In-Process Quality Coordinator

PAI Holdings LLC • Greenville, SC

2d • Onsite

About The Position

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. This full-time position provides intermediate-level Quality Assurance support across manufacturing operations. The In-Process Quality Coordinator applies critical thinking, analytical reasoning, and sound judgment to evaluate data, identify deviations, and ensure compliance with internal procedures and regulatory requirements (FDA, DEA).

Requirements

• Excellent communication skills, both verbal and written.
• Ability to read and understand simple instructions, short correspondence, notes, letters and memos; Ability to write simple correspondence.
• Ability to calculate figures and amounts such as discounts, interest, commissions, proportions, percentages, area, circumference, and volume.
• Ability to apply concepts such as fractions, ratios, and proportions to practical situations.
• 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.
• Ability 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.
• High school diploma or GED required.
• 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).

Nice To Haves

• associate degree in a scientific or technical discipline preferred.

Responsibilities

• Follows all policies, procedures, SOPs, cGMP, Work Instructions, and supervisor instructions.
• Perform verification of manufacturing operations.
• Collects samples and performs in-process testing (pH, dissolved oxygen, titrations, etc.) and assay calculations for compounding operations.
• Perform batch calculations and QS verifications.
• Collects samples and performs TOC analysis on clean equipment.
• Perform daily checks on the TOC levels of the purified water system.
• Collects and maintains data for quality reporting.
• Support the development and revision of SOPs, Work Instructions (WIs), and related quality documents.
• Maintain up-to-date knowledge of cGMPs, regulatory requirements, and company quality policies. Promote cGMP compliance in an FDA/DEA regulated pharmaceutical manufacturing environment.
• Participate in continuous improvement activities to enhance product quality and operations efficiency.
• Accountable for the compliance, accuracy and timeliness of responsibilities and work assigned. Also, 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.
• Provide on-the-job training to new team members as assigned.
• Perform any other related duties as required or assigned.

Benefits

• PAI is an Equal Opportunity Employer.
• In compliance with the Americans with Disabilities Act, PAI will provide reasonable accommodations to qualified individuals with disabilities and encourages both prospective and current employees to discuss potential accommodations with the employer.
• PAI uses E-Verify.
• PAI Pharma is a nicotine-free campus, meaning the use of nicotine products—including cigarettes, vaping, chewing tobacco, and any other nicotine-containing substances—is strictly prohibited on company property.
• All employees should be able to complete their full shift without the need to use nicotine.
• By joining PAI Pharma, you agree to adhere to our nicotine-free workplace policy, which supports a healthier environment for all employees.
• EEO Employer / Veteran / Disabled

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: High school or GED