Packaging Operator II
Amneal Pharmaceuticals job in Brookhaven, NY
The Packaging Operator II is responsible for safely operating the packaging equipment to package in process products in accordance with the Packaging Order while following SOPs and Maintaining 100% cGMP & compliance during operations.
Essential Functions:
Checks and verifies product/outserts/label as per product specification in the batch record, work order and packaging records.
Checks proper setting and operation of all the packaging equipment located in the packaging rooms.
Responsible for ensuring the packaging line/room is clean, organized and ready for packaging operations.
Performs packaging batch record documentation.
Perform in-process checks during packaging operation and record the data in packaging batch record.
Checks calibration status of all scales, balance and equipment.
Responsible for disposal of rejected products and packaging components in the designated area.
Additional Responsibilities:
Performs other functions as required or assigned
Complies with all company policies and standards.
May monitor equipment performance.
Education:
High School or GED General HS Curriculum/GED - Preferred
-
Experience:
2 years or more in With HS/GED -Experience in Pharmaceuticals Packaging/ Manufacturing
3 years or more in Less than HS/GED- proven related experience in Pharmaceuticals Manufacturing environment.
Skills:
Required to read, write, and communicate in English. - Intermediate
High school level math and mechanical skills. - Intermediate
Flexible to work extended hours and weekends when required. - Intermediate
Ability to work as part of a team. - Intermediate
Attention to detail and accuracy. - Intermediate
Specialized Knowledge:
Knowledge of safety, cGMP and SOP
Additional Requirement: This position requires successful completion of an OSHA-compliant Respirator Fit Test.
The hourly base salary for this position ranges from $18.50 to $20.00 per hour. Amneal ranges reflect the Company's good faith estimate of base salary that 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, 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 helps you enjoy your career alongside life's many other commitments and opportunities.
Auto-ApplyMixing Operator III
Amneal Pharmaceuticals job in Brookhaven, NY
The Mixing Operator III is responsible for operation of the Mixing and Granulation equipment in accordance with Company Standard Operating Procedures and maintaining 100% cGMP & compliance to ensure the production of quality products.
Schedule:
1st Shift 7am - 3:30pm Monday to Friday
Essential Functions:
Perform & Verify complex equipment cleaning and operation of various types of industrial size mixing equipment.
Observes production and make sure all batches finished in time to meet monthly production target and monitors equipment to ensure safe and efficient operation.
Review PBR for correctness after Mixing and Granulation activities are complete, sign and hand over to Supervisor.
Make sure all equipment in the departments are grounded before starting any Batch. Follow daily Production Schedule and assign work accordingly.
Monitor ability and skill of Mixing & Granulation Operator Level -I and II and submit recommendations.
Education:
High School or GED General HS Curriculum - Preferred
Experience:
With HS/GED-5 years or more experience in Pharmaceuticals Manufacturing environment.
Less than HS/GED -6 years or more proven related experience in Pharmaceuticals Manufacturing environment.
Skills:
Required to read, write, and communicate in English
High school level math and mechanical skills
Flexible to work extended hours when required
Ability to work as part of a team
Attention to detail and accuracy
Specialized Knowledge:
Knowledge of High Shear Mixer, Fluid Bed Processor, GPCG-60 and 120, Hot Melt Extrusion, Hobart Mixer, Gral-600
The ideal candidate shall have the education, training, and experience, or any combination thereof as defined in this job description.
Additional Requirement: This position requires successful completion of an OSHA-compliant Respirator Fit Test.
The hourly base salary for this position is $24.00 - $25.00 per hour. Amneal ranges reflect the Company's good faith estimate of base salary that 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, 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 helps you enjoy your career alongside life's many other commitments and opportunities.
Auto-ApplyPurchasing Coordinator
Amneal Pharmaceuticals job in Brookhaven, NY
The Purchasing Coordinator will support the various departments with creating and maintaining purchase orders and manufacturing, repair, and operational supplies. This role will collaborate closely with engineers, project managers, and suppliers to source, negotiate, and monitor orders, ensuring adherence to industry regulations and the company's quality standards.
Schedule:
1st Shift -7am - 3:30pm Monday to Friday
Essential Functions:
Coordinate procurement of materials, spare parts, equipment, and services and contracts in support of facility operations and projects. Issue purchase orders, monitor order status, and expedite deliveries to meet project schedules.
Maintain accurate purchasing records and documentation in compliance with GMP and internal quality standards. Evaluate supplier performance and participate in vendor qualification and audits as needed. Maintain and finalize annual service contracts. Establish new vendors as needed, update vendor records, and ensure records and documentation comply with GMP, finance, and quality standards.
Maintain vendor relationships, conduct market research for quality and pricing, and negotiate prices. Coordinate with parts department, accounts payable, and vendors regarding material rejections, return processes, credit notes, and replacements.
Maintain employee lockers and uniforms in coordination with employees and vendors.
Develop key relationships with business stakeholders and ensure that purchase requisitions follow Company policies. Coordinate with various teams (internal & external) to resolve invoice discrepancies.
Collaborate with parts administration and maintenance teams to maintain critical parts availability. Generate daily, weekly, and monthly reports on inventory levels, procurement activities, and Capital Expenditure/Operating Expenditure (OPEX/CAPEX) expenditures to support informed decision-making by management.
Additional Responsibilities:
Performs other functions as required or assigned.
update vendor records via Coupa System in coordination with Accounts Payable and Procurement
Education:
Bachelors Degree (BA/BS) Engineering, Manufacturing or related field - Required
Experience:
2 years or more in Procurement
Skills:
Excellent interpersonal and organizational skills; - Intermediate
Ability to work with all levels within the company - Intermediate
Excellent verbal and written communication skills - Intermediate
Ability to multi-task - Intermediate
Specialized Knowledge:
Procurement 2 Pay Process, Inventory Management, GMP
The hourly base salary for this position ranges from $23.00 to $27.00 per hour. Amneal ranges reflect the Company's good faith estimate of base salary that 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, 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 helps you enjoy your career alongside life's many other commitments and opportunities.
Auto-ApplyCompression Operator I
Amneal Pharmaceuticals job in Brookhaven, NY
This entry-level role in the Compression Department is responsible for the setup and operation of compression machinery in accordance with company Standard Operating Procedures (SOPs). The Compression Operator ensures full compliance with cGMP standards to support the production of high-quality pharmaceutical products.
Schedule:
1st Shift 7am - 3:30pm Monday to Friday
$1,000 SIGN ON BONUS CURRENTLY BEING OFFERED FOR THIS OPENING
Essential Functions:
Responsible for conducting in-process checks including average weight, thickness, hardness, friability, and individual tablet weight, among others.
Initiates 'B' and 'A' level cleaning of compression rooms and ensures compliance with the In-Process Quality Assurance (IPQA) procedures.
Accurately identifies and segregates rejected blends and tablets, ensures required quality checks are completed, and upholds cleanliness and organization of the compression room and equipment to maintain compliance and operational efficiency.
Promptly notifies the Supervisor of any machine abnormalities or expired calibration status. Ensures weighing scales are kept clean and orderly for accurate calibration checks.
Verifies ingredients weighed in Mixing & Granulation against entries in the Production Batch Record (PBR), reporting any discrepancies to the Supervisor or designee. Responsible for real-time documentation across all Compression operations and for reviewing batch records to ensure accuracy.
Additional Responsibilities:
Other duties as assigned.
Flexible to work extended hours when required.
Education:
High School or GED General HS Curriculum - Preferred
Experience:
1 year or more in Experience in Pharmaceutical Manufacturing Environment
Skills:
Ability to read, write, and communicate in English. - Intermediate
High school level math and mechanical skills. - Intermediate
Ability to work as part of a team. - Intermediate
Attention to detail and accuracy. - Intermediate
Basic computer literacy with the ability to use web browsers, typing applications, Microsoft Office, and related communication tools. - Intermediate
Specialized Knowledge:
High speed Compression Machine set up preferred.
The hourly base salary for this position ranges from $17.50 to $23.50 per hour. Amneal ranges reflect the Company's good faith estimate of base salary that 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, 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 helps you enjoy your career alongside life's many other commitments and opportunities.
Auto-ApplyPharmacy Operator I - 2nd Shift
Amneal Pharmaceuticals, Inc. job in Brookhaven, NY
Entry-level role within the Pharmacy Department responsible for dispensing ingredients for mixing and granulation. Works under close supervision and required to know SOPs and cGMP. Essential Functions: * Responsible for accurately dispensing all materials as per batch record.
* Records and maintains the production batch records after each batch.
* Reviews and follows the batch records with 100% accuracy.
* Responsible for the pharmacy room to be clean, organized and ready for production.
* Responsible for maintaing inventory and reconciliation of materials.
* Ensures the cleanliness and checks calibration status of all scales, and balances.
Additional Responsibilities:
* Other duties as management assigns.
Auto-ApplyElectrician - 2nd Shift Tuesday to Saturday
Amneal Pharmaceuticals job in Brookhaven, NY
Electricians are responsible to maintain the facility electrical system in good working condition. Including Resetting Circuit Breakers, Changing Lamps and Ballasts, Light Sensors, Switches, Changing Receptacles, troubleshooting circuitry for Shorts and Opens.
Schedule:
3:30pm - 12:00am Tuesday to Saturday
Essential Functions:
Performs installation, modification, maintenance, and repair of high- and low-voltage electrical wiring systems and equipment, including outlets, air distribution systems, pumps, transformers, motors, streetlights, and appliances. Responds promptly to assigned work orders to ensure timely resolution of electrical issues.
Installs and services high-horsepower motors, coils, transformers, and control equipment; operates specialized tools and machinery required for the installation and repair of electrical systems.
Installs control systems and related devices and performs maintenance and repairs on equipment critical to 24-hour operations to ensure continuous and reliable functionality.
Records and maintains detailed documentation of preventive maintenance activities for electrical equipment and machinery, while overseeing and tracking the effectiveness of the preventive maintenance program.
Designs functional electrical circuitry for systems and creates single-line diagrams to illustrate control circuits.
Provides on-the-job training to junior or subordinate team members, ensuring proper understanding of electrical code standards and the requirements of specific tasks.
Consistently strives to enhance operations by reducing turnaround times, improving workflow efficiency, and fostering collaboration to deliver high-quality, seamless customer service.
Education:
High School or GED - Required
Experience:
Electrical construction and/or facility electrical experience
Skills:
Ability to distinguish between color-coded wiring, read and interpret wiring diagrams and blueprints, and reference electrical codes for proper installations. INTERMEDIATE
Ability to troubleshoot contactors, relays, and start/stop control systems. PROFICIENT
Operate equipment such as scissor lifts and forklifts. INTERMEDIATE
Specialized Knowledge:
Thorough understanding of the latest National Electrical Code (NEC) and applicable OSHA standards for both general industry and construction.
Proficient in wire color coding across all voltage systems, with hands-on experience working with 277/480V and 120/208/240V electrical systems.
Lic/Certification:
OSHA-10 Certificate Preferred
The hourly base salary for this position ranges from $28.00 to $37.00 per hour. Amneal ranges reflect the Company's good faith estimate of base salary that 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, 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 helps you enjoy your career alongside life's many other commitments and opportunities.
Auto-ApplySenior Repair & Maintenance Mechanic - 2nd Shift
Amneal Pharmaceuticals job in Brookhaven, NY
This senior role is responsible for ensuring optimal performance of production equipment through skilled maintenance, troubleshooting, and repair across multiple trades, including mechanical, electrical, pneumatic, and fabrication. Collaborates with management and production leadership to align maintenance efforts with operational goals, ensuring timely, safe, and high-quality execution of all tasks.
Schedule:
2nd Shift 3:30pm - 12:00am Monday to Friday
Essential Functions:
Execute repairs on equipment, utilities, and systems as directed by supervision. Perform advanced electrical troubleshooting, including Programmable Logic Controller (PLC) diagnostics, computerized equipment, along with mechanical maintenance and repairs.
Identifies required materials, equipment, parts, and supplies for maintenance tasks. Utilizes hand and power tools to test, inspect, troubleshoot, and repair machinery. Interprets blueprints, wiring diagrams, layouts, and technical specifications to perform accurate and effective repairs. Prepare recommended parts list for the manufacturing equipment.
Ensure adherence to safety protocols while monitoring and performing preventative maintenance and breakdown maintenance to support cost-effective operations. Implement and maintain a scheduled maintenance program in accordance with manufacturer specifications and recommendations. Plan and co-ordinate maintenance activities with production and ensure on-time solutions.
Train the maintenance personnel for maximum productivity. Direct mechanics in the use of safety equipment and procedures.
Maintain all equipment manuals, equipment warranties, and tool inventories. Review work orders to ensure proper documentation.
Additional Responsibilities:
Other jobs as assigned by management
Perform other tasks consistent with the goals and objectives of this position
Education:
High School or GED - Required
Experience:
5 years or more in Troubleshooting equipment in a pharmaceutical manufacturing environment
3 years or more in Experience working on compression & encapsulation equipment
Skills:
Ability to plan, organize and direct the work of skilled, semi-skilled, and unskilled employees engaged in repair and maintenance of equipment. - Beginner
Ability to coordinate programs, prepare reports and maintain accurate records. - Intermediate
Ability to troubleshoot, diagnose and repair equipment with accuracy and speed; ability to create effective working relationships with employees. - Advanced
Ability to communicate in English both orally and in writing. - Advanced
Ability to demonstrate initiative and proactive approach in carrying out assigned responsibilities. - Advanced
The hourly base salary for this position ranges from $30.00 to $40.00 per hour. Amneal ranges reflect the Company's good faith estimate of base salary that 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, 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 helps you enjoy your career alongside life's many other commitments and opportunities.
Auto-ApplySenior Scientist, Quality Control
Amneal Pharmaceuticals, Inc. job in Brookhaven, NY
The Scientist 3 - QC is responsible to perform testing of raw materials, in-process and finished pharmaceutical dosage forms, products on stability, cleaning verification samples following written procedures and applicable SOPs, calculate and report results on applicable specification documents, participate in method transfer activities within departments or between facilities or organizations. This role will also provide feedback on systems and analytical procedures to promote continuous improvement and enhancement of compliance posture.
Essential Functions:
* Perform physical and chemical analysis of raw materials, in-process, and finished pharmaceutical products, including products on stability, according to written methods, material specification, and company policies as identified in standard operating procedures (SOPs). Comply with cGMps, SOPs, and STPs to avoid out-of-specification situation. Assure compliance with state and federal regulations.
* 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.
* Use sonic sifter, laser diffraction, Karl Fischer, UV-Vis spectrophotometer, Infra-red spectrophotometer, HPLC with UV detection as well as with conductivity detection, TLC, pH meter, and dissolution. Calibrate HPLC, Dissolution apparatus equipped with auto-sampler and /or in-line UV, pH meters, analytical balances, and Karl-Fischer titrator.
* Document steps followed during analysis execution, calculate and report results. Actively participate in investigation of laboratory results.
* Review laboratory analysis data for completeness, specification compliance, and compliance with company's written policies.
* Report any abnormal findings to the 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.
Additional Responsibilities:
* Assist the laboratory supervisor with handling non-routine special projects requiring activities such as out-of-specification investigations and out-of-alert limit investigations in the laboratory.
* Ensure that expired chemicals and reference standards are removed from laboratory area.
* Perform calibration of HPLC, GC, and other equipment as assigned by the supervisor.
* Assist with hands-on training of newly hired Technicians or Scientists 1 and 2 levels.
Auto-ApplyField Clinical Specialist - Shockwave Medical (Nassau County)
Garden City, NY job
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at *******************
Job Function:
MedTech Sales
Job Sub Function:
Clinical Sales - Hospital/Hospital Systems (Commission)
Job Category:
Professional
All Job Posting Locations:
Garden City, New York, United States, Santa Clara, California, United States of America
Job Description:
Johnson & Johnson is hiring for a Field Clinical Specialist - Shockwave Medical to join our team in Garden City, NY
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for humanity. Learn more at *******************/.
Fueled by innovation at the intersection of biology and technology, we're developing the next generation of smarter, less invasive, more personalized treatments. Ready to join a team that's pioneering the development and commercialization of Intravascular Lithotripsy (IVL) to treat complex calcified cardiovascular disease. Our Shockwave Medical portfolio aims to establish a new standard of care for medical device treatment of atherosclerotic cardiovascular disease through its differentiated and proprietary local delivery of sonic pressure waves for the treatment of calcified plaque.
Position Overview
The Field Clinical Specialist is a visible position that will provide case support to physicians within certain territories. Case support will be done on peripheral and coronary interventional procedures in the pre-market and post-market phases of product development with the Shockwave Medical Intravascular Lithotripsy (IVL) technology. The Field Clinical Specialist will also play a critical role in clinical studies including device training, case support and ensuring timely data collection for clinical programs. Case support may be required to support other territories at certain times.
Essential Job Functions
* Physician and hospital staff training, and procedural case coverage to ensure the safe and effective use of medical devices.
* Effectively meet the needs of internal and external customers with a sense of urgency and drive.
* Present clinical study training materials based on investigational plans to support the safe and effective use of medical devices, inclining study protocol, instructions for use, core lab manuals and case report forms.
* Manage key study investigators; foster and maintain strong relationships through direct interactions with medical advisors and clinical leaders.
* Partner with other clinical research colleagues to meet business needs in the field including site re-training, data collection for timely database locks and resolution of critical issues.
* Administrative activities including training to procedures, manage territory travel and budgets.
* Other duties as assigned.
Requirements
* Minimum Bachelor's Degree in business, science, nursing or related fields, or equivalent experience.
* Minimum 2 years' experience directly supporting interventional or surgical procedures within a hospital setting OR, 1 year of industry, hospital-based life sciences, sales support experience. Cardiovascular industry experience preferred but not required.
* Working knowledge of clinical research, Good Clinical Practice (GCP) and regulatory compliance guidelines for clinical trials.
* A history of effective collaboration with regulatory agencies through clinical studies and market releases.
* Product knowledge including product vigilance and medical device reporting.
* High attention to detail and accuracy.
* Computer skills (MS Office products, word processing, spreadsheets, etc.).
* Finance and budgeting knowledge.
* Good prioritization and organizational skills.
* Excellent critical thinking skills.
* Excellent influencing and negotiation skills.
* High energy and results-oriented individual who is mature and successful in a business environment and is skilled in motivating and inspiring people.
* Entrepreneurial "hands-on" experience. Pro-active and "can do" attitude.
* Ability to consider and accept feedback and suggestions for continuous improvement.
* Works effectively on cross-functional teams. Demonstrated willingness to make decisions and to take responsibility for such.
* Effective written, verbal and presentation skills with all levels of customers and management.
* Ability to work in a fast-paced environment while managing multiple priorities
* Operate as a team and/or independently while demonstrating flexibility to changing requirements.
* There may be continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
* Significant travel >50% of time requiring the employee to be effective in a remote manner.
* Employee may be required to lift objects up to 40lbs or more. Employees will be required to work in an air conditioned office space and possibly perform some tasks in our non-temperature controlled warehouse space.
* Other duties as assigned.
Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.
Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, please contact us via *******************/contact-us/careers or contact AskGS to be directed to your accommodation resource.
The anticipated base pay range for this position is :
Base pay is $100,000 + variable compensation
Additional Description for Pay Transparency:
Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. Subject to the terms of their respective plans, employees are eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)). This position is eligible to participate in the Company's long-term incentive program. Subject to the terms of their respective policies and date of hire, Employees are eligible for the following time off benefits: Vacation -120 hours per calendar year Sick time - 40 hours per calendar year; for employees who reside in the State of Washington -56 hours per calendar year Holiday pay, including Floating Holidays -13 days per calendar year Work, Personal and Family Time - up to 40 hours per calendar year Parental Leave - 480 hours within one year of the birth/adoption/foster care of a child Condolence Leave - 30 days for an immediate family member: 5 days for an extended family member Caregiver Leave - 10 days Volunteer Leave - 4 days Military Spouse Time-Off - 80 hours Additional information can be found through the link below. *********************************************
Auto-ApplyAssociate Validation Engineer 1st Shift 8:30am-5:00pm
Amneal Pharmaceuticals, Inc. job in Brookhaven, NY
The Validation Engineer I provides support in performing equipment, facility and utility qualification activity and re-qualification activity to ensure compliance to cGMP and Amneal's quality requirements. Schedule: 1st Shift 8:30am - 5:00pm Monday to Friday - Fully Onsite
Essential Functions:
* Assist in the preparation/ execution of Installation Qualification(IQ)/Operational Qualification(OQ)/ Performance Qualification(PQ) protocols for equipment, facility and utilities as well as related software. Help generate qualification report and help summarize the results which will be reviewed by the supervisor
* Performs re-qualification of equipment, facility and utilities as required under supervision
* Identify deviations encountered during IQ/OQ/PQ execution and work with supervisor to implement mitigation solution
* Draft Standard Operating Procedure(SOP) for new operational equipment
* Supports process validation and cleaning validation by providing product contact surface area, equipment qualification parameter ranges and challenge tests criteria to technical service
* Works with equipment vendors to collect equipment manual and other required documents
* Closely works with the maintenance & facility teams to complete new equipment installation as per project requirement.
Additional Responsibilities:
* Assist with engineering projects and performs other duties as assigned.
Auto-ApplyQuality Assurance Inspector
Amneal Pharmaceuticals, Inc. job in Brookhaven, NY
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.
Schedule:
1st Shift 7:00am - 3:30pm Monday to Friday
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.
Auto-ApplyCoating Operator I - 2nd Shift
Amneal Pharmaceuticals job in Brookhaven, NY
Entry level role in the Coating Department. Coating Operator is responsible for safely operating the coating equipment and to ensure Coating Operations are completed in adherence to Standard Operating Procedures and maintaining 100% cGMP & compliance.
Schedule:
2nd Shift 3:30pm - 12:00am Monday to Friday
Essential Functions:
Records and maintains the production batch record during the coating operation.
Observes machine gauges and equipment calibration status and reports any deviations to Coating Supervisor.
Operates auxiliary equipment used in loading coating pans.
Cleans and organizes coating room, checks and verifies weight of tablets received from Compression, reports deviation.
Weighs and divides coating solution in number of parts as per production batch record.
Checks and verifies coating material dispensed by Pharmacy before making coating solution as per production batch record.
Additional Responsibilities:
Other duties as assigned.
Education:
High School or GED General HS Curriculum - Preferred
Experience:
1 year or more in Pharmaceuticals manufacturing experience
Skills:
Required to read, write, and communicate in English. - Intermediate
Flexible to work extended hours when required. - Intermediate
Ability to work as part of a team. - Intermediate
Attention to accuracy and detail. - Intermediate
The hourly base salary for this position ranges from $17.50 to $23.50 per hour. Amneal ranges reflect the Company's good faith estimate of base salary that 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, 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 helps you enjoy your career alongside life's many other commitments and opportunities.
Auto-ApplyPharmacy Operator I - 2nd Shift
Amneal job in North Bellport, NY
Entry-level role within the Pharmacy Department responsible for dispensing ingredients for mixing and granulation. Works under close supervision and required to know SOPs and cGMP.
Essential Functions:
Responsible for accurately dispensing all materials as per batch record.
Records and maintains the production batch records after each batch.
Reviews and follows the batch records with 100% accuracy.
Responsible for the pharmacy room to be clean, organized and ready for production.
Responsible for maintaing inventory and reconciliation of materials.
Ensures the cleanliness and checks calibration status of all scales, and balances.
Additional Responsibilities:
Other duties as management assigns.
Qualifications
Education:
High School or GED General HS Curriculum - Preferred
Experience:
Less than one year in Pharmaceuticals manufacturing experience
Skills:
Required to read, write, and communicate in English. - Intermediate
High school level math and mechanical skills. - Intermediate
Flexible to work extended hours when required. - Intermediate
Ability to work as part of a team with understanding of monthly goals. - Intermediate
Attention to detail and accuracy. - Intermediate
Additional Requirement: This position requires successful completion of an OSHA-compliant Respirator Fit Test.
The hourly base salary for this position ranges from $17.50 to $18.50 per hour. Amneal ranges reflect the Company's good faith estimate of base salary that 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, 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 helps you enjoy your career alongside life's many other commitments and opportunities.
Auto-ApplyPharmacy Operator I - 2nd Shift
Amneal Pharmaceuticals job in Brookhaven, NY
Entry-level role within the Pharmacy Department responsible for dispensing ingredients for mixing and granulation. Works under close supervision and required to know SOPs and cGMP.
Essential Functions:
Responsible for accurately dispensing all materials as per batch record.
Records and maintains the production batch records after each batch.
Reviews and follows the batch records with 100% accuracy.
Responsible for the pharmacy room to be clean, organized and ready for production.
Responsible for maintain inventory and reconciliation of materials.
Ensures the cleanliness and checks calibration status of all scales, and balances.
Additional Responsibilities:
Other duties as management assigns.
Education:
High School or GED General HS Curriculum - Preferred
Experience:
less than one year in Pharmaceuticals manufacturing experience
Skills:
Required to read, write, and communicate in English. - Intermediate
High school level math and mechanical skills. - Intermediate
Flexible to work extended hours when required. - Intermediate
Ability to work as part of a team with understanding of monthly goals. - Intermediate
Attention to detail and accuracy. - Intermediate
Additional Requirement: This position requires successful completion of an OSHA-compliant Respirator Fit Test.
The hourly base salary for this position ranges from $17.50 to $18.50 per hour. Amneal ranges reflect the Company's good faith estimate of base salary that 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, 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 helps you enjoy your career alongside life's many other commitments and opportunities.
Auto-ApplyCompression Operator I
Amneal job in North Bellport, NY
This entry-level role in the Compression Department is responsible for the setup and operation of compression machinery in accordance with company Standard Operating Procedures (SOPs). The Compression Operator ensures full compliance with cGMP standards to support the production of high-quality pharmaceutical products.
Schedule:
1st Shift 7am - 3:30pm Monday to Friday
$1,000 SIGN ON BONUS CURRENTLY BEING OFFERED FOR THIS OPENING
Essential Functions:
Responsible for conducting in-process checks including average weight, thickness, hardness, friability, and individual tablet weight, among others.
Initiates 'B' and 'A' level cleaning of compression rooms and ensures compliance with the In-Process Quality Assurance (IPQA) procedures.
Accurately identifies and segregates rejected blends and tablets, ensures required quality checks are completed, and upholds cleanliness and organization of the compression room and equipment to maintain compliance and operational efficiency.
Promptly notifies the Supervisor of any machine abnormalities or expired calibration status. Ensures weighing scales are kept clean and orderly for accurate calibration checks.
Verifies ingredients weighed in Mixing & Granulation against entries in the Production Batch Record (PBR), reporting any discrepancies to the Supervisor or designee. Responsible for real-time documentation across all Compression operations and for reviewing batch records to ensure accuracy.
Additional Responsibilities:
Other duties as assigned.
Flexible to work extended hours when required.
Qualifications
Education:
High School or GED General HS Curriculum - Preferred
Experience:
1 year or more in Experience in Pharmaceutical Manufacturing Environment
Skills:
Ability to read, write, and communicate in English. - Intermediate
High school level math and mechanical skills. - Intermediate
Ability to work as part of a team. - Intermediate
Attention to detail and accuracy. - Intermediate
Basic computer literacy with the ability to use web browsers, typing applications, Microsoft Office, and related communication tools. - Intermediate
Specialized Knowledge:
High speed Compression Machine set up preferred.
The hourly base salary for this position ranges from $17.50 to $23.50 per hour. Amneal ranges reflect the Company's good faith estimate of base salary that 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, 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 helps you enjoy your career alongside life's many other commitments and opportunities.
Auto-ApplySenior Repair & Maintenance Mechanic - 2nd
Amneal Pharmaceuticals, Inc. job in Brookhaven, NY
This senior role is responsible for ensuring optimal performance of production equipment through skilled maintenance, troubleshooting, and repair across multiple trades, including mechanical, electrical, pneumatic, and fabrication. Collaborates with management and production leadership to align maintenance efforts with operational goals, ensuring timely, safe, and high-quality execution of all tasks.
Schedule:
2nd Shift 3:30pm - 12:00am Monday to Friday
Essential Functions:
* Execute repairs on equipment, utilities, and systems as directed by supervision. Perform advanced electrical troubleshooting, including Programmable Logic Controller (PLC) diagnostics, computerized equipment, along with mechanical maintenance and repairs.
* Identifies required materials, equipment, parts, and supplies for maintenance tasks. Utilizes hand and power tools to test, inspect, troubleshoot, and repair machinery. Interprets blueprints, wiring diagrams, layouts, and technical specifications to perform accurate and effective repairs. Prepare recommended parts list for the manufacturing equipment.
* Ensure adherence to safety protocols while monitoring and performing preventative maintenance and breakdown maintenance to support cost-effective operations. Implement and maintain a scheduled maintenance program in accordance with manufacturer specifications and recommendations. Plan and co-ordinate maintenance activities with production and ensure on-time solutions.
* Train the maintenance personnel for maximum productivity. Direct mechanics in the use of safety equipment and procedures.
* Maintain all equipment manuals, equipment warranties, and tool inventories. Review work orders to ensure proper documentation.
Additional Responsibilities:
* Other jobs as assigned by management
* Perform other tasks consistent with the goals and objectives of this position
Auto-ApplyElectrician - 2nd Shift Tuesday to Saturday
Amneal job in North Bellport, NY
Electricians are responsible to maintain the facility electrical system in good working condition. Including Resetting Circuit Breakers, Changing Lamps and Ballasts, Light Sensors, Switches, Changing Receptacles, troubleshooting circuitry for Shorts and Opens.
Schedule:
3:30pm - 12:00am Tuesday to Saturday
Essential Functions:
Performs installation, modification, maintenance, and repair of high- and low-voltage electrical wiring systems and equipment, including outlets, air distribution systems, pumps, transformers, motors, streetlights, and appliances. Responds promptly to assigned work orders to ensure timely resolution of electrical issues.
Installs and services high-horsepower motors, coils, transformers, and control equipment; operates specialized tools and machinery required for the installation and repair of electrical systems.
Installs control systems and related devices and performs maintenance and repairs on equipment critical to 24-hour operations to ensure continuous and reliable functionality.
Records and maintains detailed documentation of preventive maintenance activities for electrical equipment and machinery, while overseeing and tracking the effectiveness of the preventive maintenance program.
Designs functional electrical circuitry for systems and creates single-line diagrams to illustrate control circuits.
Provides on-the-job training to junior or subordinate team members, ensuring proper understanding of electrical code standards and the requirements of specific tasks.
Consistently strives to enhance operations by reducing turnaround times, improving workflow efficiency, and fostering collaboration to deliver high-quality, seamless customer service.
Qualifications
Education:
High School or GED - Required
Experience:
Electrical construction and/or facility electrical experience
Skills:
Ability to distinguish between color-coded wiring, read and interpret wiring diagrams and blueprints, and reference electrical codes for proper installations. INTERMEDIATE
Ability to troubleshoot contactors, relays, and start/stop control systems. PROFICIENT
Operate equipment such as scissor lifts and forklifts. INTERMEDIATE
Specialized Knowledge:
Thorough understanding of the latest National Electrical Code (NEC) and applicable OSHA standards for both general industry and construction.
Proficient in wire color coding across all voltage systems, with hands-on experience working with 277/480V and 120/208/240V electrical systems.
Lic/Certification:
OSHA-10 Certificate Preferred
The hourly base salary for this position ranges from $28.00 to $37.00 per hour. Amneal ranges reflect the Company's good faith estimate of base salary that 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, 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 helps you enjoy your career alongside life's many other commitments and opportunities.
Auto-ApplySenior Scientist, Quality Control
Amneal Pharmaceuticals job in Brookhaven, NY
The Scientist 3 - QC is responsible to perform testing of raw materials, in-process and finished pharmaceutical dosage forms, products on stability, cleaning verification samples following written procedures and applicable SOPs, calculate and report results on applicable specification documents, participate in method transfer activities within departments or between facilities or organizations. This role will also provide feedback on systems and analytical procedures to promote continuous improvement and enhancement of compliance posture.
Essential Functions:
Perform physical and chemical analysis of raw materials, in-process, and finished pharmaceutical products, including products on stability, according to written methods, material specification, and company policies as identified in standard operating procedures (SOPs). Comply with cGMps, SOPs, and STPs to avoid out-of-specification situation. Assure compliance with state and federal regulations.
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.
Use sonic sifter, laser diffraction, Karl Fischer, UV-Vis spectrophotometer, Infra-red spectrophotometer, HPLC with UV detection as well as with conductivity detection, TLC, pH meter, and dissolution. Calibrate HPLC, Dissolution apparatus equipped with auto-sampler and /or in-line UV, pH meters, analytical balances, and Karl-Fischer titrator.
Document steps followed during analysis execution, calculate and report results. Actively participate in investigation of laboratory results.
Review laboratory analysis data for completeness, specification compliance, and compliance with company's written policies.
Report any abnormal findings to the 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.
Additional Responsibilities:
Assist the laboratory supervisor with handling non-routine special projects requiring activities such as out-of-specification investigations and out-of-alert limit investigations in the laboratory.
Ensure that expired chemicals and reference standards are removed from laboratory area.
Perform calibration of HPLC, GC, and other equipment as assigned by the supervisor.
Assist with hands-on training of newly hired Technicians or Scientists 1 and 2 levels.
Education:
Bachelors Degree (BA/BS) Chemistry or related science discipline - Required
Master Degree (MS/MA) Chemistry or related science discipline - Preferred
Experience:
With a Bachelors Degree (BA/BS) -5 years or more of testing of chemicals/pharmaceutical products
With a Masters Degree (BA/BS) -3 years or more of testing of chemicals/pharmaceutical products
Skills:
Must be precise and consistent in day to day analysis, easily trainable and ready to learn. - Advanced
Must be able to work in a team environment and be flexible to easily adapt to changes in assignments. - Advanced
Must be able to execute compendial procedures involving complexity with no or minimal supervision. - Intermediate
Must be able to effectively communicate results, problems or issues, verbally as well as in writing. - Intermediate
Must be able to assume a role of a leader in team environment as and when required. - Intermediate
Must be computer literate and savvy with MS office applications, software programs related to LIMS. - Intermediate
Must be willing to work extended hours, including weekends, as and when required. - Intermediate
Must follow safe practices as identified in appropriate MSDS during working with chemicals, and must follow applicable state and federal regulations. - Advanced
Must be capable of maintaining clear and concise laboratory records and communicating clearly both within and between departments. - Advanced
Must be thoroughly familiar with cGMP applicable to laboratories in pharmaceutical settings and with method verification/validation concepts. - Advanced
Must be able to review laboratory records to ascertain compliance with applicable specifications, methods, and SOPs. - Intermediate
Specialized Knowledge:
Must possess in-depth knowledge of analytical chemistry techniques, such as spectrophotometric, dissolution and drug release, chromatographic techniques (standalone or hypenated) and measuring physical parameters (viscosity, particle size or droplet size by laser diffraction, melting point by DSC, water content by TGA, identification by XRPD, and other techniques).
Must be able to follow compendial (USP/EP/BP/JP) procedures for analysis.
Must understand and apply cGMP requirements applicable to quality control laboratory.
Must have ability to apply advanced technical skills to troubleshoot and resolve complex analytical and instrument-related problems effectively and in a timely manner and report actions to the laboratory management in a timely manner.
Must be able to identify trends in analytical data.
The base salary for this position ranges from $90,000 to $95,000 per year. Amneal ranges reflect the Company's good faith estimate of base salary that 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, 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 helps you enjoy your career alongside life's many other commitments and opportunities.
Auto-ApplyAssociate Validation Engineer 1st Shift 8:30am-5:00pm
Amneal job in North Bellport, NY
The Validation Engineer I provides support in performing equipment, facility and utility qualification activity and re-qualification activity to ensure compliance to cGMP and Amneal's quality requirements.
Schedule:
1st Shift 8:30am - 5:00pm Monday to Friday - Fully Onsite
Essential Functions:
Assist in the preparation/ execution of Installation Qualification(IQ)/Operational Qualification(OQ)/ Performance Qualification(PQ) protocols for equipment, facility and utilities as well as related software. Help generate qualification report and help summarize the results which will be reviewed by the supervisor
Performs re-qualification of equipment, facility and utilities as required under supervision
Identify deviations encountered during IQ/OQ/PQ execution and work with supervisor to implement mitigation solution
Draft Standard Operating Procedure(SOP) for new operational equipment
Supports process validation and cleaning validation by providing product contact surface area, equipment qualification parameter ranges and challenge tests criteria to technical service
Works with equipment vendors to collect equipment manual and other required documents
Closely works with the maintenance & facility teams to complete new equipment installation as per project requirement.
Additional Responsibilities:
Assist with engineering projects and performs other duties as assigned.
Qualifications
Education:
Bachelors Degree (BA/BS) Degree in Pharmaceutical manufacturing, Engineering, Science or relevant field - Required
Experience:
0-2 years of experience in Engineering, Pharmaceutical Industry, cGMP environment with Bachelor's degree.
1 year or more in Experience in Engineering, Pharmaceutical Industry, cGMP environment without Bachelor's degree.
Skills:
Proficient in MS Office. - Advanced
Excellent technical writing skills. - Intermediate
Excellent oral and written communication skills. - Intermediate
Must be able for follow direction and execute assigned work independently, after initial training is completed. - Intermediate
Ability to work both independently and in conjunction with a team - Advanced
Additional Requirement: This position requires successful completion of an OSHA-compliant Respirator Fit Test.
The base salary for this position ranges from $65,000 to $75,000 per year. Amneal ranges reflect the Company's good faith estimate of base salary that 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, 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 helps you enjoy your career alongside life's many other commitments and opportunities.
Auto-ApplyQuality Assurance Inspector
Amneal job in North Bellport, NY
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.
Schedule:
1st Shift 7:00am - 3:30pm Monday to Friday
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.
Qualifications
Education:
High School or GED - Required
Experience:
1 year or more in 1 year in QA or related field
Skills:
High energy level and organizational skills. - Advanced
A certain degree of creativity and latitude is required. - Intermediate
Basic computer skills (Word and Excel ) - Intermediate
Specialized Knowledge:
Good basic math knowledge and excellent attention to details.
Records observations for improving processes.
Licenses:
The hourly base salary for this position ranges from $19.00 to $23.00 per hour. Amneal ranges reflect the Company's good faith estimate of base salary that 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, 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 helps you enjoy your career alongside life's many other commitments and opportunities.
Auto-Apply