SR BATCH REC AUD

Abbott is a global health care company devoted to improving life through the development of products and technologies that span the breadth of healthcare. With a portfolio of leading, science-based offerings in diagnostics, medical devices, nutritionals and branded generic pharmaceuticals, Abbott serves people in more than 150 countries and employs approximately 70,000 people.

Primary Function / Primary Goals / Objectives:

A.   Ensure all necessary documents are included within the batch record.
B.   Assure compliance to Federal Regulations pertaining to Low Acid Canned Foods, Infant Formula Quality Control, Acidified Foods, Bottled Water Regulations, Nutritional Labeling Laws, and Good Manufacturing Practices.
C.  Audit and assure accuracy of all batch records to be compliant with policies, procedures and regulatory requirements.
D. Maintain databases and batch record files to assure retrieval is accurate and timely. 
E.  Identify batch non-conformances and initiate appropriate actions for investigation and product disposition.
F.  Write job aids, guidelines, procedures, and maintain their accuracy.
G.  Assist with Quality Systems projects, reworks, holds, destructs etc.
H.  Play a lead role in resolving issues
 

Major Responsibilities:
Responsible for implementing and maintaining the effectiveness of the quality system.
A.  Coordinate batch record review and daily workflow based upon batch release priorities.
B.  Must be able to audit all work orders, including electronic batch record (EBR) review.

C. Batch audit:  Review work orders for completeness and compliance to all Abbott Nutrition policies, procedures, deviation requirements and government regulations.
D.  Perform first turn release.

E.  Initiate exception reports (ERs) and plant information reports (PIRs) and route to supervisor for disposition.
F.  Follow up on all issues to assure each is researched prior to submission of work order to supervisor. 
G.  Enter and maintain work orders, ERs and discrepancies and into the batch tracking system. 
H.  Ensure holds and isolations have been initiated and maintained as required. 
I.   Work with appropriate personnel for sampling plans, initiate sample requests, write inspection and reworks when necessary. 
J.  Use of the warehouse management and manufacturing execution systems to adjust or obtain release status for specific batches and/or materials. 

K.  Audit and maintain records for non-batch log related items (i.e. tank temperatures, Clean-in place (CIP) charts, metrics, batch record reviews).

L.  Identify and communicate with manufacturing personnel and management any issues or discrepancies that may require work order changes.

M.  Provide support for data collection, i.e.: Operations, Engineering and Quality Assurance (QA).
N.  Expedite batch review when asked to meet demands.
O.  Assist supervisor and QA Manager as business needs dictate.
P.  Documentation change control. 
Q.  Provide administrative support to QA manager and staff, including but not 
      limited to:
 -    Data input and tracking and trending, develop presentations
 -    Perform meeting setups, routing and distribution of paperwork, maintain office supplies.

Accountability / Scope/Budget:
The position will report directly to the CAPA Manager. The auditor is responsible for the complete audit of work orders in Quality Systems. This position is independent. Batch record auditors are expected to review their work for errors and correct them before submitting their work to the supervisor for review. Errors can result in FDA observations, corporate compliance audit observations, OSHA, Recall or other regulatory action. In many instances, this position will also be a resource to others within the department. 

Education:
Bachelors Degree in a technical field is required. 

The incumbent must show strengths in Abbott core competencies and effectively communicate with all plant manufacturing groups, plant Quality Assurance groups, plant management, Division Quality Assurance, Logistics, Material Control, PR&D groups, AR&S groups and Process Authority on technical subjects affecting product quality and plant operations.  The incumbent should have some technical knowledge in the areas of processing, filling, aseptic manufacture, chemistry, microbiology, computers as well as excellent oral and written communication skills.

Background:
Knowledge of applicable regulatory standards and requirements for infant formula and nutritionals.

a. Some knowledge of the manufacturing process including Analytical Processing and Filling preferred.
b. Proficient in computer applications (MS Office - Word, Excel, PowerPoint, Access, etc) with basic programming knowledge/skills.
c. Background in database management and spreadsheet development.

d. Proficient in writing SQL queries.

e. Ability to analyze and troubleshoot.
f.  Must have strong communication and writing skills.
g. Ability to prioritize workload to meet batch release timing.
h. Certification of Low Acid Food processes (course requirements).

The job description is illustrative of the types of duties typically performed by this job. It is not intended to be an exhaustive listing of each and every essential function of the job. Since job content may change from time to time, the Company reserves the right to modify this job description at any time.