Position Summary: DAY SHIFT 

The Quality Assurance Batch Reviewer reviews and approves manufacturing and packaging batch records, as well as raw material and packaging material test results. Ensures that all records comply with company procedures and cGMP.

Essential Duties and Responsibilities: To perform this job successfully, an individual must be able to perform the following satisfactorily; other duties may be assigned. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

· Reviews production batch records and associated data for product release.

· Reviews and releases packaging components and raw materials.

· Reviews lab report data for compliance to product specifications.

· Notifies Senior Quality Reviewer of deviations found during batch review.

· Interacts with clients and follows up on client inquiries.

· Submits change controls for SOPs, Product Specifications, Certificates of Analysis, and batch records that require revisions and deletions.

· Ensures completeness and accuracy of information contained in all documents, document files, databases, and documentation systems.

· Performs other related duties, as assigned.

Education/Experience:

· High School Diploma or equivalent required. Bachelor’s degree strongly preferred.

· Minimum 4 years of relevant experience in documentation review, QA or equivalent exposure. Knowledge of Fill Finish and production environments strongly preferred.

· Working knowledge of cGMP regulations environment strongly preferred.

Language Ability: Read, analyze and interpret business, professional, technical or governmental documents. Write reports, business correspondence and procedure manuals. Effectively present information and respond to questions from managers, customers and the public.

Mathematical Ability: Add, subtract, multiply and divide in all units of measure, using whole numbers, common fractions and decimals. Compute rate, ratio and percent, and draw and interpret bar graphs.

Reasoning Ability: Define problems, collect data, establish facts and draw valid conclusions. Interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.

Computer Skills: Intermediate knowledge of Microsoft Office Suite and email.

Supervisory Responsibilities: This job has no supervisory responsibilities.

Work Environment: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

The noise level in the work environment is usually moderate.

Work environment involves moderate risks or discomforts which require special safety precautions, e.g., working around moving machines in production facilities. Protective clothing or gear such as goggles, gloves and shoes may be required.

Computer Skills: Advanced Knowledge of Microsoft Office Suite, PDF programs, and email.

Work Remotely

• No

Physical Demands

• The employee must occasionally lift and/or move up to 10 pounds. While performing the duties of this job, the employee is regularly required walk, stand, talk and hear.