Job Description

Target Pay Rate: 40-56.33/hr **salary will be commensurate with experience 

Description: Responsible Subject Matter Expert for a specific function to evaluate and approve production department generated documentation (e.g. electronic and paper batch records). Ability to review API (active pharmaceutical ingredients) and Drug substance product to support on-time release of product. Ability to provide technical guidance to production operators and management.
Includes identifying and assessing deviations in the batch records using scientific principles, thorough analysis, and compliance minded thought processes which meet cGMP requirements within established timelines.

Skills & Qualifications: (education, experience):
Bachelors degree in a scientific/ technical field.
Minimum 7 years of overall experience in the biopharmaceutical, biologics, medical device or related industry, along with knowledge and understanding of cGMP concepts, and applicable US and foreign regulations. A minimum of four years of direct experience in Manufacturing and/or Quality in a GMP-regulated industry or an equivalent combination of education and experience.
* Must have previous experience reviewing and approving pharmaceutical manufacturing electronic and paper batch records and understand the review and approval process. Previous work in Quality Assurance (e.g., release) preferred.
* Proven ability as a team player and leader.
* Excellent interpersonal skills
* Must be able to listen and understand the opinions and perspectives of others while influencing without authority with internal and external customers/stakeholders regarding possible recommendations.
* Ability to work both independently and team environment.
* The ability to multitask and support changing priorities
* Strong written and oral communication skills
* Ability to assess, investigate and resolve deviations.
* Strong ability to plan and prioritize complex and conflicting objectives to meet release goals and manage multiple priorities
* In depth knowledge of GMP

Job Tags

Contract work,

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