Quality Assurance - Batch Record Review Assistant (Pharma) - Full-time / Part-time

This is a Temp-to-Hire position. Our client is in immediate need of a Document Control Batch Record Reviewer.

Description:

The Quality Assurance - Batch Record Review Assistant is responsible for making sure that the company complies with Standard Operating Procedures as well as federal regulations for each batch record and associated records of company product paperwork.

Hours: Monday - Friday 7:30 a.m. - 4:00 p.m.

Hourly salary: $12.00 - $14.00 contingent upon prior experience

Principal duties and responsibilities for this position include:

· Purge expired batches as per Standard Operating Procedure

· Perform critical checks and calculations in product batch record and packaging paperwork

· Organize product batch records and associated records

· Communicate product status to other departments on demand

· Pull batches for APRs or for special projects or investigations as required

· Perform product destruction paperwork and reconciliation calculations of batch packaging paperwork accordingly

· Other duties as assigned by the Quality Assurance – Batch Record Review Supervisor

Qualifications:

· Computer proficiency word, access, excel

· Strong verbal and written, communication skills, as well as exceptional organizational skills and ability to prioritize and multi-task

· Strong communication skills both verbal and written (Report Writing) (Data Analysis) also not afraid to be assertive

· Excellent analytical, problem-solving and decision-making skills

· Physical Requirements – ability to bend, twist, reach, climb ladders, lift materials up to 50 lbs

· Take responsibility for any errors and initiate corrective action as required.

· Must have good vision, aided by glasses if Necessary

· Experience in pharmaceutical environment preferred

· In-depth knowledge of cGMPs, FDA, USP, CFR requirements

· Prior Document Control Review experience would be A+