manufacturing compliance specialist in Austin, TX at DISYS

Date Posted: 10/9/2018

Job Snapshot

Job Description

Job description:

Major Duties and Responsibilities:

Provides a real time, production-floor audit, of process manufacturing batch records.

Audits each page of the batch record, identifies that appropriate equipment and commodities are being used for the respective application, and ensures process steps are documented in timely and accurate manner. Identifies discrepancies in batch record audit and escalates to appropriate individuals for investigation and corrective action.

Responsible for final manufacturing signature on production batch record.

Tracks and trends batch record errors, identifies gaps, and provides feedback to business unit staff in an effort to confirm corrective actions and minimize compliance risk.

Identifies continuous improvement opportunities through the completion of routine manufacturing audits, log books, safety, gowning room, and other operational disciplines, as defined, in manufacturing SOPs. .

Confirms compliance gaps, escalates, and helps develop improvement plans. Evaluates opportunities for streamlining the manufacturing process.

Identifies and supports the implementation of standard work practices.

Responsible for providing process evaluation/analysis, preparing written reports, summaries, and memos, as necessary.

Adheres to guidelines, SOPs, and plant policies.

Performs other duties, as assigned.

 

Skills/Experience/Education:

Associate's Degree is required (Engineering or Science related preferred).

2-3 years prior experience in manufacturing operations, preferably in pharmaceutical, food, or cosmetic industry.

Job Requirements

Job description:

Major Duties and Responsibilities:

Provides a real time, production-floor audit, of process manufacturing batch records.

Audits each page of the batch record, identifies that appropriate equipment and commodities are being used for the respective application, and ensures process steps are documented in timely and accurate manner. Identifies discrepancies in batch record audit and escalates to appropriate individuals for investigation and corrective action.

Responsible for final manufacturing signature on production batch record.

Tracks and trends batch record errors, identifies gaps, and provides feedback to business unit staff in an effort to confirm corrective actions and minimize compliance risk.

Identifies continuous improvement opportunities through the completion of routine manufacturing audits, log books, safety, gowning room, and other operational disciplines, as defined, in manufacturing SOPs. .

Confirms compliance gaps, escalates, and helps develop improvement plans. Evaluates opportunities for streamlining the manufacturing process.

Identifies and supports the implementation of standard work practices.

Responsible for providing process evaluation/analysis, preparing written reports, summaries, and memos, as necessary.

Adheres to guidelines, SOPs, and plant policies.

Performs other duties, as assigned.

 

Skills/Experience/Education:

Associate's Degree is required (Engineering or Science related preferred).

2-3 years prior experience in manufacturing operations, preferably in pharmaceutical, food, or cosmetic industry.

Digital Intelligence Systems, LLC. is an Equal Opportunity Employer, M/F/D/V. We do not discriminate against any employee or applicant because they inquired about, discussed, or disclosed compensation. Email recruitinghelp @ disys.com to contact us if you are an individual with a disability and require accommodation in the application process.