Quality Analyst I - SLC West (2:00 PM - 10:00 PM)

Role Summary

This position is primarily responsible for the review of batch record files and final product release for shipment to end customer and to participate in investigations and trending of quality issues as appropriate. Additionally, this position will support QA Production Operations for all manufactured batches and issue/review/release raw materials, labeling materials and packaging materials as needed and for providing general guidance and instruction to correct identified deficiencies during documentation reviews and other oversight as needed to ensure compliance with company procedures and domestic and international regulatory requirements.

Responsibilities

• Responsible for performing activities to support Production Operations which includes floor support, audit/walkthrough support, AQL assessment, investigation assessment, and training.
• Responsible for conducting review and release activities associated with product and material release with some oversight, but minimal and directed at anomalous issues or observations (including raw materials, intermediates and finished products).
• 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 issues related to human errors).
• 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.
• May be 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.
• May be responsible for revising or reviewing Standard Operating Procedures, forms and/or Work Instructions with changes of moderate complexity and responsible for ensuring accuracy and GMP compliance in documents that are being reviewed.
• May be responsible for compiling and maintaining metrics and tracking logs at the request of management and is responsible for successfully meeting metrics delivery schedules.
• Responsible for performing additional related duties as assigned.

Qualifications

• Required: Requires a 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 preferred.
• Required: Requires 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 systems such as Trackwise and Qdocs.
• Self-directed with ability to organize and prioritize work.
• Ability to communicate effectively with excellent written and oral communication skills.
• Ability to interact positively and collaborate with co-workers, management and external partners.

Education

• Bachelor’s degree or equivalent education/experience (as noted in Qualifications).
• ASQ Certification preferred.