Job Opening - Batch Record A|
uditor - Temp
B asic Function and Responsibility:
This temporary position is responsible for performing
audits of commercial and validation executed batch records for compliance to specification requirements, G&W
procedures, and Current Good Manufacturing Practices (cGMPs).
W ork Performed:
Perform audits of executed batch records for accuracy and completeness against checklists, G&W procedures and cGMPs.
Review for properly completed procedural pages, signatures, inspection sheets, material forms, temperatures charts, closed investigations, product yields, batch reconciliations, calculations, etc. and providing observations.
Verifying finished product quantities and checks.
Entering batch record data into the Annual Product Review System.
Maintain appropriate records of all audits.
A spects of Performance:
Possesses sound analytical problem-solving
and documentation skills.
Demonstrates ability to prioritize
Executes assigned tasks within established
Writes and speaks clearly and concisely.
Develop and maintain expertise through
continuing professional education and training.
Comply with company policies, procedures,
rules and regulations.
Experience auditing pharmaceutical product batch records.
An understanding of pharmaceutical manufacturing processes
Knowledge of the current Good Manufacturing Practices and the ability to apply that knowledge to batch record review.
Good verbal and written and organizational skills. The position requires that the employee communicate with internal and external management groups in order to assure that non-compliant observations noted during audits are addressed.
Strong computer skills, Microsoft Office Applications (Access, Excel and Word).
Ability to follow through and consistently demonstrate that all primary job duties and responsibilities are current and up to date; ability to monitor and communicate progress to Management.
Must be able to work as a team member.
Must be able to work a consistent schedule to satisfy the responsibilities of the job.
Knowledge of electronic document systems.
A minimum of three to five years of quality assurance experience in the pharmaceutical industry.