Sterility Assurance Assessment Lead

2 months ago

Lexington, United States Synergy Solutions Full time

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 site-specific 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 fast-paced 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: $50.00 - $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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