Associate Specialist, Quality Product Release-Disposition

2 weeks ago


Summit, United States Omni Inclusive Full time

100% onsite
Work Schedule- 11 am to 7:30 pm- Mon-Fri

Position Title: Associate Specialist, Quality Product Release-Disposition
Location: Summit West, S-12

PURPOSE AND SCOPE OF POSITION:
The Associate Specialist is responsible for activities in accordance with corporate policies, standards, procedures, and Global cGMP in support of the QA Disposition group. Functional responsibilities include but are not limited to, ensuring accurate and timely maintenance and review of quality records and manufacturing documentation, inventory management for quality records and manufacturing documentation. Additionally, Associate Specialist supports the receipt of executed batch records and the scanning and uploading of documents and may also support document redaction and document printing.

REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities:
• Must have knowledge and experience with cGMP manufacturing, Quality, and compliance.
• Must possess an independent mindset.
• Work is self-directed.
• Confident in making decisions for non-routine issues.
• Proposes solutions for issues and works with management to resolve. Follows established procedures and performs work as assigned.
• Understands continuous improvement and improves efficiency and productivity within the group or project.
• Builds relationships internally within and with cross functional teams.
• Able to prepare written communications and communicate problems to Supervisors with clarity and accuracy.
• Able to effectively multi-task.
• Knowledge of US and global cGMP requirements.
• Excellent verbal and written communication skills.
Education and Experience: • B.S degree with 1-3 years GMP experience in the Pharmaceutical or related industry.
• Equivalent combination of education and experience acceptable.

DUTIES AND RESPONSIBILITIES:
• Supports the receiving of executed batch records .
• Supports the scanning and uploading of quality records.
• Must be skilled in planning and organizing, decision-making, and building relationships.
• Contributes to the goals within the work group.
• Teamwork and ability to work effectively across functional groups and teams to ensure requirements are met.
• Able to effectively multi-task.

WORKING CONDITIONS (US Only):
Work is performed in a typical office environment, with standard office equipment available and used. Work is generally performed seated but may require standing and walking for up to 10% of the time. Lighting and temperature are adequate and there are no abnormal conditions caused by noise, dust, etc.

This job description is intended to describe the general nature and level of work being performed by the person assigned to this position. The primary duties and responsibilities are intended to describe those functions that are essential to the performance of this job.
This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. There are other duties and responsibilities that are considered incidental or secondary to the overall purpose of this job. Employees holding this position will be required to perform any other job-related duties as requested by management.



  • Summit, United States Sunrise System Inc Full time

    Job Title: Quality Assurance Specialist Job ID: 24-03496 Location: Summit, NJ, 07901 Duration: 12 Months contract on W2 Job Description: 50% onsite PURPOSE AND SCOPE OF POSITION (Position Summary): The Quality Assurance Specialist position plays a key role in supporting the cGMP quality operations for the Vector External Manufacturing....


  • Summit, United States Sunrise System Inc Full time

    Job Title: Quality Assurance Specialist Job ID: 24-03496 Location: Summit, NJ, 07901 Duration: 12 Months contract on W2 Job Description: 50% onsite PURPOSE AND SCOPE OF POSITION (Position Summary): The Quality Assurance Specialist position plays a key role in supporting the cGMP quality operations for the Vector External Manufacturing....


  • Summit, New Jersey, United States Sunrise System Inc Full time

    Job Title: Quality Assurance Analyst Company: Sunrise System Inc Location: Summit, NJ Duration: 12 Months contract on W2 POSITION SUMMARY: The Quality Assurance Analyst is integral to upholding the cGMP quality standards for Vector External Manufacturing. Key responsibilities encompass the examination of cGMP Controlled Documents, including SOPs,...


  • Summit, United States SSi People Full time

    Education:Bachelor’s degree in a relevant science or engineering disciplineExperience:cGMP experience. Experience in FDA/EMA regulations in biopharmaceuticals or cell therapy manufacturing is preferred.Hands-on experience with batch record review and product disposition is preferred.Strong computer skills with Word and Excel and other electronic...


  • Summit, United States SSi People Full time

    Education:Bachelor’s degree in a relevant science or engineering disciplineExperience:cGMP experience. Experience in FDA/EMA regulations in biopharmaceuticals or cell therapy manufacturing is preferred.Hands-on experience with batch record review and product disposition is preferred.Strong computer skills with Word and Excel and other electronic...


  • Summit, United States Bristol Myers Squibb Full time

    Working with UsChallenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the...


  • Summit, New Jersey, United States ECLARO Full time

    JOB TITLE: Quality Control AnalystLocation: Hybrid PositionDuration: Initial contract with potential for extension or conversionPosition Overview:The Quality Control Analyst is essential in ensuring adherence to cGMP quality operations within the Vector External Manufacturing framework. Key responsibilities encompass the evaluation of cGMP Controlled...


  • Summit, United States Futran Solutions Inc Full time

    Job Description: 100% onsiteThe QC Analyst is responsible for supporting Quality Control bioanalytical testing for release of clinical and commercial productsThis includes the ability to interface with multiple groups, the ability to independently perform tasks, interpret results, and troubleshootAdditionally, when needed, this position will be able to...


  • Summit, United States Bristol Myers Squibb Full time

    Working with UsChallenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the...


  • Summit, United States Bristol Myers Squibb Full time

    Working with UsChallenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the...


  • Holts Summit, United States PFSbrands Full time

    FOOD QUALITY SPECIALISTReports to: Deli Manager SUMMARYThe Food Quality Specialist goes above and beyond to exceed expectations and ensure that all guests experience genuine customer service, great tasting food and leave with a smile.Generally, the job duties consist of preparing, seasoning, and cooking food to specifications. Food Quality Specialists may...

  • Freight Specialist

    6 days ago


    Lee's Summit, United States Boise Cascade Company Full time

    Job DescriptionJob DescriptionBoise Cascade Company has been in the business of manufacturing wood products and distributing building materials for over half a century. We are one of the largest producers of engineered wood products and plywood in North America and a leading U.S. wholesale distributor of building materials. Because our business is built on...


  • Clarks Summit, Pennsylvania, United States Alleima Full time

    About the RoleWe are seeking a highly skilled and versatile Multi-Skilled Production Specialist to join our team at Alleima. As a key member of our production team, you will play a critical role in ensuring the smooth operation of our manufacturing processes.Key Responsibilities:Equipment Operation and Maintenance: Safely operate and maintain all relevant...


  • Summit, United States Aequor Full time

    Job ID: 59497-1Position: Quality Control TechnicianLocation: Summit, NJ 07901Duration: 12 months 100% on-siteThe QC Analyst is responsible for supporting Quality Control bioanalytical testing for the release of clinical and commercial products. This includes the ability to interface with multiple groups, the ability to independently perform tasks, interpret...


  • Lee's Summit, Missouri, United States Elwood Staffing Full time

    **Job Summary**Elwood Staffing is seeking a skilled Assembly Production Specialist to join our team in Lee's Summit, MO. As a premier designer and manufacturer of outdoor property clean-up products, we are looking for a talented individual to work on our production line.**Key Responsibilities:**Assemble and manufacture outdoor property clean-up products,...


  • Summit, United States Crox Consulting Inc Full time

    REQUIRED COMPETENCIES:Knowledge, Skills, and Abilities:• Working experience of deviation investigations utilizing root cause analysis tools.• Working experience in the CAPA process and ability to identify and verify effectiveness.• Technical writing skills and ability to collaborate effectively in cross functional teams.• Proven ability to accurately...


  • Summit, United States Crox Consulting Inc Full time

    REQUIRED COMPETENCIES:Knowledge, Skills, and Abilities:• Working experience of deviation investigations utilizing root cause analysis tools.• Working experience in the CAPA process and ability to identify and verify effectiveness.• Technical writing skills and ability to collaborate effectively in cross functional teams.• Proven ability to accurately...


  • Browns Summit, North Carolina, United States Alamance Foods Full time

    Quality Assurance TechnicianThe role of a Quality Assurance Technician is vital in upholding the standards of our products during the manufacturing process. These technicians are positioned along the production line to assist all team members in ensuring adherence to quality benchmarks.Oversee the speed of production on the assembly linePerform visual...


  • Browns Summit, North Carolina, United States Aerotek Full time

    JOIN OUR TEAM AS A QUALITY ASSURANCE SPECIALISTCOMPENSATION: $19-20/HR. TO START WITH OPPORTUNITIES FOR INCREASES*** CANDIDATES MUST HAVE RECENT EXPERIENCE IN QUALITY ASSURANCE ROLES ***SCHEDULE: NIGHT SHIFT 7 PM - 7 AM ON A 2-2-3 ROTATIONPosition Overview: Seeking individuals with a background in quality inspection or quality assurance roles. Proficient in...


  • Summit, United States Sunrise Systems Inc Full time

    Job Title: Quality Control Technician Job ID: 24-03880 Location: Summit, NJ, 07901 Duration: 12 Months contract on W2 100% onsite The QC Analyst is responsible for supporting Quality Control bioanalytical testing for release of clinical and commercial products. This includes the ability to interface with multiple groups, the ability to...