Compliance Specialist
| Job Type | Permanent |
| Location | New York, USA |
| Area | New York , USA |
| Market | Life SciencesLife Sciences - ConstructionLife Sciences - Engineering |
| Salary | $100,000 - $140,000 |
| Currency | USD |
| Start Date | |
| Advertiser | Courtney Robb |
| Job Ref | IW-9654 |
- Description
- Compliance Specialist
New York
$100 - $140K basic salary USD
Seeking a professional and experienced Compliance Specialist who are looking for a new opportunity.
Responsibilities
- Provide support with regard to the CMMS program working with CMMS (preferably Blue Mountain Regulatory Asset Manager system) Work Record systems.
- Duties will include – Compliance Review of work records, data mining, oversight for aging records, generation of data reports.
- Perform work record reviews, perform equipment information updates, create and revise work plans.
- Routinely coordinate and manage cross-functional teams.
- Liaising with QA, Area Management, and personnel using the CMMS program to ensure productive and professional working relationship.
- Maintains knowledge of current good manufacturing practices cGMPs.
- Maintain required training status on client specific work instructions and SOP's.
- Strong interpersonal, written, and oral communication skills.
- Exhibits confidence has a high emotional IQ, and has strong interpersonal, written and oral communication skills for providing team updates.
- Shows resiliency and flexibility in the face of challenges and adversarial situations and tight deadlines.
- Understands and listens to team members and stakeholders needs while supporting productive team environments toward a common objective.
The role will entail excellent communication skills with all groups across the site, highly developed written and verbal skills, professionally liaising between area management and Quality Assurance, adherence to all levels of compliance within the Biopharma industry, a high level of organization abilities.
Qualifications
- 3 to 10 years of experience in biotech-pharmaceutical academic or industrial environment
- Proficient in CMMS software (preferably Blue Mountain Regulatory Asset Manager System) Work Record System
- Knowledge of Facilities – utilities (CS, CA, PS, CU), CIP, HVAC, metrology, process equipment, HEPA certification, non-clean room Facilities, and/or drug product manufacturing from formulation through the final package
- Basic knowledge of regulatory compliance inclusive of cGMP, FDA regulations, familiarity with ICH guidelines and EU regulations
- Proficient with Excel, PowerPoint, Visio, Word, Sharepoint, etc.
- Demonstrated experience with manufacturing processes and equipment such as CIP systems, filtration skids, chromatography and lyophilization equipment
- Provide leadership and expertise in projects and coordination and stakeholder communication / management
- Experience in either commissioning, validation or engineering is a plus
- Engineering degree in Chemical Engineering, Biochemical Engineering or Mechanical Engineering. Life Sciences degree as applicable (e.g. Biochemistry, Chemistry, Biology)
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