In-Process Quality Coordinator

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. 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).

Supervisory Responsibilities:

None

Duties and Responsibilities:

1. Follows all policies, procedures, SOPs, cGMP, Work Instructions, and supervisor instructions.
2. Perform verification of manufacturing operations.
3. Collects samples and performs in-process testing (pH, dissolved oxygen, titrations, etc.) and assay calculations for compounding operations.
4. Perform batch calculations and QS verifications.
5. Collects samples and performs TOC analysis on clean equipment.
6. Perform daily checks on the TOC levels of the purified water system.
7. Collects and maintains data for quality reporting.
8. Support the development and revision of SOPs, Work Instructions (WIs), and related quality documents.
9. Maintain up-to-date knowledge of cGMPs, regulatory requirements, and company quality policies. Promote cGMP compliance in an FDA/DEA regulated pharmaceutical manufacturing environment.
10. Participate in continuous improvement activities to enhance product quality and operations efficiency.
11. 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.
12. Provide on-the-job training to new team members as assigned.
13. Perform any other related duties as required or assigned.

Required Skills/Abilities:

To perform this job successfully, an individual must be able to perform the duties and responsibilities satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required.

• Communication Skills - 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.
• Mathematical Skills - 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.
• 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.
• 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.

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).

Physical Requirements/ Working Conditions:

• Regularly required to stand, walk, sit, talk, and hear.
• Occasionally required to climb, balance, stoop, kneel, crouch, or crawl.
• Must be able to lift up to 50 lbs.
• Visual requirements include the ability to see up close or at a distance, colors, and depth perception. Safety glasses are required.
• Work is performed in both office and manufacturing environments with exposure to moving mechanical parts and occasional contact with chemicals.
• Must comply with gowning and cleanroom entry requirements.
• Moderate noise level typical of manufacturing environments.

To perform this job successfully, an individual must be able to perform the essential job functions satisfactorily. 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