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REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities:

Understanding of cGMP, GXP, GAMP, SDLC regulations, including 21CFR part 11, computer systems validation requirements and good documentation practices.
Knowledge of pharmaceutical, manufacturing and laboratory systems qualification preferred.
Strong written and verbal communication skills.
Excellent interpersonal skills with experience dealing with a diverse workforce.
Strong multi tasking ability in conjunction with proven organizational skills. Ability to organize assigned tasks in a high-paced environment and concurrently monitor tasks/assignments with others that may impact timely completion. Ability to effectively manage multiple tasks and activities simultaneously.
Highly proficient computer skills in Microsoft Office Suite Word, Excel, PowerPoint, and Outlook with an extensive background in database systems. Innate ability to learn new software, such as corporate intranet and enterprise business.

EDUCATION and EXPERIENCE:

BS in Engineering or Science related discipline required.

DUTIES AND RESPONSIBILITIES:

1) Maintains qualified equipment systems in compliance with policies, guidelines and procedures:

2) Manages projects of limited scope and complexity within their functional area:

3) Provides excellent customer service and support: