Hobbs BrookWaltham (MA), 5 mi from Lexington (MA)
practice, benchmarks, comparable and other issues of concern.
• Responds to information requests from Asset Management and Senior Leadership.
Required Education:
• Bachelor's Degree
Required Work Experience:
• 3+ years of related real estate work...
OutlierBoston
Highlights:</strong></p><ul><li><strong>Flexible work schedule:</strong> Work whenever and wherever you want</li><li><strong>Weekly payouts:</strong> Automatically receive timely payments (no invoicing!)</li><li><strong>Un...
OutlierBoston
Highlights:</strong></p><ul><li><strong>Flexible work schedule:</strong> Work whenever and wherever you want</li><li><strong>Weekly payouts:</strong> Automatically receive timely payments (no invoicing!)</li><li><strong>Un...
OutlierBoston
Highlights:</strong></p><ul><li><strong>Flexible work schedule:</strong> Work whenever and wherever you want</li><li><strong>Weekly payouts:</strong> Automatically receive timely payments (no invoicing!)</li><li><strong>Un...
Maverick FXEverett
This is a remote/work from home position. As a contract business, traders will be their own boss, with the opportunity to work full-time or part-time from anywhere in the world with a high-speed internet connection. Operate from anywhere in the world with a high-speed internet connection.
Ability to...
LanceSoft, Inc.Cambridge, 7 mi from Lexington (MA)
and department standards, takes initiative to resolve discrepancies.
• Expert knowledge and working experience of the USPTO Patent Center filing system in order to independently draft and prepare simple to moderately complex patent legal documents for submission...
ThriveworksLexington (MA)
of an approved 60-credit hour program
• Graduate or post-graduate work experience in a counseling setting treating depression and anxiety required.
• Graduate or post-graduate work experience independently conducting intakes and diagnosing according to the DSM...
ThriveworksLexington (MA)
A graduate of an approved 60-credit hour program
• Graduate or post-graduate work experience in a counseling setting treating depression and anxiety required.
• Graduate or post-graduate work experience independently conducting intakes and diagnosing...
Get new jobs by email!
Get email updates for the latest Work Experience jobs in Lexington (MA)
It's free, and you can cancel email updates at any time
Senior Quality Lead/Sterility Assurance Lead - 4695
Lexington (MA) | www.resume-library.com |
Verista’s 600 experts team up with the world’s most recognizable brands in the life science industry to solve their business needs. The nature of our business is to empower growth and innovation within the scientific community and to help researchers, organizations, and companies solve some of the world’s most pressing healthcare challenges.
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 ability to grow is driven by world-class people who thrive in a team environment and share our mission to enable life sciences clients to improve lives. Our talented and dedicated professionals are committed to making an impact every day.
Company Culture Guidelines & Values:
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
Senior Quality/GxP Auditor 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.
Requirements
Must be willing to work onsite at least 3 days a week in Lexington, MA
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 FMEA)
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.
Proficiency using PC and Microsoft Office tools
Outgoing personality with strong ability to communicate effectively with peers in clear, concise terms
Ability to work as part of a team
Strong problem-solving and critical thinking skills
Excellent organizational and time management skills
Strong attention to detail
GMP and Good Documentation Practice
Intermediate skills with WORD (authoring/editing large technical documents with styles, tables, TOCs, track changes)
Basic skills with EXCEL and PowerPoint
Strong interpersonal skills and clear communication capabilities
Experience with and tolerance for high levels of challenge and change
Benefits
Why Choose Verista?
High growth potential and fast-paced organization with a people-focused culture
Competitive pay plus performance-based incentive programs
Company-paid Life, Short-Term, and Long-Term Disability Insurance.
Medical, Dental & Vision insurances
FSA, DCARE, Commuter Benefits
Supplemental Life, Hospital, Critical Illness and Legal Insurance
Health Savings Account
401(k) Retirement Plan (Employer Matching benefit)
Paid Time Off (Rollover Option) and Holidays
As Needed Sick Time
Tuition Reimbursement
Team Social Activities (We have fun!)
Employee Recognition
Employee Referral Program
Paid Parental Leave and Bereavement
For more information about our company, please visit us at
For US geography, the salary range for this position is shown below. 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.
Therefore, in some circumstances, the actual salary could fall outside of this expected range. This salary range is subject to change and may be modified in the future.
$120,000 - $151,463
• Verista is an equal opportunity employer.
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 ability to grow is driven by world-class people who thrive in a team environment and share our mission to enable life sciences clients to improve lives. Our talented and dedicated professionals are committed to making an impact every day.
Company Culture Guidelines & Values:
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
Senior Quality/GxP Auditor 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.
Requirements
Must be willing to work onsite at least 3 days a week in Lexington, MA
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 FMEA)
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.
Proficiency using PC and Microsoft Office tools
Outgoing personality with strong ability to communicate effectively with peers in clear, concise terms
Ability to work as part of a team
Strong problem-solving and critical thinking skills
Excellent organizational and time management skills
Strong attention to detail
GMP and Good Documentation Practice
Intermediate skills with WORD (authoring/editing large technical documents with styles, tables, TOCs, track changes)
Basic skills with EXCEL and PowerPoint
Strong interpersonal skills and clear communication capabilities
Experience with and tolerance for high levels of challenge and change
Benefits
Why Choose Verista?
High growth potential and fast-paced organization with a people-focused culture
Competitive pay plus performance-based incentive programs
Company-paid Life, Short-Term, and Long-Term Disability Insurance.
Medical, Dental & Vision insurances
FSA, DCARE, Commuter Benefits
Supplemental Life, Hospital, Critical Illness and Legal Insurance
Health Savings Account
401(k) Retirement Plan (Employer Matching benefit)
Paid Time Off (Rollover Option) and Holidays
As Needed Sick Time
Tuition Reimbursement
Team Social Activities (We have fun!)
Employee Recognition
Employee Referral Program
Paid Parental Leave and Bereavement
For more information about our company, please visit us at
For US geography, the salary range for this position is shown below. 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.
Therefore, in some circumstances, the actual salary could fall outside of this expected range. This salary range is subject to change and may be modified in the future.
$120,000 - $151,463
• Verista is an equal opportunity employer.