Jr Quality Engineer

at  PL Developments LLC

JOB QUALIFICATIONS:

• Bachelor’s Degree in Science, Engineering or related field from an accredited college or university
• 5+ years related experience preferably in a quality assurance environment; or, an equivalent combination of education and/or experience
• Must be an effective communicator and understand written procedures
• Very knowledgeable in cGMPs, FDA regulations and guidance and other regulatory requirements in a regulated manufacturing environment
• Investigations to determine cause corrective action and prevention planning.
• Attention to detail
• Excellent interpersonal and communication skills
• Ability to follow routine verbal or written instructions
• Able to work under pressure and meet deadlines
• Computer literate
• Able to work with minimal supervision

EXPERIENCE

Required

• cGMPs, FDA regulations and guidance and other regulatory requirements in a regulated manufacturing environment
• 5 - 8 years: Experience preferably in a quality assurance environment

EDUCATION

Required

• Bachelors or better

• Analyzes data from production and laboratories, reports deviations (Manufacturing, Laboratory) and consults with other departments to identify recurrent problems, and coordinates resolution of complex quality issues.
• Researches and recommends improvements in production.
• Oversees Quality Systems related to the Product/ Technology Transfer Process.
• Complies with all Company policies and procedures, including safety rules and regulations.
• Current Good Manufacturing Practices (cGMP), Food and Drug Administration (FDA) and other regulatory requirements in a regulated manufacturing environment.
• Supports the training department in assessing Quality training requirements and revising them as needed. Provides training to manufacturing operators in MBR’s.
• Supports the Computer systems Validation by reviewing and approving related Qualification/Validation Protocols and Reports.
• Support site deviation system as site system administration.
• Create and review new production and packaging records.
• Review and work together with production department in the preparation and writing of deviations/investigations.
• Support the QA department compiling data, reviewing and approving APR’s for OTC products.