12 COMPLIANCE SPECIALIST Jobs in Summit, NJ
ARTECH is Hiring a COMPLIANCE SPECIALIST Near Summit, NJ
12 months contractPurpose And Scope Of The PositionThe 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
- 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
- Strong presentation development and delivery skills.
- Highly proficient computer skills in Client Office Suite – Word, Excel, PowerPoint, and Outlook with extensive background in database systems. Innate ability to learn new software,
- Ability to organize and present data and findings clearly.
- Possess experience with investigation
- Required 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 guidelines 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
Duties And Responsibilities
- 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.
- 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.
Job Summary
Contractor
Business Services
$97k-122k (estimate)
06/27/2024
07/21/2024
artech.com
READING, PA
3,000 - 7,500
1998
Private
JEFFREY LEWIS
$500M - $1B
Business Services
Related Companies
About ARTECH
Artech provides staff augmentation, program management, ERP and workforce and staffing solution.
The job skills required for COMPLIANCE SPECIALIST include Initiative, Written Communication, Presentation, PowerPoint, Verbal Communication, Communication Skills, etc. Having related job skills and expertise will give you an advantage when applying to be a COMPLIANCE SPECIALIST. That makes you unique and can impact how much salary you can get paid. Below are job openings related to skills required by COMPLIANCE SPECIALIST. Select any job title you are interested in and start to search job requirements.
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