QA Reviewer

4 days ago


East Windsor, United States ANI Pharmaceuticals, Inc. Full time

**About Us**

Welcome to ANI Pharmaceuticals, where we are dedicated to improving and enhancing patients' lives through the manufacturing and distribution of high-quality pharmaceutical products.

With a diverse portfolio of generic and branded pharmaceuticals, ANI is a trusted partner for healthcare providers, pharmacists, and patients alike. We understand the importance of accessibility, and our products are available across a wide range of therapeutic areas, contributing to the well-being of communities globally.

**About the Role**

This is an opportunity to join the QA team at the East Windsor, NJ facility. The position is Monday through Friday from 8:00 a.m. to 5:00 p.m. This position will follow and ensure compliance with current GMP requirements and all SOPs.

**Responsibilities**:

- Review batch records online to ensure batch entries are made correctly.
- Oversee that all materials are weighed correctly before initiation of the manufacturing process.
- Review all stages of the batch record and ensure manufacturing and packaging are carried out correctly. Identify if any out-of-limit results are recorded.
- Monitor production areas for compliance with SOPs, cGMP, and safety requirements.
- Review electronic data and find if there are any non-compliances with the batch process.
- Follow and comply with SOP and batch record requirements. Ensure batches are manufactured according to the SOP and batch record requirements.
- Identify and resolve routine errors that occur during manufacturing and packaging. Prevent possible deviations that affect production in real-time.
- Ensure validation batches are manufactured as per the protocol requirements.
- Perform in-process checks as necessary while manufacturing and packaging of intermediate and finished product batches.

**Skills**:

- Understand the quality and safety requirements according to FDA regulations and the SOPs.
- The ability to understand and follow all defined SOPs.
- Communicate work-related issues and details effectively with the supervisor and team members.

**Requirements**:

- Hold a degree in science or life sciences with a bachelor’s degree preferred.
- 5-7 years of experience working in the pharmaceutical or related industry.
- Knowledgeable about all FDA regulations and the ability to adhere to SOPs.

Fz92K6G75L



  • East Greenbush, United States Regeneron Pharmaceuticals Inc. Full time

    The QA Validation department is hiring! This team supports validation of equipment, utilities, software, cleaning and sterilization processes at Regeneron’s Rensselaer facility in accordance with regulatory requirements implementing company manufacturing standard policies and procedures. **In this role, a typical day may include**: Generates, executes...

  • QA Analyst I

    2 weeks ago


    Windsor, United States Vertafore Full time

    $24.04 / hour Vertafore is a leading technology company whose innovative software solutions are advancing the insurance industry. Our suite of products provides solutions to our customers that help them better manage their business, boost their productivity and efficiencies, and lower costs while strengthening relationships. Our mission is to move...


  • Windsor Locks, United States LanceSoft Full time

    Description: The agency needs the service of a 1 HANDS ON QA Automation Engineer. The candidate will serve in the capacity of a QA Automation Engineer, will follow a well-defined vision of how IT and the business aligns and make sure that everyone is following the same principles, methodologies, and support activities per the direction of agency management....

  • Lead QA Admin

    2 weeks ago


    East Lansing, Michigan, United States MAXIMUS Full time

    & Requirements Maximus is currently hiring for a Lead QA Admin to support our Michigan Enrollment Services team. The Lead QA Admin is responsible for assisting the QA & Compliance Manager with analyzing and documenting project and stakeholder requirements related to quality and oversight and refinement of quality analytical systems (CallMiner). Essential...

  • QA Automation Tester

    1 month ago


    Windsor Locks, United States Mavensoft Technologies Full time

    Job Title:QA Automation Tester Duration: 6 Months (contract) Location: Hartford, CT (Hybrid ) Key Skills: Azure - Test Management Tool, Azure DevOps suite (Azure Boards, Azure Repos, Azure Pipelines, Azure Test Plans, Azure Artifacts), UFT (Unified Functional Testing) and VBScript, Automated Testing Frameworks, Agile Methodologies and MS SQL server. Local...


  • East Brunswick, New Jersey, United States Atlas Systems Full time

    Job Description Job Description Salary:About Atlas SystemsAtlas Systems, established in 2003, is a leading IT services company that prides itself on delivering innovative technology solutions across various industries. Celebrating 20 years of excellence, the company focuses on digital transformation, cloud & infrastructure services, health provider directory...

  • QA Specialist

    1 week ago


    East Greenbush, United States Regeneron Pharmaceuticals Inc. Full time

    The Quality Assurance, Raw Materials department at Regeneron is adding to their team! The QA Specialist - Raw Materials, performs activities in support of disposition product and/or raw materials while ensuring compliance with Quality Assurance (QA) policies and procedures, cGMPs, SOPs, and Regeneron Standard Requirement Documents. **Shift Available**:...


  • East Haven, United States Lingo Staffing Full time

    Job DescriptionJob DescriptionLingo Staffing is hiring a QA Packaging Technician in East Haven, CT!***This is a fast growing company with room for advancement***Starting pay: $15.69/hour with a review and performance based raise after 90 days. Hours: 7:30am-4PM Responsibilities include:Assist with regular checks on packaging lines, including inspecting fill...

  • QA Specialist

    3 weeks ago


    East Greenbush, United States Regeneron Pharmaceuticals Inc. Full time

    We are currently looking to fill multiple Quality Assurance Specialist (Drug Product) positions. These positions will support Quality Assurance initiatives for a broad range of topics relative to the start-up and operations of a Drug Product facility. **Available Work Schedules**: Wednesday-Saturday, 2nd shift (4x10) Monday-Friday, 2nd shift **In this...


  • East Greenbush, United States Regeneron Pharmaceuticals Inc. Full time

    The QA Material & Supplier Specialist - Raw Material Qualification implements activities within the material qualification program to support the utilization of raw materials in Drug Substance and Drug Product Manufacturing. **In this role, a typical day might include the following**: Performing activities associated with qualification of raw materials such...


  • East Brunswick, New Jersey, United States US Pharma Lab Full time

    Job DescriptionDate 03/2023 Location 1300 Airport Road, North Brunswick NJ Title Lead, QA Associate (Operation) Department Quality Assurance Reports to Manager, Quality Assurance FLSA (Exempt or Non-Exempt Non-Exempt Role Overview The Lead QA Associate performs line inspections as part of the cGMP's, SOPs, and policy compliance requirements. Performs...


  • East Windsor, United States Empower Pharmacy Full time

    Position Summary: As the Director, Quality 503B at Empower, you will be a cornerstone of our commitment to excellence in pharmaceutical manufacturing. Your role is vital in maintaining the integrity of our drug preparation processes and ensuring compliance with stringent government regulations and standards for current Good Manufacturing Practices (cGMPs)...

  • QA Manager

    2 weeks ago


    East Brunswick, United States On Target Staffing LLC Full time

    Job DescriptionJob DescriptionQUALITY  ASSURANCE MANAGER NEEDEDMON-FRI 8AM-4:30PMQualificationsFDA Audit experience required5+ years in QA/QC and ComplianceHACCP certification or the ability to write a HACCP planAbility to adapt to frequent changes, unexpected events and still yield an effective outcomeAbility to use MS Word, Excel, Outlook, ERP, quality...

  • Manager QA Validation

    3 weeks ago


    East Greenbush, United States Regeneron Pharmaceuticals Inc. Full time

    The QA Validation team is hiring a Manager to lead the department responsible for qualification of equipment, utilities, software, and validation of cleaning and sterilization processes in Regeneron's facilities. **In this role, a typical day may include**: Designs and develops policies related to validation and ensures that they are effectively...


  • East Windsor, United States Crystal Pharmatech Full time

    Job DescriptionJob DescriptionCrystal Pharmatech Inc. - Cranbury, NJ, USA  Job DescriptionThe Quality Assurance Specialist will report to the Head of Small Molecule Division. The candidate will be in charge of all quality assurance activities at the site, including maintenance of the SOPs, site preparation for client audits, review of GMP data, quality...


  • East Windsor, United States Empower Pharmacy Full time

    Position Summary: At Empower, the role of a Manufacturing Specialist of Quality Assurance (MQA) is pivotal in upholding our commitment to excellence in medication production. This position is integral to ensuring our manufacturing processes adhere to the highest standards of safety and quality. As an MQA, you will be at the heart of our operations,...

  • SAP Re-Insurance

    4 weeks ago


    East Brunswick, United States SHIRO Technologies Inc Full time

    Job DescriptionJob DescriptionCompany DescriptionSHIRO TECHNOLOGIES LLC is a multidimensional global technology services and outsourcing company. We are a critical source for innovative, bespoke IT solutions. We are focused on advancing technology, and by leveraging our years of industry experience, consummate capabilities across all industries and business...

  • Associate Manager QA

    3 weeks ago


    East Greenbush, United States Regeneron Pharmaceuticals Inc. Full time

    We are currently looking to fill an Associate Manager QA (Visual Inspection) position. This position is responsible for the leadership, development, and oversight of the Quality Assurance team supporting Visual Inspection operations at Regeneron’s internal Fill/Finish facility. This position will also contribute to establishing procedures and policies...

  • Engineer I, Quality

    1 month ago


    East Windsor, United States Shiseido Full time

    Job Summary: The Quality Engineer is responsible for defining and addressing Quality Improvement opportunities in all GMP areas. Has extensive knowledge of cGMPs and quality processes and procedures and accountable for the Annual Product Quality Review (APQR) and investigations for non-conforming products and materials.   Primary Duties &...


  • East Windsor, United States Shiseido Full time

    Job Summary: (Describe the purpose of the job. Provide a brief overview in 3-4 sentences) Lead the team responsible for scheduling filling/packaging operations to ensure the creation & timely execution of an efficient production schedule. Primary Duties & Responsibilities: (List what are the main tasks) Manage the finished good short-term planning...