Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 113,000 colleagues serve people in more than 160 countries.

Primary Function / Primary Goals / Objectives:

a.    Audit and assure accuracy of batch records to be complaint with policies, procedures and regulatory requirements.
b.    Ensure all necessary documents are included within the batch record.
c.    Maintain databases and batch record files to assure retrieval is accurate and timely.
d.    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.

Major Responsibilities:

Responsible for implementing and maintaining the effectiveness of the quality system.
a.    Batch audit:  Review work orders for completeness and compliance to all Abbott policies, procedures, IOP requirements and Government regulations.
b.    Initiate QR’s, PIR’s and route to QS management for disposition.
c.    Follow up on all work order issues to assure each is researched prior to submission of work order to Supervisor or Senior Batch Records Coordinator, QS specialist or QS management. 
d.    Ensure holds and isolations have been initiated as required.
e.    Works with appropriate personnel for sampling plans, initiate sample requests, write inspection and reworks when necessary.
f.    Use of CAMBAR and AMAPS to adjust or obtain release status for specific batches.
g.    Audit and maintain records for non-batch log related items (i.e.:  Tank Temps, CIP charts.)
h.    Identify and communicate with manufacturing personnel and QA management any issues or discrepancies that may require work order changes.
i.    Responsible to train new employees where needed.
j.    Complete COA’s for Abbott domestic and international products. 
k.    Provide support for data collection, i.e.:  PQA lab, Engineering and DQA.
l.    Expedite batch review when asked by Division to meet consumers demands.
m.    Assist supervisor as business needs dictate.
n.    On occasion, may provide administrative support to PQA manager and staff, including but not limited to:
•    Data input and tracking and trending QA data, stats, test results, product pathway protection listing
•    Develop presentations for QA staff
•    Perform meeting setups, routing and distribution of paperwork, maintain office supplies
•    Perfect batch reports, product storage requirements, SQE database

 
Education:
Indicate the minimum education and why it is required.
Bachelors’ degree in a technical field preferred.  High school diploma or equivalent required.

Background:
Knowledge of applicable regulatory standards and requirements for infant formula and nutritionals.
Some knowledge of the manufacturing process including Analytical, Processing and Filling preferred. Proficient in computer applications. Ability to analyze and trouble shoot. Must have strong communication and writing skills. Ability to prioritize workload to meet batch release timing. Certification of Low Acid Food processes (course requirements)

","industry":"Healthcare","title":"Batch AuditorDivision: ANSC Nutrition Supply Chain
Travel: No
Medical Surveillance: No
Significant Work Activities: Keyboard use (greater or equal to 50% of the workday)