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Risk Management Compliance Specialist
Ref No.: 18-08684
Location: Summit, New Jersey
Position Type:Contract
Start Date / End Date: 07/09/2018 to 12/22/2018
Sunrise System Inc. is currently looking for Risk Management Compliance Specialist in Summit, NJ with one of our top client.
Job Title: Risk Management Compliance Specialist
Job Id: 18-08684
Location: Summit, NJ 07901
Duration: 5 months
Position Type: Hourly contract Position (W2 only)
Desired Skills
  • 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. 
Essential Functions
  • Ensure Equipment Compliance
  • Ensure equipment and technologies employed at the Client remain in compliance with local, global and regulatory policies, procedures and guidelines.
  • Receive and review revisions to USP, EP, JP, FDA and EU 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. 
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.
  • Historical Performance Review:
  • Execute the historical performance review (HPR), a bi annual 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 as a result of the completed HPR.
  • 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. 
Regulatory Responsibilities
  • 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 Competencies
  • Professional Knowledge
  • Action and detail oriented
  • Team Player / Building Relationships
  • Multi-tasking
  • 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 Working Conditions: 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. 
Environmental Conditions
  • 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. 
Contact
Sunny Rajput
Direct: (732) 272 20302 | Email: Sunny.R@sunrisesys.com
Or
Sourabh Agrawal | Lead - Talent Acquisition
Direct: (732) 272 0301| Email: sourabh@sunrisesys.com