cGMP Observation/Improvement Associate - 12HR Nights

Job Title: cGMP Observation/Improvement Associate

Department: Quality

Reports To: VP of Quality and Regulatory Affairs

Shift: Friday - Sunday 6pm - 6am

PRIMARY PURPOSE or JOB SUMMARY:

Legacy Pharma Solutions is a leading organization committed to delivering high quality products that meet or exceed regulatory standards. We are seeking dynamic individuals to join our Cross Functional cGMP FDA Regulated Observation Team. This team plays a critical role in ensuring compliance with current Good Manufacturing Practices (cGMP) and FDA regulations.

As a member of the Cross-Functional cGMP FDA Regulated Observation Team, you will be responsible for conducting thorough inspections and observations to assess the compliance of our packaging processes with cGMP and FDA regulations. This role requires a multidisciplinary approach, collaborating with various departments to identify, report, and address potential compliance issues.

Key Responsibilities:

1. Conduct Regulatory Observations:
   1. Perform regular inspections of Packaging processes and facilities to ensure compliance with cGMP and FDA regulations and Legacy procedures.
   2. Document and report observations, deviations, and potential areas of improvement.
2. Cross-Functional Collaboration:
   1. Collaborate with teams across different departments, including production, quality assurance, quality control, regulatory affairs, and maintenance.
   2. Foster effective communication to address compliance issues promptly.
3. Data Analysis:
   1. Analyze data related to manufacturing processes and product quality to identify trends or potential compliance concerns.
   2. Work with relevant teams to implement corrective and preventive actions.
4. Training and Education:
   1. Stay informed about updates to cGMP and FDA regulations.
   2. Provide training and education to team members and other stakeholders on compliance best practices.
5. Continuous Improvement:
   1. Participate in cross-functional teams to drive continuous improvement initiatives.
   2. Propose and implement process enhancements to ensure sustained compliance.

ACCOUNTABILITY:

The cGMP Improvement Team member shall be held accountable for the compliance, accuracy and timeliness of responsibilities and work assigned.

SUPERVISORY RESPONSIBILITIES:

None

• High School diploma or GED certificate required
• Able to stand and walk for 8+ hours
• Thorough understanding of the Code of Federal Regulations 21CFR Part 210, Part 211 and Part 11.
• Familiarity with Microsoft Office (Word, Excel, Project, Power Point, Outlook).
• Excellent communication and interpersonal skills.
• Detail oriented with a commitment to accuracy and thorough documentation.
• Ability to work collaboratively in a cross functional team environment.
• Strong Understanding of LPS's processes and procedures.
• Flexibility to work any shift, as assigned by management.
• Flexibility to work weekends and holidays, if required by business needs

WORKING CONDITIONS:

Production Environment/Warehouse

ADDITIONAL COMMENTS:

• Must be well versed in organizational leadership, technical writing and communications.
• Must be able to exercise sound judgment and discretion during all functions as it relates to Legacy Pharma Solutions.
• Excellent problem-solving skills with a strong attention to detail.
• Highly organized, with the ability to manage priorities and coordinate multiple projects simultaneously ensuring deliverable timelines are consistently met.