Verista, Inc.
6437 - Senior Quality Engineer / Senior Quality GxP Auditor
Boston, MA · Senior
Sponsorship not specified$70k-$114kDetected 15 days ago
Product ManagementGMPCRISPRCollaborationGxP
About the role
- Verista provides innovative solutions and services that empower informed decision-making and are the result of our significant investment in our people and our capabilities.
- Our talented and dedicated professionals are committed to making an impact every day.
- The actual salary is dependent upon a variety of job-related factors such as professional background, training, work experience, location, business needs, market demand, and competitive market practice.
Responsibilities
- Partner with Manufacturing, Validation, Engineering, Facilities, Laboratory Operations, Materials Management, and Capital Project teams to ensure GMP compliance throughout the product lifecycle.
- Validation & Engineering Support
- Support commissioning, qualification, and validation activities associated with manufacturing equipment, facilities, utilities, and capital projects.
- Provide Quality support for:
- Support Environmental Monitoring (EM), routine facility monitoring, and utility control programs.
- Provide oversight of facility monitoring systems including Building Management Systems (BMS), Environmental Monitoring Systems (EMS), ViewLinc, pest control, and related GMP-controlled programs.
Requirements
- Master's degree with 3-5 years of relevant Quality or Validation experience OR
- Experience providing QA oversight of GMP manufacturing operations.
- Experience supporting validation programs and capital projects within regulated pharmaceutical, biotechnology, or Cell & Gene Therapy environments.
- Strong knowledge of cGMP regulations, quality systems, and validation principles.
- Experience supporting aseptic manufacturing operations.
- Experience reviewing validation documentation, engineering documentation, and quality system records.
- Experience working with electronic quality systems such as:
Nice to have
- Competitive pay plus performance-based incentive programs
Compensation
- For US geography, the salary range for this position is shown below.
Benefits
- Company-paid Life, Short-Term, and Long-Term Disability Insurance.
- Medical, Dental & Vision insurances
- FSA, DCARE, Commuter Benefits
- Health Savings Account
- 401(k) Retirement Plan (Employer Matching benefit)
- Paid Time Off (Rollover Option) and Holidays
- Tuition Reimbursement
- Paid Parental Leave and Bereavement
Company info
- We empower and support our colleagues
- We commit to client success at every turn
- We have the courage to do the right thing
- We encourage an inclusive environment where our colleagues feel respected, engaged, and challenged.
- We constantly acquire new skills and learn from our experiences to enhance our collective expertise
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