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, small and large scale projects in order to complete departmental objectives.
1) Ensure Equipment Compliance:
a. Ensure equipment and technologies employed at the Client remain in compliance with local, global and regulatory policies, procedures and guidelines.
b. Receive and review revisions to USP, EP, JP, FDA and EU regulatory guidelines. Provide guidance to the team if changes are required.
c. Perform gap analysis on existing equipment and technologies to ensure compliance.
d. Review new equipment and technologies as it comes to site to ensure compliance.
2) Ensure ECQ Departmental Compliance:
a. Participate in revisions to departmental procedures to ensure compliance.
b. Ensure departmental procedures and policies comply with latest versions of local, global and regulatory policies, procedures and guidelines.
3) Historical Performance Review:
a. Execute the historical performance review (HPR), a bi annual review of equipment performance and use.
b. Compile data gathered from HPR and use to analyze trends that could show equipment failure or out of trend.
c. Review equipment logbooks, procedures and use for adherence to local, global and regulatory policies, procedures and guidelines.
d. Identify and recommend actions to take as a result of the completed HPR.
4) Compliance Projects:
a. Through job functions listed above identify and scope projects of small and large complexity required to keep equipment or the department in compliance.
b. Lead projects both small and large in scope required to keep equipment or the department in compliance.
6) Regulatory Responsibilities:
a. Assist in the preparation for both internal and external audits.
Required Competencies?Knowledge, Skills, and Abilities:
Knowledge, Skills & Abilities:
? 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 extensive background in database systems. Innate ability to learn new software, such as corporate intranet and enterprise business.
? Ability to lead cross functional teams.
? Ability to lead and influence others.
? Ability to organize and present clear
? Professional Knowledge
? Action and detail oriented
? Team Player / Building Relationships
? Customer Focus
? Problem Solving
? Active Listening
Education & Experience:
? BS in Engineering or Science related discipline preferred.
? Minimum 10 years? experience in FDA-regulated industry
? 4 years? experience in a quality assurance related discipline preferred.
? In depth knowledge of regulatory guidelines such as FDA, EMA, USP, EP and JP.
? Excellent computer skills including knowledge of calibration management and environmental monitoring systems
? Strong verbal and written communication skills, and the ability to work independently.
? Must have strong interpersonal and communication skills, be a team player and be willing to work in an environment where individual initiative, accountability to the team, and professional maturity are required
Physical / Mental Demands:
? Occasional stooping, bending, stretching, pushing, pulling, reaching and/or lifting up to 25lbs
? Ability to sit, stand, walk and move within workspace for extended periods
? Ability to perform repetitive tasks including hand to finger manipulations, grasping, pushing and pulling.
? Primarily office environment, but will be required to enter laboratory or GMP process areas donning proper gowning / lab coats or PPE such as safety glasses and shoes.
? Ability to work safely and effectively when working alone, or working with others.