Primary responsibility is to complete the review and approval of Laboratory and Computer System Validation records, documents or other assignments in a timely manner while maintaining compliance with cGMP requirements, FDA, OSHA, EPA, and DEA. Also, lead a Quality Assurance group to support laboratory operations in terms of Sample management, Technical Review, document management and management of stability program.

Responsibilities;

• Design, implement and manage the installation and use of Master Control to handle the electronic documentation of Market Complaint, Deviation, OOS, Outliers, Root Cause Investigation, CAPAs, Recall, Change Controls, SOP and training.
• Chair the Investigations review Board (IRB) meetings, issue minutes and follow up on corrective and preventative actions.
• Manage and trend the deviation process while ensuring that a thorough investigation report is completed in a timely manner using proven root cause analysis tools.
• Manage the review, tracking, GMP compliance and approval of Change Controls for Production Processes, Facilities and Equipment.
• Manage all CAPA commitments to ensure timely completion of the outlined tasks and effectiveness.
• Manage the Customer Complaint system for both product and adverse event complaints; ensuring investigations are performed on time and any notifications meet regulatory reporting requirements (i.e. Field Alert Reports (FARs), 3 day and 15 day alerts, etc.)

Requirements

BS or MS degree in chemistry or related field preferred

• Working knowledge of laboratory Instrument like HPLC, UPLC, GC Dissolution, AA, UV spectrophotometer Aptitude for application of analyticalmethods
• Proficiently skilled in laboratory techniques Ability to work independently
• Takes initiative on assignments and day to day responsibilities
• Keen observational skills and attention to detail
• Proficient in personal computers
• Excellent interpersonal and communication skills Organizational and planning skill
• Continuous working knowledge of applicable cGMP guidelines Continuous working knowledge of applicable DEA regulations

Benefits

401(k) with matching

Health, Vision, Dental Insurance

Childcare Scholarship

Tuition Reimbursement

Bonus Pay + Merit Increases

Paid Time Off

Flexible Holidays