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Quality Assurance Specialist - Complaints NOT REMOTE IN GA
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- Full-time
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Quality Assurance Specialist - Complaints NOT REMOTE IN GA

Pharma Tech Services LLC
Royston, GA

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Job Details

Full-time

Qualifications

Content creation for technical audiences
Investigations regulatory compliance
Drug regulation
Technical writing experience within manufacturing
Internal investigations
FDA regulations
Pharmaceutical manufacturing facility experience

Full Job Description

Description:

Receive, log, and track product complaints in compliance with customer quality agreements, internal procedures, and regulatory requirements.
Assist in evaluating complaints for potential quality, safety, or regulatory impact.
Support investigations into product complaints by gathering data, reviewing batch records, and coordinating with Manufacturing, Quality Control, and other departments.
Document complaint investigations in accordance with GDP and ALCOA+ principles, ensuring accuracy and completeness.
Escalate critical or serious complaints to QA management as appropriate.
Support trending and analysis of complaint data; assist in identifying potential issues and recommending improvements.
Participate in preparation for regulatory inspections, customer audits, and internal audits related to complaint management.
Assist in revising or drafting SOPs, work instructions, and QA procedures related to complaint handling.
Collaborate with QA and cross-functional colleagues to ensure timely closure of complaint investigations.
Initiate SCARs, when deemed necessary, for non-conforming materials discovered in the manufacturing process.
Coordinate cross-functionally with Procurement, Operations, and Quality teams to drive closure of SCARs and ensure supplier accountability.
Maintain product retention samples in clean and organized Retain Room(s) that are compliant with all internal procedures and regulatory requirements.
Discard product retention samples, as needed, with appropriate documentation following all regulatory requirements.
Maintain audit readiness and compliance with FDA, EMA, ICH, and other regulatory expectations.
All other activities commensurate with the role, as required

Requirements:

Minimum Qualifications

Bachelor’s degree in a relevant scientific discipline (e.g., Chemistry, Biology, Microbiology, Pharmaceutical Sciences) or equivalent combination of education and experience
Minimum of 2–4 years of experience in Quality Assurance within a GMP-regulated environment (pharmaceutical preferred)
Demonstrated experience handling product complaints, investigations, or deviations
Working knowledge of 21 CFR Parts 210 and 211 and applicable FDA guidance
Proficiency in quality systems (e.g., TrackWise, MasterControl, or equivalent electronic QMS)
Strong technical writing and documentation skills

Core Competencies

Thorough understanding of Good Manufacturing Practices (GMP) and data integrity principles (ALCOA+)
Ability to conduct root cause analysis (e.g., 5 Whys, Fishbone, CAPA methodologies)
Strong attention to detail with the ability to identify trends and systemic issues
Effective cross-functional communication (Operations, QC, Regulatory Affairs, Customer Service)
Ability to manage multiple investigations simultaneously while meeting regulatory timelines
Critical thinking and decision-making in a regulated environment

Regulatory & Compliance Requirements

Ensure all complaint handling activities comply with 21 CFR Part 211, specifically Subpart J – Records and Reports (Complaint Files)
Maintain complaint files in accordance with FDA data integrity expectations and internal SOPs
Support FDA inspections, audits, and regulatory inquiries related to complaint handling
Ensure timely reporting of adverse events, product quality complaints, and potential reportable events (e.g., Field Alerts, if applicable)

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Quality Assurance Specialist - Complaints NOT REMOTE IN GA

QAQC Lab Technician

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