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40 Repligen Quality Control Analyst Jobs Hiring Near You

Repligen

Consolidations Manager

Waltham, MA · On-site

$94.34K - $144.63K/yr

Make a global impact-join Repligen. We're united by a mission to inspire advances in bioprocessing ... Securities and Exchange Commission, whilemaintaininga strong internal control environmentin ...

Repligen

$156.07K - $239.31K/yr

Make a global impact-join Repligen.We're united by a mission to inspire advances in bioprocessing ... AI, automation, and analytics to improve quality, efficiency, and innovation.Support system ...

Repligen

$143.10K - $200K/yr

Make a global impact-join Repligen.We're united by a mission to inspire advances in bioprocessing ... analysis Mature and enforce ITIL processes (incident, problem, and change management) using ...

Repligen

$124.60K - $150K/yr

Make a global impact-join Repligen.We're united by a mission to inspire advances in bioprocessing ... Analyze and respond to technical questions related to product use and performance, product quality ...

Repligen

Director, Engineering (Filtration)

Marlborough, MA · On-site

$165K - $250K/yr

Own process characterization, validation, and control strategies across manufacturing operations ... Engineering project delivery (schedule, cost, and quality) What Repligen Offers Our mission is to ...

Repligen Corporation

Consolidations Manager

Waltham, MA · On-site

$94.34K - $144.63K/yr

Make a global impact-join Repligen. We're united by a mission to inspire advances in bioprocessing ... Securities and Exchange Commission, while maintaining a strong internal control environment in ...

Repligen

$165K - $250K/yr

EngineeringOwn process characterization, validation, and control strategies across manufacturing ... quality)What Repligen OffersOur mission is to inspire advances in bioprocessing as a trusted ...

Repligen

$75K - $105K/yr

Design consumable components compatible with Repligen and customer-specified hardware, ensuring ... Demonstrated organizational, analytical, and problem-solving skills, with strong attention to ...

Repligen

Applications Engineer I (Remote)

Hopkinton, MA · On-site +1

$75K - $105K/yr

Design consumable components compatible with Repligen and customerspecified hardware, ensuring ... Demonstrated organizational, analytical, and problemsolving skills, with strong attention to detail ...

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RepliGen Jobs Information

What are the key skills and qualifications needed to thrive as a Quality Control Analyst, and why are they important?

To thrive as a Quality Control Analyst, you need a solid understanding of quality assurance principles, data analysis, and laboratory or manufacturing processes, often supported by a degree in a related scientific or technical field. Familiarity with tools such as LIMS (Laboratory Information Management Systems), statistical software, and regulatory standards (like GMP or ISO) is typically required. Attention to detail, problem-solving abilities, and strong communication skills help analysts identify issues and collaborate effectively with team members. These skills ensure products or processes consistently meet quality standards, safeguarding consumer safety and organizational reputation.

What are some common challenges faced by Quality Control Analysts, and how can they be effectively managed?

Quality Control Analysts often encounter challenges such as tight production deadlines, variability in sample quality, and adapting to frequent changes in testing protocols or regulatory standards. Managing these challenges involves strong organizational skills, proactive communication with production and laboratory teams, and staying current with industry regulations. Developing efficient documentation practices and using digital tools for data management can also help maintain accuracy and streamline workflow, ultimately supporting consistent product quality.

What does a Quality Control Analyst do?

A Quality Control Analyst is responsible for testing and inspecting products or processes to ensure they meet established quality standards. They analyze samples, identify defects or inconsistencies, and document their findings to help maintain product quality and safety. Their work helps organizations comply with regulations and deliver reliable products to customers. Quality Control Analysts often work in industries such as pharmaceuticals, manufacturing, and food production.

What is the difference between Quality Control Analyst vs Quality Assurance Specialist?

AspectQuality Control AnalystQuality Assurance Specialist
CertificationsOften requires certifications like ASQ CQE or ISO auditorSimilar certifications, with focus on process audits
Work EnvironmentLaboratory, manufacturing, or production settingsOffice-based, process review, and compliance environments
Primary FocusTesting products, identifying defects, ensuring quality standardsDeveloping and maintaining quality systems, preventing defects
Industry UsageManufacturing, pharmaceuticals, food productionManufacturing, software, healthcare industries

While both roles aim to ensure product quality, the Quality Control Analyst primarily tests and inspects products to identify defects, whereas the Quality Assurance Specialist focuses on creating and improving processes to prevent defects. Both roles often require similar certifications and work in related environments, but their core responsibilities differ in focus and approach.

What other companies are hiring for Quality Control Analyst jobs?
What are the most popular jobs at Repligen?
What are the most popular categories at Repligen?
Infographic showing various Quality Control Analyst job openings at Repligen in the United States as of May 2026, with employment types broken down into 100% Full Time. Highlights an 90% Physical, 5% Hybrid, and 5% Remote job distribution.
Plastics Process Engineer II

Plastics Process Engineer II

Repligen Corporation

Clifton, NY • On-site

$85.29K - $110.37K/yr

Full-time

Medical, Dental, Vision, Retirement, PTO

Posted 23 days ago

Repligen rating

8.7

Company rating: 8.7 out of 10

Based on 9 frontline employees who took The Breakroom Quiz

Job description

Make a global impact-join Repligen.
We're united by a mission to inspire advances in bioprocessing as a preferred partner in the production of biologic drugs that improve human health worldwide. No matter your role or background, at Repligen, you will play a key part in shaping some of the most innovative and life-changing therapies in the world. We foster a culture of purpose, collaboration, and shared success-where every voice matters and every contribution drives progress. Join us!
The Plastics Injection Molding Process Engineer II is responsible for developing, optimizing, and maintaining robust molding processes that ensure consistent product quality, operational efficiency, and safety compliance. This mid-level role serves as a technical leader in process development and troubleshooting, supporting production, tooling, and design teams to improve yields, reduce downtime, and enhance overall manufacturing performance.
This role is expected to model our Leadership Behaviors-Integrity & Compliance, Customer Focus, Collaboration, Courage, Team Empowerment, and Accountability & Results-in all aspects of work.
Responsibilities
  • Own assigned molding processes and ensure adherence to validated parameters
  • Apply scientific molding principles to establish and maintain robust process windows
  • Monitor process performance using SPC tools; analyze trends to reduce scrap and downtime
  • Support cycle time reduction, yield improvement, and OEE optimization projects
  • Lead troubleshooting for common molding issues (short shots, flash, splay, burns) and implement corrective actions
  • Collaborate with Maintenance and Tooling teams to resolve equipment and mold-related issues
  • Provide technical guidance to operators and technicians on setup and process adjustments
  • Author and execute IQ/OQ/PQ protocols for molds and equipment under supervision of senior engineers
  • Maintain accurate process documentation, setup sheets, and validation reports per cGMP and ISO 9001 requirements
  • Participate in change control activities for process improvements and equipment upgrades
  • Drive small-scale improvement projects using Lean/Six Sigma methodologies.
  • Support kaizen events and implement standard work for mold changes and machine setups
  • Assist in automation integration (robots, vision systems, CMM) and auxiliary equipment optimization
  • Ensure compliance with cleanroom protocols (ISO 14644) and contamination control procedures
  • Participate in CAPA investigations and root cause analysis for process deviations
  • Maintain adherence to regulatory standards for biopharmaceutical components (USP <87>/<88>, ISO 9001)

Qualifications
  • BS in Plastics/Polymer, Mechanical, Chemical, or Manufacturing Engineering (or equivalent)
  • 3-7 years of injection molding experience in a regulated environment
  • Hands-on experience with Arburg injection molding machines and auxiliary equipment
  • Working knowledge of Scientific Molding, SPC, and basic DOE principles
  • Strong documentation and communication skills

Our mission is to inspire advances in bioprocessing as a trusted partner in the production of biologic drugs that improve human health worldwide. Focused on cost and process efficiencies, we deliver innovative technologies and solutions that help set new standards in bioprocessing. The estimated salary range for this role, based in the United States of America is $85,289-110,374. Compensation decisions are dependent on several factors including, but not limited to an individual's qualifications, location, internal equity, and alignment with market data. Additionally, employees are eligible to participate in one of our variable cash programs (bonus or commission) and eligible roles may receive equity as part of the compensation package. We offer a wide range of benefits such as paid time off, health/dental/vision, retirement benefits and flexible spending accounts. All compensation and benefits information will be confirmed in writing at the time of offer.

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