Quality Analyst I

Role Summary

This position is primarily responsible for the review of batch record files and final product release for shipment to end customers and to support Production Operations for all manufactured batches and issued materials. It also provides guidance to correct identified deficiencies during production walkthroughs and documentation reviews to ensure compliance with company procedures and domestic and international regulatory requirements.

Responsibilities

• Responsible for conducting review and release activities associated with manufactured product release with some oversight, but minimal and directed at anomalous issues or observations.
• Responsible for performing activities to support Production Operations which includes floor support, audit/walkthrough support, AQL assessment, investigation assessment, and training.
• Responsible for compiling and maintaining metrics and tracking logs at the request of management and is responsible for successfully hitting metrics delivery schedules.
• Responsible for reviewing and approving edits to Master Batch Records submitted for revision and for ensuring accuracy and GMP compliance in documents that are being reviewed.
• Responsible for supporting investigations and process improvement initiatives in the Quality and Production Areas as well as supporting ongoing quality and compliance initiatives at the site including support of Lean Management initiatives (TLMS) (i.e. reducing events or documentation related to human errors).
• Responsible for revising or reviewing Standard Operating Procedures (SOP’s), forms and/or Work Instructions with changes of low complexity and responsible for ensuring accuracy and GMP compliance in documents that are being reviewed.
• Responsible for completing all training requirements and maintaining compliance with all assignments.
• Responsible for maintaining work areas and performing job functions in a safe and efficient manner in accordance with company policies and procedures, Good Manufacturing Practices (cGMP’s), Standard Operating Procedures (SOP’s) and Batch Record instructions.
• Responsible for performing additional related duties as assigned.

Education

• Bachelor’s degree or equivalent education/experience with a minimum of three years relevant experience in a manufacturing environment within pharmaceutical, medical device, nutraceutical, or food processing industries.

Qualifications

• Required: Working knowledge of cGMP, DEA and other applicable industry regulatory requirements as they relate to the production of pharmaceutical products and associated quality systems.
• Preferred: ASQ Certification.

Skills

• Computer proficiency with comprehensive working knowledge of MS Office products, Learning Management Systems (LMS), ERP system such as SAP or Oracle and manufacturing/quality management systems such as TrackWise, Veeva and Glorya.
• Self-directed with ability to organize and prioritize work with ability to independently determine prioritization needs and demonstrate flexibility to adjust to changing priorities.
• Ability to communicate effectively with excellent written and oral communication skills.
• Ability to interact positively and collaborate with co-workers, management and external partners.