Quality Electronic Training Specialist (1st Shift)

About the role

Fagron is the global market leader in pharmaceutical medicine, with products sold to over 200,000 customers in 60 countries. Our mission is to "Together we create the future of the personalized medicine." We collaborate with prescribers, pharmacists, and customers to improve medications and support patients. As a market leader, we operate locally while thinking globally.

Responsibilities

• Trains new employees on batch issuance and review tasks.
• Led development of paper batch record training SOPs and TCPs.
• Provides training for Good Documentation Practices to new hires or for retraining purposes.
• Issues batch records in both paper and electronic formats, ensuring accuracy before production.
• Reviews batch records in paper format for accuracy and completeness according to SOPs and cGMPs.
• Handles the review of controlled substance batch records.
• Reviews electronic batch records and manages a heavier batch review load.
• Safeguards the completion of all applicable final quality testing and approval.
• Identifies deviations from processes and notifies relevant personnel for investigation initiation.
• Identifies, communicates, and tracks errors, suggesting process improvements.
• Disposes batches based on document review results and investigation outcomes.
• Understands and applies cGMP requirements and relevant SOPs.
• Suggests changes in documentation processes.

Requirements

• High School Diploma or GED.
• Previous training experience.
• Excellent verbal and written communication skills.
• Proficiency in Microsoft Office, MasterControl, Track Wise, or similar electronic compliance tools.
• Bachelor's degree in biology, chemistry, or a science-related field is preferred.
• Experience in pharmaceutical manufacturing (503B) is preferred.
• Full understanding of good documentation practices is mandatory.
• At least 2-3 years of experience as a Batch Release Assistant or 2 years of batch release experience plus 1+ years of relevant industry experience.

Qualifications

• Basic understanding of cGMP requirements and SOPs relevant to batch record review.
• Knowledge of FDA guidance and cGMPs.
• Ability to work independently and manage multiple tasks.
• Positive interaction with multiple functional areas.
• Ability to resolve batch record documentation issues.
• Understanding of final quality testing and approval processes.
• Identification and communication of trends in errors and root cause analysis.
• Ability to assist in completing corrections on batches.
• Ability to identify and communicate deviations relevant to batch release processes.

Skills

• Strong organizational and time management skills.
• Attention to detail.
• Ability to work independently and manage multiple tasks.
• Good interpersonal and communication skills.
• Proficiency in Microsoft Office and electronic compliance tools.

Benefits

• Competitive salary.
• Comprehensive benefits package.
• Performance-based compensation.
• Opportunity to work for an expanding, international pharmaceutical company.