Purpose and Scope of the Position
The Compliance Specialist, Equipment Commissioning & Qualification, supports the successful operation
of facility, laboratory, and business functions at multi‐use sites through interaction with internal team
members and peer‐level customers as well as external service providers. The incumbent in this
individual contributor role ensures the compliance of equipment and the ECQ group with local, global,
and regulatory guidelines. The incumbent will perform periodic reviews of equipment, policies and
procedures, gap analysis where required, and small-scale projects to complete departmental objectives.
Required Competencies- Knowledge, skills, and abilities
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- Advanced knowledge of cGMP, GXP, GAMP, SDLC regulations, including 21CFR part 11, computer
- systems validation requirements and good documentation practices.
- Advanced knowledge of pharmaceutical, manufacturing and laboratory systems and equipment.
- Strong attention to detail.
- 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. - Strong presentation development and delivery skills.
- 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. - Ability to organize and present data and findings clearly.
- Possess experience with investigation