Quality Systems Manager

Job Description

Work Schedule: Monday-Friday 9am-5:30pm

JOB QUALIFICATIONS:

• Bachelor's degree in Scientific or Technical Field
• Experience with Microsoft Office, specifically Word, Excel, Powerpoint
• Strong understanding of the principles and application of cGMP guidelines and regulations in 21 CFR Parts 11, 210, 211
• 3+ years in leadership role
• Familiar with requirements of 21 CFR part 11 for data integrity
• Exceptional verbal and written communication skills including technical writing is required.
• Excellent planning, time-management, problem-solving, and organizational skills required.
• Experience in Enterprise Resource Planning (ERP) software, Oracle system preferred.
• Experience in Quality Management System software, such as Agile or TrackWise
• Ability to think strategically and manage multiple projects and tasks
• Ability to train people (public speaking)
• Spanish speaking is a plus
  
  

POSITION RESPONSIBILITIES:

• Responsible for Revise and create new Standard Operating Procedures, Work Instructions and other controlled documents as needed
• Create and present corporate GMP training for all PLD sites
• Oversee quality systems team, including corporate training, document control and change control functions
• Support regulatory, third party and customer audits for all PLD sites
• Support systems validation team on project needs
• Lead Internal Quality projects for compliance and continuous improvement
• Interface with all departments on changes, projects, and training
• Support Corporate quality training for all PLD sites as needed, including creating training content
• Support Neww Hire cGMP training as needed
• Work with Document Control personnel to proofread new and revised documents in Agile
• Enter data into validated training system
• Backup for change analyst responsibilities for document, protocol and general CRN workflows
• Review and approve change controls for Quality related to job functions
• Report on Corporate Quality Metrics
• Support Sr. Director of Quality with any other needs
  
  

Starting Salary: $75,000

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Company Description

PL Developments is an over-the-counter pharmaceutical manufacturing and packaging company, headquartered in New York. We have an excellent work environment, truly invest in our people, and believe in great work/life balance. We offer a comprehensive benefits package.

PLD participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.

PL Developments is an over-the-counter pharmaceutical manufacturing and packaging company, headquartered in New York. We have an excellent work environment, truly invest in our people, and believe in great work/life balance. We offer a comprehensive benefits package. PLD participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.