Top 854 Senior information specialist Jobs in Boston, Ma

GMP Operational Quality Senior Specialist (Stability)
Vertex Pharmaceuticals —Boston, MA
- $94,200 - $141,200 a year
- Full-time
- Hybrid work
- 3 years
- Bachelor's degree
- Organizational skills
- Loan repayment program
- Dental insurance
Implementation Success Senior Specialist - USA, Canada and UK
Storyblok —Boston, MA
- $98,100 - $142,000 a year
- Remote
- English
- Continuous improvement
- Senior level
- Parental leave
- Flexible schedule
Senior Director of Information Technology
The Brattle Group, Inc. —Boston, MA
- $250,000 - $275,000 a year
- Computer science
- Azure
- Computer Science
Senior Education LMS Specialist
IHI —Boston, MA
- $64,417 - $103,067 a year
- Full-time
- Remote
- Computer literacy
- Analysis skills
- Bachelor's degree
- Health insurance
- Dental insurance
Registered Nurse (RN) Specialist
Monarch Communities —Beverly, MA
- $120 - $130 a year
- Full-time
- Nursing
- Microsoft Excel
- Microsoft Outlook
- AD&D insurance
- Paid holidays
Quick Apply
10d
AIRx, Sr. Director, Nonclinical Safety Lead
Takeda Pharmaceutical —Boston, MA
- $212,000 - $333,190 a year
- Call employer
- Hybrid work
- 11+ years
- Business development
- Doctor of Philosophy
- Paid holidays
- Disability insurance
Animal Compliance Specialist
Resource Logistics, Inc. —Boston, MA
- $25 - $30 an hour
- Contract
- Mid-level
- 3 years
- Bachelor's degree
Quick Apply
4d
Finance & Administrative Support Specialist
Unitarian Universalist Church of Greater Lynn —Swampscott, MA
- $26 - $34 an hour
- Part-time
- Microsoft Excel
- Microsoft Outlook
- Customer service
- Paid time off
- Flexible schedule
Quick Apply
1d
Manager or Senior Manager - Credits, Grants, and Incentives (AMCS)
KPMG —Boston, MA
- $105,640 - $223,100 a year
- Full-time
- Microsoft Excel
- Management
- CPA
- Disability insurance
- Health insurance
Head, AIRx Biologics Discovery
Takeda Pharmaceutical —Boston, MA
- $212,000 - $333,190 a year
- Full-time
- Hybrid work
- 11+ years
- Doctor of Philosophy
- Senior level
- Paid holidays
- Disability insurance
6d
Account Specialist
Northeastern Promotions —Bedford, MA
- $18 - $25 an hour
- Full-time
- Background check
- Sales
- No experience needed
- On-the-job training
- Opportunities for advancement
Quick Apply
1d
Engineering Specialist (DevOps) Lead
Fresenius Kabi —North Andover, MA
- $170,000 - $180,000 a year
- Full-time
- Hybrid work
- Background check
- Azure
- DevOps
- Wellness program
- Paid holidays
Quick Apply
Executive Director, AIRx Program Lead: Biologics
Takeda Pharmaceutical —Boston, MA
- $238,000 - $374,000 a year
- Hybrid work
- 11+ years
- Doctor of Philosophy
- Senior level
- Paid holidays
- Disability insurance
Roving Recertification Specialist
Peabody Properties, Inc. —Braintree, MA
- $75,000.00 - $79,497.60 a year
- Full-time
- Spanish
- Microsoft Excel
- Computer literacy
- Paid training
- Paid holidays
Quick Apply
Nurse Care Manager Brookline 40 hour
Hebrew SeniorLife —Brookline, MA
- $86,670.93 - $130,007.00 a year
- Full-time
- Microsoft Word
- Vital signs
- Urgent Care
Quick Apply
Archive Senior Specialist, Global Quality Systems and Compliance (Contract)
Vertex Pharmaceuticals —Boston, MA
- $46 - $49 an hour
- Temporary
- Microsoft Excel
- Mid-level
- 3 years
Senior Manager, Mutual Fund Tax
KPMG —Boston, MA
- Full-time
- CPA
- Office
- 8 years
- Disability insurance
- Health insurance
GMP Supply Chain Sr. Specialist - Planner/Buyer (contract) 29680
Vertex Pharmaceuticals —Boston, MA
- $60 - $70 an hour
- Full-time
- Writing skills
- ERP systems
- Research
Tax Manager/Tax Senior Manager, Real Estate
KPMG —Boston, MA
- Full-time
- CPA
- 5 years
- Office
- Disability insurance
- Health insurance
Senior Environmental Compliance Specialist
Atlas —Massachusetts
- Full-time
- Hybrid work
- Travel
- Senior level
- Leadership
- Paid parental leave
- AD&D insurance
Quick Apply

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GMP Operational Quality Senior Specialist (Stability)

Vertex Pharmaceuticals -
Boston, MA

Apply Now

Job Details

Full-time
$94,200 - $141,200 a year

Benefits

Loan repayment program
Dental insurance
Tuition reimbursement
Paid time off
Vision insurance
401(k) matching

Qualifications

Incident investigation techniques for hazard identification
Dissolution testing
USP standards
Stability testing
Communication with suppliers
Controlling experience
Content creation for technical audiences
Defect resolution root cause analysis
Stability studies in drug product development
Laboratory document review
Document control experience within pharmaceutical industry
Preventive action implementation
High-performance liquid chromatographs
Technical writing experience within manufacturing
Production deviation management
Laboratory information management systems
Corrective and preventive actions (CAPA)
Contract management experience in manufacturing
Internal investigations
3 years
ICH guidelines
Bachelor's degree
Quality risk management
Pharmaceutical analysis
Quality assurance experience within pharmaceutical industry
Organizational skills
Quality control problem-solving
Regulatory/legal compliance standards in production
Operational excellence initiatives
Senior level

Full Job Description

Job Description

General Summary:

The GMP Operational Quality Senior Specialist is recognized as a subject matter expert in the principles and application of quality assurance and regulatory compliance. The incumbent supports or executes a wide range of straightforward activities, and supports new/existing project initiatives. The role works with a high degree of independence and coordinates GMP activities to provide QA Analytical support for commercial product stability programs and executes routine tasks and activities in support of QA Analytical function.

Key Duties and Responsibilities:

Provides QA review of the GMP data in support of commercial product stability as required.

Has a good understanding of stability requirements per ICH and experience in stability protocol management.

Collaborate with internal and external business partners to resolve quality issues to ensure compliant solutions in support of QA Analytical function.

Represents QA Analytical on cross-functional teams as an experienced Quality technical resource as needed.

Supports quality oversight of Root Cause Analysis (RCA) and product impact assessment for deviation and OOS/OOT investigations. Ensure that appropriate CAPA actions are identified. May approve investigations/CAPAs.

Manages stability impacting change control activities such as assessment, implementation, and closure.

Conducts GMP document review, including procedures, work instructions, specifications, methods, protocols, and reports.

Supports external stability program activities for commercial products such as internal/external protocol review/approval, data review/approval and study initiation.

Enforces Quality Agreements between CMOs/Suppliers and Vertex as applicable to stability study pulls, test initiation, data reporting and OOS/OOT management.

Identifies and facilitates continuous improvement efforts.

Identifies and communicates risks and assists with risk mitigation plans, where applicable.

Knowledge and Skills:

Knowledge of both the conceptual and practical application of cGMPs in a pharmaceutical setting including knowledge of global GMP requirements in regard to GMP manufacturing and testing.

Knowledge of basic analytical techniques in a Quality/commercial setting (e.g., HPLC, dissolution, GC, KF, etc.)

Experience in supporting Quality Event Investigations, RCA and CAPA implementation.

Experience in assessing and managing Change Controls

Experience working with Contract Manufacturing Organizations (CMOs)/Contract Testing Organization (CTOs).

Experience supporting multiple projects/teams, ability to work in a fast-paced environment and meet quality, accuracy and timelines.

Demonstrated ability to evaluate quality matters and make decisions leveraging technical experience and judgement.

Good communication skills (written and verbal) and the ability to communicate cross-functionally to a variety of audiences.

Demonstrated ability to work independently to provide QA advice for large, multifaceted projects

Experience in supporting Quality Event Investigations, RCA and CAPA implementation.

Experience in assessing Change Controls

Experience with electronic document management systems (e.g., LIMS, Veeva).

Education and Experience:

Bachelor's degree in a scientific discipline (or equivalent degree) and 3-4 years of experience, or the equivalent combination of education and experience.

Advance knowledge of GMP regulations and applicability.

Operational QA experience in analytical or manufacturing setting, interpretation, and application of GMPs and applicable guidelines/guidance’s ex. ICH, USP, etc.

Experience in Root Cause Analysis tools/methodology and technical writing.

Facilitation/problem solving/organizational planning skills in a regulated environment.

Pay Range:

$94,200 - $141,200

Disclosure Statement:

The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law.

At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more.

Flex Designation:

Hybrid-Eligible Or On-Site Eligible

Flex Eligibility Status:

In this Hybrid-Eligible role, you can choose to be designated as:
1. Hybrid : work remotely up to two days per week; or select
2. On-Site : work five days per week on-site with ad hoc flexibility.

Note: The Flex status for this position is subject to Vertex’s Policy on Flex @ Vertex Program and may be changed at any time.

#LI-Hybrid

Company Information

Vertex is a global biotechnology company that invests in scientific innovation.

Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at [email protected]

Apply Now

Refine Your Search

senior information specialist jobs in boston, ma

GMP Operational Quality Senior Specialist (Stability)

Implementation Success Senior Specialist - USA, Canada and UK

Senior Director of Information Technology

Senior Education LMS Specialist

Registered Nurse (RN) Specialist

AIRx, Sr. Director, Nonclinical Safety Lead

Animal Compliance Specialist

Finance & Administrative Support Specialist

Manager or Senior Manager - Credits, Grants, and Incentives (AMCS)

Head, AIRx Biologics Discovery

Account Specialist

Engineering Specialist (DevOps) Lead

Executive Director, AIRx Program Lead: Biologics

Roving Recertification Specialist

Nurse Care Manager Brookline 40 hour

Archive Senior Specialist, Global Quality Systems and Compliance (Contract)

Senior Manager, Mutual Fund Tax

GMP Supply Chain Sr. Specialist - Planner/Buyer (contract) 29680

Tax Manager/Tax Senior Manager, Real Estate

Senior Environmental Compliance Specialist

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Has a good understanding of stability requirements per ICH and experience in stability protocol management.

Collaborate with internal and external business partners to resolve quality issues to ensure compliant solutions in support of QA Analytical function.

Experience working with Contract Manufacturing Organizations (CMOs)/Contract Testing Organization (CTOs).

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