Sterility Assurance Assessment Lead - Lexington, United States - Synergy Solutions

Synergy Solutions
Synergy Solutions
Verified Company
Lexington, United States

4 weeks ago

Mark Lane

Posted by:

Mark Lane

beBee recruiter
Description
Initial 10 month contract with possible extension/conversion to permanent employment

3 days onsite per week in Lexington MA


Support Duration:

Phase 1 GAP Assessment Execution
Phase 2 CAPA Plan Delivery & Management


Primary Duties Responsibilities:


  • Execution of a Current State GAP Assessment of the Contamination Control Program of the client from a Global and sitespecific perspective.
  • Delivery of Current State Contamination Control Findings Report
  • Execution of microbial and/or cross contamination LOPA, HACCP &/or FMEA in identifying and assigning risk (RPN) of identified GAPs to define prioritization in overall CAPA Plan.
  • Delivery of Corrective and Preventive Action Plan based upon risk to remediate GAPs identified in Assessment.
  • Management and oversight of defined CAPA Plan with assigned Stakeholders at site; to drive delivery and promptly elevate concerns and/or roadblocks.

Required Qualifications:


  • Signification experience (7+ years) supporting site compliance to the global microbial/viral control standards/procedures on environmental monitoring, critical utilities, contamination control strategy, cleanroom management, microbiological methods and validations including RMM, sterilization and aseptic processing controls, disinfectant efficacy studies and microbial risk assessments.
  • Significant experience (7+ years) in a microbial contamination control role within the pharmaceutical or biotechnology industry.
  • Signification demonstrated experience in development and delivery of risk based CAPA plans.
  • Knowledge of cGMP/ICH/FDA/EU compliance regulations and USP, EP and JP monographs for microbiology
  • Strong knowledge of microbiological and sterility testing (i.e. environmental monitoring, clean room qualification and management, quality control endotoxin testing and microbiological control strategy)
  • Experience with oversight of aseptic processing and the associated international aseptic processing regulations.
  • Experience with microbiological risk assessments and prioritization techniques (LOPA, HAACP &/or FMEAA)
  • Comprehensive knowledge of global GMP and biologic regulatory requirements
  • Excellent oral and written communication skills with strong technical writing experience required.
  • Demonstrated ability to successfully execute responsibilities in a fastpaced environment, collaborating across corporate functions and multiple stakeholders to drive delivery of CAPA plans.
  • Ability to synthesize data and summarize outcomes to provide recommendations on a compliant path forward.

Job Disclaimer:


  • Equal Opportunity Employer/Veterans/Disabled_
  • The Company will consider qualified applicants with arrest and conviction records._

Job Type:
Contract


Pay:
$ $60.00 per hour

Expected hours: 40 per week


Benefits:


  • 401(k)
  • Dental insurance
  • Health insurance
  • Life insurance
  • Vision insurance

Schedule:

  • 8 hour shift
  • Day shift
  • Monday to Friday

Education:


  • Bachelor's (required)

Experience:

- microbial/viral control standards/procedures sit compliance: 7 years (required)

  • Microbial contamination control: 7 years (required)
  • Pharmaceutical/Biotech industry: 7 years (required)
- microbiological and sterility testing: 7 years (required)


Ability to Relocate:

  • Lexington, MA 02421: Relocate before starting work (required)

Work Location:
In person
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