QA Assistant

The QA Assistant at Cosco International Inc. supports the daily operations of the Quality Assurance Department under GMP, ISO 9001 / ISO 22716, Organic, and FDA Medical Device regulatory frameworks.

This position assists with document control, batch record review, COA and SDS generation, training documentation, and audit readiness. The QA Assistant ensures that all quality documentation is accurate, complete, and compliant with internal policies and regulatory standards. The role also provides administrative and operational support to the QA Manager and Regulatory/QMS team to maintain audit-readiness and continuous compliance.

Core Responsibilities

1. Documentation Control & Record Management

· Assist in maintaining the Quality Management System (QMS) documentation under the guidance of the QA Manager and QMS Director.

· File, organize, and maintain all controlled documents including:

o Batch records

o Test reports

o Certificates of Analysis (COAs)

o Safety Data Sheets (SDSs)

o SOPs, training records, and validation reports

· Track document revisions and ensure obsolete versions are removed from circulation.

· Support the issuance and retrieval of controlled documents for QA, QC, and Regulatory use.

2. Batch Record Review & COA Preparation

· Assist in the review of batch production records to ensure completeness, accuracy, and compliance before QA approval.

· Verify raw material lot numbers, yield calculations, and production sign-offs.

· Ensure COAs match analytical results and include all required customer and regulatory information.

· Support QA in the preparation and verification of Safety Data Sheets (SDSs) for product registration and distribution.

3. QA Data Entry & Reporting

· Enter QA-related data into digital systems, including ERP, QMS, and tracking logs.

· Maintain training records, calibration logs, and deviation/CAPA databases.

· Assist the QA Manager with compiling reports and metrics such as:

o Non-conformances

o Deviation summaries

o CAPA status updates

o Product release trends

· Support preparation of monthly QA department summaries for management review.

4. GMP / ISO / Organic / Medical Device Compliance

· Assist the QA and Regulatory teams in maintaining compliance with:

o ISO 9001 / ISO 22716 (Cosmetic GMP)

o FDA 21 CFR 210/211 and 820 (Medical Device QMSR)

o USDA Organic Certification

· Ensure QA documentation is audit-ready and meets all retention and traceability requirements.

· Support QA during customer, certification, and FDA inspections by preparing requested documentation.

5. Training & Good Laboratory Practice (GLP) Support

· Maintain QA staff training records and schedules.

· Support the QA Manager and Regulatory Affairs in organizing training sessions for QA/QC/Production employees on:

o GMP documentation

o Good Laboratory Practices (GLP)

o Company SOPs and data integrity

· Verify attendance and update the training matrix after each session.

· Ensure employees have access to current SOPs and quality policies.

6. Cross-Functional Support

· Work closely with:

o QC Laboratory – for test data verification and COA generation.

o Production – for batch record accuracy and sample reconciliation.

o Regulatory Affairs – for product registration, labeling documentation, and change control.

o R&D – for formulation documentation and sample traceability.

· Help coordinate sample retention and labeling in line with QA and QC procedures.

· Provide administrative support during audits and compliance projects.

7. Continuous Improvement

· Identify areas for improvement in QA documentation processes and suggest updates to the QA Manager.

· Participate in the review and revision of SOPs related to documentation and batch review.

· Support QA projects to digitize and streamline manual documentation processes.

Key Performance Indicators (KPIs)

· Document Control Accuracy: 100%

· COA/SDS Error Rate: < 1%

· Batch Record Review Turnaround: ≤ 48 hours after receipt

· Training Record Completion: 100%

· Audit Readiness: 100%

· On-Time Data Entry / Reporting: 100%

Qualifications

· Associate or Bachelor’s degree in Chemistry, Quality Management, Regulatory Affairs, or related field.

· Minimum 1-2 years of experience in a regulated manufacturing environment (cosmetics, OTC, medical device, or pharmaceutical).

· Basic understanding of GMP, ISO, FDA, and Organic certification standards.

· Strong organizational, data entry, and documentation skills.

· Proficiency in Microsoft Office (Word, Excel, Outlook) and experience with ERP/QMS systems preferred.

· Excellent attention to detail and communication skills.

· Ability to work collaboratively with QA, QC, and Regulatory teams.

Pay: $18.00 - $25.00 per hour

Benefits:

• 401(k) matching
• Health insurance
• Paid time off
• Vision insurance

Work Location: In person

Salary : $18 - $25