellent reputation for being a dependable supplier with greater than 99% approval rating. The dosage forms that are being developed at our facility include: Topicals, Solutions, Suspensions, Ophthalmic and other sterile products and Tablets. Description: Solaris Pharma Corporation is seeking a Scientist, Quality Control with 3-5 years' experience within the pharmaceutical industry. Responsibilities: Performs chemical analysis of raw materials, in-process and finished pharmaceutical products, including products on stability, according to written methods or compendial methods as applicable, material specifications, using analytical techniques such as IR spectroscopy, UV-Vis spectroscopy, viscosity, particle size or droplet size by laser diffraction, melting point by DSC, water content by TGA/ Karl Fischer, IR, TLC, pH meter, identification by XRPD, and chromatographic techniques, adhering to company policies as identified in standard operating procedures (SOPs). Must be able to follow compendial (USP/EP/BP/JP) procedures/ in-house (SOPs) with limited supervision. Comply with cGMPs, SOPs, and STPs to avoid an out-of-specification situation. Assure compliance with state and federal regulations. Prepares samples for analysis involving thorough cleanliness and complex steps for analysis using chromatographic techniques and analysis. Creates and maintains laboratory record documentation (notebooks and computer-based), documents exact steps followed during analysis execution, calculates and reports results in a timely manner. Actively participate in any project work as and when assigned. Perform process validation and cleaning validation/verification testing on various drugs. Assist other scientists with analytical, instrument and software related problems as required. Review laboratory analysis data for completeness, specification compliance, with company's written policies. Actively participates in and leads any abnormal findings/ investigation of out-of-specification laboratory results with Supervisor. As assigned, perform in-depth review of analytical records/reports to assure that calculations and other data are technically correct and compliant to relevant specifications. Responsible for executing analytical method validation // method transfer activities. Ensures that expired chemicals and reference standards are removed from the laboratory area, perform calibration of dissolution apparatus, FT-IR, UV-Vis spectrophotometer, HPLC, GC, and other laboratory instruments assigned by the supervisor. Experience: Familiarity with GLP/GMP guidelines. Familiarity with out-of-specification (OOS) and out-of-trend (OOT) investigation. Computer literate. Requirements: Bachelor's degree in chemistry, Biology, Materials Science. Ability to meet attendance standards. All full-time employees are required to work a 40-hr week. At times it may be necessary to work additional hours to get the required tasks accomplished to meet deadlines. Must be detail oriented. Demonstrate ability to explain complex concepts with clarity and simplicity Assists, as and when needed, senior scientists working in the laboratory.

This role is responsible for monitoring and ensuring that all incoming raw materials, packaging components, and returned goods are properly sampled, inspected, and tested, as applicable, to confirm compliance with established specifications. To monitor and ensure all phases of drug manufacturing are in compliance with established specifications. To receive, inspect, release and control of labels and outserts. To ensure quality compliance before, during and after each packaging run. Essential Functions: Perform inspection, sampling, and testing (where applicable) on all incoming raw materials, packaging components, and returned goods following detailed written procedures. Prepare samples for chemical and microbiological analysis (where required) and deliver them to the QC lab. Inspect and test packaging components using various measuring devices such as scales, micrometers, and height gauges to determine conformance to specifications. Maintain detailed records of sampling, inspections, and testing activities. Assign and verify expiry dates and retest dates for all GMP raw materials through vendor COA and in-house COA. Collect packaged product samples for annual stability. Perform room, equipment, and packaging line checks (where applicable) prior to each stage of manufacturing following detailed written procedures. Conduct in-process testing per manufacturing and packaging batch record instructions. Prepare controlled/uncontrolled/packaged finished product samples for QC lab and QA retains, following detailed documentation procedures. Maintain standard weights required to perform daily verification of balances. Handle labeling component receipt, visual examination, counting, preliminary inspection, and sampling. Prepare labeling components/outserts inspection reports; quarantine and release labels; maintain incoming components log and corresponding inventory cards. Issue labeling components/outserts according to packaging order and regularly monitor and audit the label room. Complete QA final labeled product inspection report and final line clearance, including labeling and packaging reconciliation paperwork. Ensure compliance of warehouse areas in terms of isolation of Quarantine, Released, In-Process, Finished Product, Packaged Product, Returned Goods, and Rejected areas. Ensure proper isolation of rejected material generated during batch process and accountability in the batch record. Monitor facility and product environmental operating conditions. Review engineering records (temperature and humidity data, calibration and PM records, pest control records, and contractor-related functions). Review online batch records for completeness of signatures, entries, and reconciliation/yields prior to initiation of the next processing step. Verify functionality of all equipment and associated controls during the batch run. Maintain retention sample room and monitor temperature and humidity; replace chart records as per schedule; review logs and disposition of samples. Additional Responsibilities: Disposition of rejected material and returned drug products as per SOP Performs environmental monitoring in accordance with established schedule (where applicable) Perform applicable testing and prepare report for customer complaints Other duties that management may assign. Education: High School or GED - Required Experience: Must have 2 years or more experience in QA or related field Skills: High energy level and organizational skills. - Advanced A certain degree of creativity and latitude - Advanced Basic computer skills (Word and Excel) - Intermediate Specialized Knowledge: Good basic math knowledge and excellent attention to details. Records observations for improving processes. The hourly rate for this position ranges from $20.00-$27.00 per hour. In addition, Amneal offers a short-term incentive opportunity, such as a bonus or performance-based award, as well as a long-term incentive award, such as restricted stock units, with this position within the first 12 months. Amneal ranges reflect the Company's good faith estimate of what Amneal reasonably believes that it will pay for said position at the time of the posting. Individual compensation will ultimately be determined based on a variety of relevant factors, including but not limited to, qualifications, experience, geographic location and other relevant skills. At the heart of our Total Rewards commitment is a comprehensive, flexible and competitive benefits program for eligible positions that enables you to choose the plans and coverage that meet your personal needs. This includes above-market, diverse and robust health and insurance benefits to meet the varied needs of our employees as well as a significant 401(k) matching contribution to help our employees save for retirement. We also promote employee well-being with programs that help you enjoy your career alongside life's many other commitments and opportunities.

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 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 perfomr 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 Additional Responsibilities: * Operate, maintain and calibrate Hardness tester, Friabilitor, 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.

This role is responsible for monitoring and ensuring that all incoming raw materials, packaging components, and returned goods are properly sampled, inspected, and tested, as applicable, to confirm compliance with established specifications. To monitor and ensure all phases of drug manufacturing are in compliance with established specifications. To receive, inspect, release and control of labels and outserts. To ensure quality compliance before, during and after each packaging run. Essential Functions: * Perform inspection, sampling, and testing (where applicable) on all incoming raw materials, packaging components, and returned goods following detailed written procedures. * Prepare samples for chemical and microbiological analysis (where required) and deliver them to the QC lab. * Inspect and test packaging components using various measuring devices such as scales, micrometers, and height gauges to determine conformance to specifications. * Maintain detailed records of sampling, inspections, and testing activities. * Assign and verify expiry dates and retest dates for all GMP raw materials through vendor COA and in-house COA. * Collect packaged product samples for annual stability. * Perform room, equipment, and packaging line checks (where applicable) prior to each stage of manufacturing following detailed written procedures. * Conduct in-process testing per manufacturing and packaging batch record instructions. * Prepare controlled/uncontrolled/packaged finished product samples for QC lab and QA retains, following detailed documentation procedures. * Maintain standard weights required to perform daily verification of balances. * Handle labeling component receipt, visual examination, counting, preliminary inspection, and sampling. * Prepare labeling components/outserts inspection reports; quarantine and release labels; maintain incoming components log and corresponding inventory cards. * Issue labeling components/outserts according to packaging order and regularly monitor and audit the label room. * Complete QA final labeled product inspection report and final line clearance, including labeling and packaging reconciliation paperwork. * Ensure compliance of warehouse areas in terms of isolation of Quarantine, Released, In-Process, Finished Product, Packaged Product, Returned Goods, and Rejected areas. * Ensure proper isolation of rejected material generated during batch process and accountability in the batch record. * Monitor facility and product environmental operating conditions. * Review engineering records (temperature and humidity data, calibration and PM records, pest control records, and contractor-related functions). * Review online batch records for completeness of signatures, entries, and reconciliation/yields prior to initiation of the next processing step. * Verify functionality of all equipment and associated controls during the batch run. * Maintain retention sample room and monitor temperature and humidity; replace chart records as per schedule; review logs and disposition of samples. Additional Responsibilities: * Disposition of rejected material and returned drug products as per SOP * Performs environmental monitoring in accordance with established schedule (where applicable) * Perform applicable testing and prepare report for customer complaints * Other duties that management may assign.

Lantheus (NASDAQ: LNTH) is the leading radiopharmaceutical-focused company, delivering life-changing science to enable clinicians to Find, Fight and Follow disease to deliver better patient outcomes. Headquartered in Massachusetts with offices in New Jersey, Canada, Germany, Sweden, Switzerland and United Kingdom, Lantheus has been providing radiopharmaceutical solutions for nearly 70 years. Today, we're expanding our portfolio and pipeline across oncology, neurology and cardiology. Through recent acquisitions, along with strategic partnerships across the life sciences ecosystem, we are accelerating our efforts to advance precision medicine and improve patient outcomes around the world. At Lantheus we are purpose-driven, and every employee plays a vital role in our success. We're dedicated to cultivating a high-growth, forward-thinking culture where innovation thrives and diverse perspectives drive meaningful progress. Join us and be part of a company where your contributions make a real impact, because we know someone's health is in our hands. Summary of role Senior Quality leader to serve as the Quality lead for the Springfield, NJ Quality organization and internal Quality Operations organizations in Billerica and Springfield. The role will partner closely with the VP, Evergreen Site Operations and serve as a strategic leader for Global Quality as a member of the Quality Leadership team. This position is based in Springfield, NJ and requires a presence on-site of three days per week. It is open to applicants authorized to work for any employer within the United States. Responsibilities * Senior Quality leader to serve as the Quality lead for the Springfield, NJ Quality organization and internal Quality Ops organizations in Billerica and Springfield. The role will partner closely with the VP, Evergreen Site Operations and serve as a strategic leader for Global Quality as a member of the Quality Leadership team. * Lead multiple direct reports from the Springfield, NJ and Billerica Quality Assurance, Quality Control and Compliance teams including the Billerica Quality Site Head and Springfield Quality Assurance, Quality Control and Compliance Leads. Provide strategic counsel to senior leadership on quality-related initiatives, regulatory developments, and business strategy. * Accountable for meeting Quality and budget goals across a complex product portfolio spanning from early-stage development support, clinical stage through to full commercially approved products. Maintaining staffing requirements, mentoring and developing staff, delivering operational and continuous improvement relative to Quality Assurance, Quality Control, Compliance and cost. * Foster a culture of accountability, compliance, and continuous improvement, ensuring adherence to GMPs and internal standards. Lead cross-functional collaboration with departments such as Manufacturing, R&D, HR, Finance and Supply Chain to embed quality into all operations. * Direct and mentor high-performing Quality teams across operational sites. Oversee key performance metrics (KPIs). Ensure compliance with global regulatory standards (e.g., FDA, ISO) and customer requirements. * Champion quality improvement initiatives, analyze quality data to identify trends and drive operational excellence. Make critical decisions on product quality and escalate significant risks to executive leadership. * Review and approve quality-critical documentation, including protocols, reports, and batch records. Provide technical leadership for deviations, CAPAs, change controls, and OOS investigations, ensuring strategic alignment and resolution of major quality events. Basic Qualifications * Bachelor's degree in a related medical, science or business discipline and minimum 20 years' functional experience in Quality or comparable discipline within the pharmaceutical, biopharmaceutical, medical device, or equivalent industries. * 12+ years of management experience. * Demonstrated cross functional leadership skills, with ability to lead and develop teams. Other Requirements * Strong leadership capabilities; builds and develops high performing team. * Excellent verbal, written and presentation skills at all levels both internally and externally, including regulatory bodies as well as customers. * Must be detail oriented with the ability to multitask and respond to ever changing priorities. * Ability to work independently, influence with or without authority, facilitate groups with diverse perspectives and bring teams to consensus/alignment. Core Values The ideal candidate will embody Lantheus core values: * Let people be their best * Respect one another and act as one * Learn, adapt, and win * Know someone's health is in our hands * Own the solution and make it happen The pay range for this position is between $206,000 and $381,000 annually. Actual base pay offered may vary depending on a number of factors such as job-related knowledge, skills and experience. Employees in this position are eligible for a discretionary performance-based cash incentive, and depending on the level of the role may be eligible for a discretionary annual equity award. Benefits for this position include a comprehensive health benefits package that includes medical, prescription drug, dental, and vision coverage. Other offerings include life and disability benefits, pre-tax accounts, a 401(k) with company contribution, and a variety of other benefits. In addition, employees are eligible for a generous time off package including paid vacation, holidays, sick days, and paid parental leave. Interested candidates can apply at Lantheus.com. Applications for this position will be accepted until March 2, 2026. Lantheus is an equal opportunity employer that provides a workplace free from discrimination. All qualified applicants and employees are considered without regard to race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any other characteristic protected by law. Lantheus is an E-Verify Employer. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the Lantheus Talent Acquisition team at ******************************.