(QA-QC) Inspector II

Mindlance; Worcester (MA); On-site; USD 40,000 - 80,000; Full time

Job summary

An established industry player is seeking an Associate Data Reviewer to join their dynamic team in a fast-paced GMP environment. This role focuses on critical areas such as raw material and environmental monitoring, ensuring compliance with GMP standards while managing data review tasks. The ideal candidate will possess a Bachelor's Degree or a High School Diploma with significant experience in manufacturing or quality assurance within the pharmaceutical sector. Join a collaborative team dedicated to maintaining high-quality standards and fostering a positive work atmosphere.

Qualifications

• Bachelor's Degree or High School Diploma with 3-5+ years in QA/QC.
• Experience in the pharmaceutical or biologics industry is preferred.

Responsibilities

• Archiving data in the RIMS system and performing lab test data reviews.
• Maintaining GMP standards and supporting administrative tasks.

Skills

Data Review

Data Mining

GMP Standards

Time Management

Education

Bachelor's Degree

High School Diploma with Experience

Tools

RIMS System

Job description

The Associate Data Reviewer supports the data review team within a fast-paced GMP environment, focusing on areas such as raw material, environmental monitoring, in-process, final bulk, stability, or validation. The coordinator is responsible for reviewing assays, data mining projects, and archiving data. They work under supervision but are expected to manage their time efficiently to complete duties promptly.

Responsibilities

1. Archiving data in the RIMS system.
2. Performing routine review of lab test data, including on-the-floor and off-the-floor reviews for low-complexity test methods.
3. Maintaining a safe work environment in accordance with procedural requirements.
4. Implementing and maintaining GMP standards for laboratory records, procedures, and systems.
5. Completing assigned tasks responsibly and collaborating to foster a positive work atmosphere.
6. Supporting administrative tasks such as logbook management and data filing.
7. Participating in employee training, focusing on demonstration rather than management of training delivery.

Qualifications

Bachelor’s Degree OR High School Diploma with 3-5+ years of experience in manufacturing, QA, or QC within the pharmaceutical or biologics industry.

EEO Statement

Mindlance is an Equal Opportunity Employer and does not discriminate based on minority, gender, disability, religion, LGBTQI status, age, or veteran status.