Job description

Job Description:
Experience writing deviations/investigations.
Target: draft 5 minor deviations per week and have 3-5 approved and/or Draft 2-4 major deviations per week.

1. Manufacturing Technical Writers (Deviation authors)
Strong biologics exp
Strong understanding of unit operations – cell culture, bioreactor, TFF, Chromatography, filtrations, etc.
Strong knowledge of Single use disposable systems
Preferred exp. in mfg but quality and/or validation setting exp is acceptable as long as unit ops familiarity exists
Proven exp. With authoring, reviewing, approving deviations/non-conformances.
Trained with understanding of RCA techniques – 5Whys, 6Ms, fishbone, etc.
Have worked with batch records and have familiarity with workings of cGMP mfg environment.

Life science or engineering degree with at least 5+ yrs of direct relevant exp.
Use of Track Wise system or similar operating framework
Strong writing skills is a must.

Upstream
Large Molecule
Bio Tech
QA Batch Record Reviewer
- Strong understanding of quality systems and compliance requirements
- Working with batch records and associated process/systems
- Biologics experience with understanding of unit operations - cell culture, bioreactor, TFF, Chromatography, filtrations
- Familiarity with Single use disposable systems
- Batch Records & cGMP experience- Strong biologics experience
- Biologics experience with understanding of unit operations - cell culture, bioreactor, TFF, Chromatography, filtrations
- Familiarity with Single use disposable systems
- Trained with understanding of RCA techniques - 5Whys, 6Ms, fishbone, etc.
- Proven exp. with authoring, reviewing, approving deviations/non-conformances.

Job Type: Contract

Pay: Up to $55.00 per hour

Schedule:

• 8 hour shift

Ability to commute/relocate:

• Allen, TX: Reliably commute or planning to relocate before starting work (Required)

Experience:

• Microsoft Powerpoint: 1 year (Preferred)

Work Location: In person

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