Job description

SUMMARY: The Quality Assurance Specialist Authors, maintains and distributes all documents necessary to define product configuration and control manufacturing processes. Perform Document Review and releases of Products (Cosmetic and OTC) for commercialization. Ensures conformance with customer requirements; develops and maintains a comprehensive filing system and computer database for all retention of documents in the document control center. Manages the operation of the document control to ensure all users have the latest revision of appropriate documentation promptly.

DUTIES AND RESPONSIBILITIES:

1. Author, Track and Monitor timely processing of Control documents such as Change Management, CAPA, Investigation, Annual Drug Product Reviews (ADPR), Standard Operating Procedures (SOP) and maintain current the corresponding database.

2. Manage the Internal audit program, issue audit report and track completion of audit responses and CAPA.

3. Assist with external Audits, track completion of the audit observations’ corrective action and preventive action (CAPA) and monitor their effectiveness.

4. Manage the reviews and approval of control documents such as Master Product Formula, Internal and Customer’s specifications, Raw Material Codes and Component Code revision, Filling and Packaging (F&A).

5. Assist with Process Validation, Cleaning and Sanitization activities upon request.

6. Ensure compliance with Sample and Document Retention program.

7. Manage and maintain compliance with the facilities equipment logbooks. Perform Shop floor activities to support the manufacturing and production activities.

8. Re-enforce current Good Documentation and Manufacturing Practices and other FDA regulations and applicable Guidelines.

9. Perform OTC Batch Record Reviews, drive timely correction of deficiencies found to support timely releases of products.

10. Review quality issues with products, determine level of severity, perform trouble shooting or other investigative work to support report creation and final disposition.

11. Identify, communicate and execute process improvements.

12. Participate in various cross-functional project teams, interactions with Technical operations and other key partners both internal and external to the company.

13. Foster a team environment and team building for the improvement of processes and enhancement of productivity to align with key business objectives.

14. Develop and maintain a comprehensive filing system and computer database for all retention of documents.

15. Perform additional assignments and responsibilities as determined by Department’s Management.

QUALIFICATIONS:

· Bachelor Degree in Scientific Related Field.

· Minimum 2 to 3 years in quality assurance, compliance experience, Operations in the Personal Care industry and/or Third Party Contract Manufacturing facility.

· Knowledge with manufacturing quality (manufacturing, packaging, facilities, Quality Management systems, automation, validation, etc.) preferred.

· Experience in Quality Assurance, Investigation & CAPA, Change Control, Document Control, and Training Systems.

· Continuous improvement mindset.

· Strong interpersonal skills and the ability to communicate clearly in an engaging manner with colleagues of various levels of experience and management.

· Must have great organizational skill.

· Ability to manage multiple projects or customers in a fast-paced environment.

· Strong computer skills including Microsoft Office Suite proficiency.

Job Type: Full-time

Benefits:

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

Schedule:

• 8 hour shift

Work Location: One location

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