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10 days old

Batch Record Auditor I

Kelly Services
Austin, TX 78703
Kelly is hiring a **Batch Record Auditor** for one of our medical device clients in **Austin, TX.**


+ Pay: $17/hr

+ Work hours: 8-5, Monday-Friday

+ 1 year contract to start


Position Summary:

The batch record auditor department is responsible for auditing batch records to ensure quality and compliance. The batch record auditor is responsible for auditing finished product batch records prior to product approval and release by the Batch Release Supervisor. He or she is responsible for auditing batch records in a timely manner.


Essential Duties & Responsibilities:

Audit batch records prior to product approval. Batch records are to be audited on a line by line basis.

Responsible for interaction with the respective business unit managers and/or supervisors for follow-up and corrective action if there are errors, inconsistencies, or deficiencies in documentation.

Enter batch record data and maintain a network database for each lot audited.

Set-up and maintain batch record files.

Review production schedules to determine deadlines and priorities.

Approve finished product batches on the Hi-Rise system prior to final approval by Batch Record Supervisor.

Updates area SOPs as needed.

Prepare and review Certificates of Analysis for accuracy.

Close out completed batch records and deliver them to the Batch Record storage area.

Train new batch record auditors.

Adhere to cGMP guidelines, SOP's and plant policies/rules.

Perform repetitive or routine duties working from detailed instructions and under standardized procedures.

Perform other related duties as assigned or required.


Knowledge, Skills & Qualifications:

Must be dependable and have demonstrated a good attendance rate (at or below plant standard).

Must have high attention to detail and the ability to recognize entry errors and omissions.

Must be able to compare recorded data against requirements and recognize discrepancies outside of written standards.

Must be able to facilitate correction of errors by effectively communicating with plant personnel at various levels.

Must have a strong knowledge of area SOPs and an understanding of the specification system.

Must be able to read and write English.

Must be able to effectively communicate and sometimes negotiate with supervisors in determining proper resolution to batch record discrepancies that would otherwise hold up the release of the batch record.

Must be able to use AS/400, Word, Excel, and Access database.

Must possess basic math skills (e.g. add, subtract, multiply, divide, work with fractions, decimals and percentages).

Must possess good written and verbal communication skills.

Must be able to work independently and within a team environment.

Must be organized and able to switch tasks when necessary.

Requires minor decisions (e.g if a batch record deficiency exists, if production Business Unit Manager/Supervisor requires notification, or if the completed production correction is acceptable without further documentation).

Requires mental / visual attention.


Education and Experience:

High School diploma or equivalent

Bachelors degree in a Science or Math related field preferred.

Minimum two (2) years prior experience in Quality or related area and/or related experience.

Must be familiar with plant batch records. Experience might be gained through completion of batch records in manufacturing, validation or checking of batch records in Quality.


**Why Kelly** **** **?**


Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.


**About Kelly** ****


At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)
Posted: 2021-09-13 Expires: 2021-10-14

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Batch Record Auditor I

Kelly Services
Austin, TX 78703

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