- We empower and support our colleagues
- We are committed to client success at all times
- We have the courage to do what's right
- We promote an inclusive environment that fosters respect, engagement, and growth for our team members
- We continuously expand our skills and leverage our experiences to enhance our collective knowledge
- Conduct a Current State GAP Assessment of the client's Contamination Control Program on a global and site-specific scale
- Submit a report on Current State Contamination Control Findings
- Perform microbial and/or cross contamination LOPA, HACCP &/or FMEA to assess and assign risk levels to identified GAPs for prioritization in the overall CAPA Plan
- Develop a Corrective and Preventive Action Plan based on risk assessment to address identified GAPs
- Oversee and manage the CAPA Plan with designated Stakeholders at the site; ensuring timely resolution of issues and roadblocks
- Ability to work onsite at least 3 days a week in Lexington, MA
- Extensive experience (7+ years) in ensuring site compliance with global microbial/viral control standards and procedures related to environmental monitoring, critical utilities, contamination control strategy, cleanroom management, and microbiological methods
- Significant background (7+ years) in a microbial contamination control role within the pharmaceutical or biotechnology sector
- Demonstrated experience in creating and implementing risk-based CAPA plans
- Familiarity with cGMP/ICH/FDA/EU compliance regulations and microbiology-related monographs such as USP, EP, and JP
- Strong expertise in microbiological and sterility testing, including environmental monitoring, cleanroom qualification, quality control endotoxin testing, and microbiological control strategy
- Experience in overseeing aseptic processing and adhering to international aseptic processing regulations
- Proficiency in conducting microbiological risk assessments and utilizing prioritization techniques (LOPA, HAACP &/or FMEA)
- Thorough understanding of global GMP and biologic regulatory standards
- Excellent verbal and written communication skills with a focus on technical writing
- Proven ability to execute tasks efficiently in a fast-paced setting, collaborating cross-functionally to implement CAPA plans
- Capability to analyze data and provide recommendations for compliant actions
- Proficient in PC and Microsoft Office tools
- Effective interpersonal skills and clear communication abilities
- Experience in managing challenges and adapting to change
- Strong problem-solving, organizational, and time management capabilities
- Attention to detail and adherence to GMP and Good Documentation Practice
- Intermediate skills in WORD for creating/editing technical documents
- Basic skills in EXCEL and PowerPoint
- Team-oriented with the ability to collaborate effectively
- Opportunity for significant professional growth in a dynamic organization with a people-centric culture
- Competitive compensation along with performance-based incentives
- Company-provided Life, Short-Term, and Long-Term Disability Insurance
- Healthcare coverage including Medical, Dental, and Vision insurances
- Additional benefits such as FSA, DCARE, and Commuter Benefits
- Supplemental insurance options like Life, Hospital, Critical Illness, and Legal Insurance
- Health Savings Account and 401(k) Retirement Plan with Employer Matching
- Paid Time Off with Rollover Option, Holiday pay, and Sick Time
- Tuition Reimbursement for continuous learning
- Engaging Team Social Activities
- Employee Recognition initiatives
- Employee Referral Program
- Paid Parental Leave and Bereavement Support
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Senior Quality Lead/Sterility Assurance Lead - Lexington, United States - Verista
Description
Job Description
Verista's team of 600 experts partners with top brands in the life science industry to address their business requirements. Our focus is on fostering growth and innovation within the scientific community to assist in tackling healthcare challenges. Verista offers cutting-edge solutions and services to support well-informed decision-making, thanks to our continuous investment in our team and capabilities.
Our growth is fueled by exceptional individuals who excel in collaborative environments and share our goal of helping life sciences clients enhance quality of life. Our dedicated professionals are passionate about making a difference every day.
Company Culture Guidelines & Values:
Senior Quality/GxP Auditor Responsibilities:
Requirements
Benefits
Why Join Verista?
For additional details about our company, please visit our website.
Salary Range for this position in the US:
$120,000 - $151,463
*Verista is proud to be an equal opportunity employer.
