Compliance Specialist

COMPLIANCE SPECIALIST
SUMMIT, NJ
100% onsite.

Required Skills:

• 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.
• 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.
• Working knowledge of regulatory guidelines such as FDA, EMA, USP, EP and JP.
• Possess experience with investigation.
• 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.
• Strong attention to detail.
• 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.

• 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.
• 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.

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.

This 12+ month position starts ASAP.

Please E-MAIL your resume (attachment to email) with rate and availability to Loren:

ALPHA'S REQUIREMENT
MUST BE ELIGIBLE TO WORK IN THE U.S. AS AN HOURLY W2 EMPLOYEE