In-Process Quality Coordinator (2nd Shift)

Job Summary

The In-Process Quality Coordinator ensures consistent product quality by providing QA support for manufacturing activities on the production floor. This includes monitoring product quality, inspecting product-contact equipment, analyzing purified water, and testing in-process product during manufacturing within a cGMP-regulated pharmaceutical manufacturing environment.

Duties And Responsibilities

• Follows all policies, procedures, SOPs, cGMP, Work Instructions, and supervisor instructions.
• Performs verification of manufacturing operations.
• Collections samples and performs in-process testing (pH, dissolved oxygen, titrations, etc.) and assay calculations for compounding operations.
• Performs batch calculations and QS verifications.
• Collections samples and performs TOC analysis on clean equipment.
• Performs daily checks on the TOC levels of the purified water system.
• Collections and maintains data for quality reporting.
• Supports the development and revision of SOPs, Work Instructions (WIs), and related quality documents.
• Maintains up-to-date knowledge of cGMPs, regulatory requirements, and company quality policies.
• Promotes cGMP compliance in an FDA/DEA regulated pharmaceutical manufacturing environment.
• Participates in continuous improvement activities to enhance product quality and operations efficiency.
• Accountable for the compliance, accuracy and timeliness of responsibilities and work assigned.
• Accountable for personal honesty, integrity, good attendance, and strong work ethic.
• Maintain skill set by remaining current in industry standards and best practices through continuous training.
• Provides on-the-job training to new team members as assigned.
• Perform any other related duties as required or assigned.

Required Skills/Abilities

• Communication Skills – Excellent communication skills, both verbal and written.
• Mathematical Skills – Ability to calculate figures and amounts such as discounts, interest, commissions, proportions, percentages, area, circumference, and volume.
• Critical Thinking Skills – Ability to utilize common sense understanding to carry out written, oral or diagrammed instructions. Ability to deal with problems involving several known variables in situations of a routine nature.
• Advanced critical thinking and analytical reasoning skills – able to evaluate data, identify trends, and make quality-based decisions.
• Strong attention to detail, accuracy, and documentation discipline.
• Able to manage multiple priorities and work effectively under minimal supervision.
• Strong interpersonal skills with the ability to work collaboratively across departments.
• Self-motivated, dependable, and demonstrates high ethical and professional standards.

Education And Experience

• High school diploma or GED required; associate degree in a scientific or technical discipline preferred.
• Minimum 2 years of Quality Assurance or Quality Control experience in a pharmaceutical or regulated manufacturing environment required.
• Demonstrated understanding of FDA/DEA regulations, cGMP compliance, and documentation practices.
• Strong mathematical aptitude and ability to perform precise calculations and data entry.
• Proficiency with Microsoft Office (Word, Excel, Outlook).