Field QA Operations Specialist

2 weeks ago

Ayer, United States Integrated Resources, Inc ( IRI ) Full time

Job Title: Field Specialist QA Operations

Location: Devens, MA

Contract: 12 Months+


This role is 100% Onsite

Work Schedule: Mon - Fri, 07:00 AM - 03:30 PM EST

Holidays required as needed

Job Summary:

The Contractor Field QA Specialist is responsible for quality activities for the Single Use Facility in accordance with client’s policies, standards, procedures, and Global cGMP. Functional responsibilities include ensuring manufacturing compliance with applicable procedures and batch records, providing real time review of manufacturing batch record documentation and logbooks, and working with operations to resolve manufacturing issues. The Contractor Field QA Specialist role is stationed in Devens, MA and reports to the Senior Manager of QA Operations for the Devens SUF.

Job Responsibilities

• Perform QA on the floor activities.

• Ensure manufacturing compliance with applicable procedures and batch records.

• Perform real time review of manufacturing batch records.

• Review manufacturing shop floor documentation.

Education Requirements

• High School Degree required

• Relevant college or university degree preferred.

• Minimum 4 years relevant work experience, with experience in a Quality Assurance role.

Qualifications Required:

• Equivalent combination of education and experience acceptable.

• Must be action-oriented and skilled in decision-making, building relationships, problem solving, conflict management, planning and organizing, resource allocation, coaching others, and analytical thinking.

• Understands continuous improvement and improves efficiency and productivity within the group or project.

• Builds relationships internally within and with cross functional teams.

• Must have sound knowledge and experience in FDA regulated cGMP warehousing, Quality, and compliance environments. Prefer to also have knowledge of GMP Manufacturing operations and processes.

• Directs quality initiatives that accomplish continuous improvement and enhance site quality system efficiencies.

• Routinely recognizes and resolves Quality issues; Informs management of proposed solutions. Seeks management guidance on complex issues.

• Able to recognize conflict and notify management with proposed recommendations for resolution.

• Must possess an independent mindset. Work is self-directed.

• Requires moderate direction to complete more complex tasks; completes routine tasks with little or no supervision.

• Confident in making decisions for non-routine issues.

• Develops and revises procedures.

• Intermediate to advanced ability to interpret results and situations and articulate recommendations for resolution.

• Able to prepare written communications and communicate problems to management with clarity and accuracy.

• Able to effectively multi-task.

• Knowledge of US and global cGMP requirements.

Must have strong authorship and ability to critically review investigations, interpret results and generate technical conclusions consistent with Quality risk management principles.

• Must be skilled in planning and organizing, decision-making, and building relationships.

• Knowledge of quality processes, including material disposition, change control, product complaints, deviations, investigations, and CAPA management.

• Able to effectively multi-task.

• Must have strong authorship and ability to critically review investigations, interpret results and generate technical conclusions consistent with Quality Risk Management principles.

• Must be skilled in planning and organizing, decision-making, and building relationships.

• Knowledge of quality processes, change control, product complaints, deviations, investigations, and CAPA management.

  • Quality Assurance Specialist

    2 weeks ago

    Ayer, United States Dexian Full time

    Job Description: Job Title: Field QA SpecialistLocation: Devens, MA 02141, OnsiteDuration: 12-month contract (Extendable).Hourly Pay: $46/hr to $56/hr on W2 without benefits on W2Schedule: Mon - Fri, 07:00 AM - 03:30 PM ESTHolidays required as needed JOB SUMMARY:We are seeking a Contractor Field QA Specialist for the QA Operations organization at the Single...

  • Quality Assurance Specialist

    2 weeks ago

    Ayer, United States Dexian Full time

    Job Description: Job Title: Field QA SpecialistLocation: Devens, MA 02141, OnsiteDuration: 12-month contract (Extendable).Hourly Pay: $46/hr to $56/hr on W2 without benefits on W2Schedule: Mon - Fri, 07:00 AM - 03:30 PM ESTHolidays required as needed JOB SUMMARY:We are seeking a Contractor Field QA Specialist for the QA Operations organization at the Single...

  • Logistics Operations Specialist

    4 days ago

    Ayer, Massachusetts, United States Aerotek Full time

    Job OverviewWe are seeking a highly skilled Logistics Operations Specialist to join our team at Aerotek. As a key member of our logistics team, you will be responsible for managing the flow of materials and products in our warehouse operations.About the RoleThis is a Contract position based out of Devens, Massachusetts.The pay range for this position is...

  • Operations Coordinator

    5 days ago

    Ayer, Massachusetts, United States Catania Oils Full time

    Job Title: Operations Coordinator - Cycle Counting SpecialistAbout Us: Catania Oils is a rapidly growing, family-owned and operated packager, and processor of edible, plant-based oils. Our facility in Ayer, MA offers a convenient location near major routes 495 and Route 2.Job Overview: We seek a dedicated Operations Coordinator - Cycle Counting Specialist to...

  • IT System Specialist

    1 day ago

    Ayer, United States VS Tech Solutions Full time

    About the job IT System Specialist IT System SpecialistSKILLS: IT system specialist, server, desktop MUST HAVES: Bachelor's degree in Computer Science, Information Technology, cyber security, or related fields. At least 5+ years of experience in a technical engineering role, such as software development, network engineering, technical operations or...

  • Industrial Production Specialist

    6 days ago

    Ayer, Massachusetts, United States Epic Enterprises, Inc Full time

    Job OverviewEpic Enterprises, Inc. is seeking an Industrial Production Specialist to join our team.Salary: $45,000 - $60,000 per year, depending on experience.Key ResponsibilitiesThe successful candidate will be responsible for ensuring the safe and efficient operation of production machines, including startup, shutdown, and preventative maintenance. This...

  • Administrative Support Specialist

    5 days ago

    Ayer, Massachusetts, United States Kenco Logistics Services, LLC Full time

    Job OverviewKenco Logistics Services, LLC is seeking a highly skilled Administrative Support Specialist to join our team. As an Administrative Support Specialist, you will play a vital role in ensuring the smooth operation of our distribution center.About the RoleThe successful candidate will be responsible for providing administrative support to our site...

  • Warehouse Inventory Specialist

    7 days ago

    Ayer, Massachusetts, United States Catania Oils Full time

    Job OverviewCatania Oils, a rapidly expanding family-owned and operated packager and processor of edible, plant-based oils, is seeking a highly skilled Warehouse Inventory Specialist to join its team in Ayer, MA.This exciting role plays a vital part in maintaining high inventory accuracy and integrity. As a Warehouse Inventory Specialist, you will be...

  • Billing & Credentialing Specialist

    1 month ago

    Ayer, United States Care Alliance Health Center Full time

    Description Care Alliance Health Center is a Federally Qualified Health Center and is a leading provider of high-quality medical, dental, behavioral health care, and more. We have been serving the Cleveland community for more than 35 years. About the Job   Care Alliance Health Center is looking for an experienced Credentialing & Billing Specialist  ...

  • Supply Chain Operations Manager

    4 days ago

    Ayer, Massachusetts, United States Kenco Logistics Services, LLC Full time

    About Kenco Logistics Services, LLCKenco Logistics Services, LLC is a leading third-party logistics provider that specializes in supply chain solutions.Job SummaryWe are seeking an experienced Supply Chain Operations Manager to join our team. The successful candidate will be responsible for managing the day-to-day operations of our customers' warehouses and...

  • Automated Production Specialist

    2 days ago

    Ayer, Massachusetts, United States Catania Oils Full time

    Job SummaryWe are seeking a skilled and detail-oriented Automated Production Specialist to join our team at Catania Oils.The successful candidate will be responsible for the proper operation of machine equipment, ensuring high-quality production and meeting company operations equipment effectiveness.Key Responsibilities:Read work orders and order appropriate...

  • Environmental Health

    3 weeks ago

    Ayer, United States Net2Source Inc. Full time

    Net2Source Inc. is an award-winning total workforce solutions company recognized by Staffing Industry Analysts for our accelerated growth of 300% in the last 3 years with over 5500+ employees globally, with over 30+ locations in the US and global operations in 32 countries. We believe in providing staffing solutions to address the current talent gap –...

  • Environmental Health

    3 weeks ago

    Ayer, United States Net2Source Inc. Full time

    Net2Source Inc. is an award-winning total workforce solutions company recognized by Staffing Industry Analysts for our accelerated growth of 300% in the last 3 years with over 5500+ employees globally, with over 30+ locations in the US and global operations in 32 countries. We believe in providing staffing solutions to address the current talent gap –...

  • Medical Foods and Formulas Specialist

    2 days ago

    Ayer, Massachusetts, United States Ajinomoto Cambrooke, Inc. Full time

    About UsAjinomoto Cambrooke, Inc. is a leading provider of nutritional therapies for individuals with rare genetic disorders. Our company was founded by parents who wanted to develop better solutions for their children with Phenylketonuria (PKU). Over the years, we have expanded our focus to include additional therapeutic areas, all centered around improving...

  • Warehouse Operations Specialist

    6 days ago

    Ayer, Massachusetts, United States Catania Oils Full time

    Bulk Materials Handler Job DescriptionCatania Oils is a leading provider of edible oils, seeking a highly motivated Bulk Materials Handler to join our team.Key Responsibilities:Load tank wagons with various cooking oils according to SOPs.Complete shipping paperwork and ensure special customer requirements are met.Communicate with the Manager of the Bulk...

  • Validation Quality Engineer

    4 days ago

    Ayer, United States Integrated Resources, Inc ( IRI ) Full time

    Title: Quality Lead Technical Operations Location: Devens, MADuration: 6 months+Work Schedule: Mon - Fri, First shift (8:30AM - 5PM)Note from manager:Experience: 10 yrs above with Min Bs degree Looking for validation quality engineer + programming or software + automation PM skills /proactive / comm skills/ leadership skills Enterprise background like- sync...

  • Inventory Management Specialist

    6 days ago

    Ayer, Massachusetts, United States Catania Oils Full time

    Company Overview">Catania Oils is a family-owned and operated business that has been around for over 100 years, with four generations at the helm. As a leading packager and processor of edible oils in Ayer, MA, we strive to provide innovative quality products to our customers in an efficient, economic, and environmentally responsible manner.">Job...

  • Inventory Logistics Specialist

    6 days ago

    Ayer, Massachusetts, United States Catania Oils Full time

    At Catania Oils, we're seeking an experienced Inventory Coordinator to join our team. As an Inventory Coordinator, you'll play a critical role in ensuring the accuracy and efficiency of our inventory management processes.About the Role:The successful candidate will be responsible for managing and maintaining accurate inventory records of bulk finished goods...

  • Environmental Health Safety Specialist

    3 weeks ago

    Ayer, United States LanceSoft, Inc. Full time

    Top Skills:Detailed experience with Contractor Safety, Safe Work Permit Program SupportEHS training and Risk/Hazard AssessmentInitiative/autonomyEHS audits/Field Audits and InspectionsEHS program implementationQualifications & ExperienceRequired B.S. Degree in environmental studies, health & safety, science or engineeringMinimum 4 - 6 years of prior EHS...

  • Environmental Health Safety Specialist

    4 weeks ago

    Ayer, United States LanceSoft, Inc. Full time

    Top Skills:Detailed experience with Contractor Safety, Safe Work Permit Program SupportEHS training and Risk/Hazard AssessmentInitiative/autonomyEHS audits/Field Audits and InspectionsEHS program implementationQualifications & ExperienceRequired B.S. Degree in environmental studies, health & safety, science or engineeringMinimum 4 - 6 years of prior EHS...