Job description

DUTIES AND RESPONSIBILITIES:

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

2. Establish a process to manage and maintain current the Internal audit program, assist with issuance of the 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 effectiveness checks.

4. Track the review completion 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. Track completion of Process Validation, Cleaning and Sanitization activities upon request.

6. Ensure compliance with Sample and Document Retention program requirements.

7. Maintain the training program current by ensuring compliance with the training matrix requirements and ensure employee’s training requirement are up to date. This would include adherence to all annual training (initial and refresher) as well SOP review cycles.

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

9. Identify, communicate and execute process improvements.

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

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

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

13. Perform additional assignments and responsibilities to ensure compliance with current Federal, States and Local regulatory requirements, ISO standards, OSHA requirements. Such tasks include and not limiting to product listing with the FDA and other marketing regions, facility registrations etc. as appropriate by Department’s Management.

QUALIFICATIONS:

· Associate Degree in Scientific Related Field.

· Minimum 2 to 3 years in quality assurance and regulatory compliance experience.

· Experience in the operations of Personal Care industry and/or Third Party Contract Manufacturing facility.

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

· knowledgeable 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

Experience level:

• 2 years

Schedule:

• 8 hour shift
• Monday to Friday

Work setting:

• In-person

Ability to commute/relocate:

• Carteret, NJ 07008: Reliably commute or planning to relocate before starting work (Required)

Work Location: In person

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