GMP Operational Quality, Senior Specialist
Found in: Resume Library US A2 - 1 week ago
The GMP Operational Quality Senior Specialist works with a high degree of independence to provide QA Analytical support for release and stability program for commercial products. The GMP Operational Quality Specialist 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 release of commercial product as required.
Collaborates 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 oversite of root-cause analysis and product impact assessment for deviation and OOS/OOT investigations. Ensure that appropriate CAPA actions are identified. May approve investigations/CAPAs.
Supports change control assessment, implementation, and closure as needed.
Conducts GMP document review, including procedures, work instructions, specifications, methods, protocols, and reports.
Supports analytical method validation and transfer activities for commercial and clinical products as needed.
Drafts and enforces Quality Agreements between CMOs/Suppliers and Vertex, as needed
Identifies and facilitates continuous improvement efforts
Supports generations and maintenance of Quality Metrics to support process improvement activities as necessary.
Identify and communicate risks and assist with risk mitigation plans as necessary
KNOWLEDGE AND SKILLS:
Knowledge of both the conceptual and practical application of cGMPs in a pharmaceutical setting; in-depth knowledge of global GMP requirements and support of GMP manufacturing and testing.
Strong knowledge of basic analytical techniques in a QC/commercial setting (e.g., HPLC, dissolution, GC, KF, etc.)
Experience working with CMO/CTO’s.
Experience supporting multiple projects/teams, ability to work in a fast-paced environment and meet quality, accuracy and timeliness objectives
Good communication skills (written and verbal) and the ability to communicate cross-functionally to a wide variety of audiences.
Demonstrated ability to work independently to provide QA advice for large, multifaceted projects
Demonstrated ability to evaluate quality matters and make decisions leveraging technical experience and judgement.
Experience in supporting Quality Event Investigations, Root Cause Analysis (RCA) and CAPA implementation.
Experience in assessing Change Controls
Experience with electronic document management systems (e.g., Trackwise, Veeva).
PREFFERED EDUCATION AND EXPERIENCE:
Bachelor's degree in a scientific or allied health field (or equivalent degree) and 5+ years of experience, or the equivalent combination of education and experience.
Advance knowledge of GMP regulations and applicability to duties.
Operational QA experience in analytical or manufacturing setting, interpretation, and application of GMPs and applicable guidelines/guidance’s ex. ICH, USP, etc.
RCA tools/methodology/ technical writing
Facilitation/ problem solving /organizational, planning, etc
Pay Range:
$50-$60/hr
Requisition Disclaimer:
This job posting is for a temporary role with a third-party agency partner on assignment at Vertex Pharmaceuticals (“Vertex”). The individual selected for this role will be offered the role as an employee of a third- party agency partner; compensation, medical benefits, fringe benefits and other terms and conditions of employment shall be presented by the third-party agency partner upon offer. The pay rate range provided is a reasonable estimate of the anticipated compensation range for this job at the time of posting. The actual pay rate will be based on a number of factors, including skills, competencies, experience, location and/or being pursued and other job-related factors permitted by law. In addition, this role will be eligible for overtime pay, in accordance with federal and state requirements
By applying for this position, you agree to the Atrium Terms and Conditions and you direct Atrium to share your application materials, which may include your RESUME/Resume, email address or phone number, with Vertex. For more information on how Vertex handles your personal data related to your job application, please see Vertex’s Agreeing to the Atrium Terms and Conditions, includes permission to use the email address and mobile phone number you provide during the application process or throughout the duration of your prospective or actual employment to notify you of job openings, profiles, articles, news, and other employment-related information, as well as to notify you of special promotions or additional products and services offered by us or our affiliates and partners
(collectively, “Atrium Alerts”). Atrium Alerts may be sent by email, phone, or text message. Your personal information will be safely stored within the Atrium & Vertex databases. Atrium does not sell your personal information to third parties. Text message and data rates may apply. To OPT OUT of text messaging or to modify your communication preferences for Atrium Alerts at any time, please contact Atrium at .
If you do not agree with the Atrium Terms and Conditions, you can still complete your application for this position by emailing your resume to our team at Please include the job title in the subject of your email.
No C2C or Third-Party Vendors
-
GMP QA Operations Senior Specialist
Found in: Resume Library US A2 - 1 week ago
Boston, Massachusetts, United States Vertex Pharmaceuticals Full timeJob Description: The Sr. Specialist GMP QA Operations works with a high degree of independence, while providing oversight of the development, implementation, and maintenance of relevant quality initiatives in support of their function. The Senior Specialist completes work in a resourceful, self-sufficient manner and is able to design alternative approaches...
-
Sr GMP Operations Specialist
1 week ago
Boston, United States Connexion Systems & Engineering Full timeJob DescriptionJob Description Job Title: GMP Operational Quality Sr Specialist Location: Hybrid Boston Salary range: $50-60/hr Nice to have qualifications: · Provides QA review of the GMP data in support of release of commercial product as required. · Collaborates with internal and external business partners to resolve quality issues to ensure compliant...
-
Senior Specialist, Site Quality Assurance Operations
Found in: Resume Library US A2 - 7 days ago
Cambridge, Massachusetts, United States Editas Medicine Full timeAt Editas, we’re driven by a collective purpose, to bring transformative and life changing therapies to people living with serious diseases with the greatest unmet needs. This fuels our drive to excel in scientific innovation, allowing us to harness the power and potential of CRISPR/Cas9 and CRISPR/Cpf1 (Cas12a) gene editing. We believe our people are at...
-
Commercial GMP Quality Assurance Specialist
Found in: Resume Library US A2 - 7 days ago
Boston, Massachusetts, United States Vertex Pharmaceuticals Full timeJob Description: JOB DESCRIPTION: Sound understanding of GMP principles and their application to product quality and compliance, supporting commercial paper-based Executed Batch Record (EBR) and disposition of Drug Substance (DS)/ Active Pharmaceutical Ingredient (API), Spray Dried Dispersion (SDD), and/ or Drug Product (DP). The ideal candidate will have a...
-
Principal Specialist, Quality Assurance Operations
Found in: Resume Library US A2 - 7 days ago
Cambridge, Massachusetts, United States Editas Medicine Full timeAt Editas, we’re driven by a collective purpose, to bring transformative and life changing therapies to people living with serious diseases with the greatest unmet needs. This fuels our drive to excel in scientific innovation, allowing us to harness the power and potential of CRISPR/Cas9 and CRISPR/Cpf1 (Cas12a) gene editing. We believe our people are at...
-
Commercial Gmp Quality Assurance Specialist
6 days ago
Boston, United States Vertex Pharmaceuticals Full time**Job Description**: **JOB DESCRIPTION**: **KEY RESPONSIBILITIES**: May include, but are not limited to, the following: - Identifies and supports quality investigations /deviations and reviews corrective action plans for adequacy and compliance. This includes root cause analysis and product impact assessments for investigations resulting from deviations and...
-
Quality Assurance Sr. Specialist
2 days ago
Boston, United States Katalyst Healthcares and Life Sciences Full timeDescription:seeking a Quality Assurance Sr. Specialist for real time on the floor quality oversight and lot disposition of Small Molecule GMP manufacturing facility at Moderna Inc. This position will be based in our cGMP Small Molecule Manufacturing site in Cambridge, MA. The individual in this role will be part of a cohesive team responsible for supporting...
-
Pharmaceutical Manufacturing and Compliance Specialist
Found in: Resume Library US A2 - 1 week ago
Boston, Massachusetts, United States Vertex Pharmaceuticals Full timeJob Description: General Summary: The Specialist, Manufacturing Technical Investigations and Analytics (MTIA) will work collaboratively across departments to ensure a state of compliance exists within Vertex Manufacturing Center (VMC), manufacturing, facilities and warehouse operations. This position will facilitate improvements to documentation,...
-
Quality Systems Supervisor, Site Quality Assurance Operations
Found in: Resume Library US A2 - 2 weeks ago
Waltham, Massachusetts, United States Editas Medicine Full timeAt Editas, we’re driven by a collective purpose, to bring transformative and life changing therapies to people living with serious diseases with the greatest unmet needs. This fuels our drive to excel in scientific innovation, allowing us to harness the power and potential of CRISPR/Cas9 and CRISPR/Cpf1 (Cas12a) gene editing. We believe our people are at...
-
Quality Systems Senior Specialist
1 week ago
Boston, United States Vertex Pharmaceuticals Full timeJob Description: The Quality Systems Sr. Specialist is an experienced technical resource in the principles and application of quality systems and compliance. The Quality Systems Sr. Specialist coordinates or executes activities on projects and takes a role in the execution and improvement of processes. Key Responsibilities: The responsibilities of this...
-
Boston, United States CareerBuilder Full timeManager/ Sr. Manager, Quality Assurance Operations (QA for QC) HilleVax is a clinical-stage biopharmaceutical company focused on developing and commercializing novel vaccines. Our initial program, HIL-214, is a virus-like particle (VLP) based vaccine candidate for the prevention of moderate-to-severe acute gastroenteritis (AGE) caused by norovirus infection....
-
Quality & Patient Safety Specialist
Found in: Resume Library US A2 - 2 weeks ago
Boston, Massachusetts, United States Jobvous Staffing Solutions, LLC Full timeJob DescriptionPOSITION SUMMARY: The Quality & Patient Safety Specialist plays a role in supporting the development, implementation, management and sustainment of an organization-wide system of quality and safety. Working with the Quality & Patient Safety team and organizational cross-functional teams, the Quality & Patient Safety specialist will support...
-
Quality Assurance Change Specialist
Found in: Resume Library US A2 - 7 days ago
Tewksbury, Massachusetts, United States Cambridge Isotope Laboratories, Inc. Full timeCambridge Isotope Laboratories, Inc. (CIL) is searching for a Quality Assurance Change Specialist based onsite in our Tewksbury, MA facility. CIL is the global leading company in a highly technical, extremely fast-growing industry and is a critical supplier to several scientific and high technology markets. CIL's growing customer base spans academia,...
-
Boston, United States HilleVax, Inc. Full timeHilleVax is a clinical-stage biopharmaceutical company focused on developing and commercializing novel vaccines. Our initial program, HIL-214, is a virus-like particle (VLP) based vaccine candidate for the prevention of moderate-to-severe acute gastroenteritis (AGE) caused by norovirus infection. It is estimated that norovirus causes nearly 700 million cases...
-
Quality Assurance Specialist I
Found in: Resume Library US A2 - 7 days ago
Tewksbury, Massachusetts, United States Cambridge Isotope Laboratories, Inc. Full timeCambridge Isotope Laboratories (CIL) has an outstanding opportunity for a Quality Assurance Specialist I to join the team responsible for the quality of several new and existing active pharmaceutical ingredients (APIs) and medical device components based onsite in our Tewksbury, MA location. CIL is the global leading company in a highly technical,...
-
Senior Communications Specialist
Found in: Resume Library US A2 - 13 hours ago
Boston, Massachusetts, United States Tufts University Full timeOverview: The mission of the Human Nutrition Research Center on Aging at Tufts University (HNRCA) is to promote healthy aging through nutrition science to empower people seeking to enjoy long, active, and independent lives. HNRCA’s scientists examine how nutrition and physical activity play a role in the prevention of the major chronic degenerative...
-
Boston, United States RPMGlobal Full timeSenior or Lead Bank/Treasury Operations Specialist Location: Boston Job Code: 390 # of openings: 2 Description The Federal Home Loan Bank of Boston is a leading provider of wholesale funding for housing and community finance in New England serving more than 420 financial institutions across the region. The Federal Home Loan Bank of Boston is committed to...
-
Quality Control Senior Associate
Found in: Resume Library US A2 - 1 week ago
Boston, Massachusetts, United States Vertex Pharmaceuticals Full timeJob Description: The Vertex Cell and Gene Therapy (VCGT) Type 1 Diabetes (T1D) Quality Control (QC) team is responsible for the testing of samples and associated workflows within our stem-cell based T1D program. VCGT T1D QC carries out all activities under Good Manufacturing Practices (GMP) guidelines, including the running of tests and reporting of test...
-
MRI Quality Specialist
Found in: Lensa US P 2 C2 - 2 weeks ago
Boston, United States CareerBuilder Full timePOSITION SUMMARY: The MRI Quality Specialist is an integral member of the MRI department at Boston Medical Center. This technologist functions as a facilitator, coordinator, investigator, educator, quality specialist and MRI technologist. Working closely with the Manager of MRI services, the MRI Quality Specialist anticipates problems before they arise and...
-
Boston, United States Vertex Pharmaceuticals Full timeJob Description: General Summary: The Specialist, Manufacturing Technical Investigations and Analytics (MTIA) will work collaboratively across departments to ensure a state of compliance exists within Vertex Manufacturing Center (VMC), manufacturing, facilities and warehouse operations. This position will facilitate improvements to documentation,...
