Vacancy expired!
COMPLIANCE SPECIALIST, EQUIPMENT COMMISSIONING & QUALIFICATION SUMMIT, NJ 100% Onsite. Project Description:
- 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.
- Historical Performance Review:
- Execute the historical performance review (HPR), a periodic review of equipment performance and use.
- Compile data gathered from HPR and use to analyze trends that could show equipment failure or out of trend.
- Review equipment logbooks, procedures and use for adherence to local, global, and regulatory policies, procedures, and guidelines.
- Identify and recommend actions to take because of HPR findings.
- Write deviation and perform investigation per internal procedure.
- Track HPR recommendations and remediation actions.
- Ensure ECQ Departmental Compliance:
- Participate in revisions to departmental procedures to ensure compliance.
- Ensure departmental procedures and policies comply with latest versions of local, global, and regulatory policies, procedures, and guidelines.
- Compliance Projects:
- Through job functions listed above identify and scope projects of small and large complexity required to keep equipment or the department in compliance.
- Lead projects both small and large in scope required to keep equipment or the department in compliance.
- Ensure Equipment Compliance:
- Receive and review revisions to USP, EP, JP, FDA regulatory guidelines. Provide guidance to the team if changes are required.
- Perform gap analysis on existing equipment and technologies to ensure compliance.
- Review new equipment and technologies as it comes to site to ensure compliance.
- Regulatory Responsibilities:
- Assist in the preparation for both internal and external audits.
- BS in Engineering or Science related discipline w/minimum 8 years' experience OR MS w/6 years' experience in GMP environment/regulated industry .
- 5-7 years' experience in a pharmacopeia compliance related discipline preferred.
- 5-7 years' experience with troubleshooting complex laboratory equipment.
- Working knowledge of regulatory such as FDA, EMA, USP, EP and JP.
- Excellent computer skills including knowledge of equipment data quality 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.
- 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 organize and present data and findings clearly.
- Possess experience with investigation
- Physical / Mental Demands:
- Occasional stooping, bending, stretching, pushing, pulling, reaching and/or lifting up to 25 lbs .
- 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.
Vacancy expired!