Sr GMP Operations Specialist

4 weeks ago

Boston, United States Connexion Systems & Engineering Full time

Job 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 solutions in support of QA Analytical function.

· Supports change control assessment, implementation, and closure as needed.

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

· Strong knowledge of basic analytical techniques in a QC/commercial setting (e.g., HPLC, dissolution, GC, KF, etc.)

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

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

· Experience in assessing Change Controls

Job Description

The GMP Operational Quality 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 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 3-4 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

Company DescriptionConnexion Systems & Engineering is a full-service staffing firm, whose mission is to provide "best in class" staffing services to our clients and job seekers alike. We strive to achieve excellence in staffing, job placement and recruiting services, while treating our clients, employees, and candidates with the professionalism and respect they deserve.Company DescriptionConnexion Systems & Engineering is a full-service staffing firm, whose mission is to provide "best in class" staffing services to our clients and job seekers alike. We strive to achieve excellence in staffing, job placement and recruiting services, while treating our clients, employees, and candidates with the professionalism and respect they deserve.

#J-18808-Ljbffr

  • Senior Specialist, GMP Operational Quality

    1 month ago

    Boston, United States Vertex Pharmaceuticals, Inc Full time

    Job Description General Summary: The Senior Quality Specialist is recognized as an expert internally in the principles and application of quality assurance and compliance. The Senior Quality Specialist coordinates GMP activities in support of clinical and commercial Drug Product manufacturing and disposition. * This is an on-site position on the 2nd...

  • Senior Specialist, GMP Operational Quality

    3 weeks ago

    Boston, United States Vertex Pharmaceuticals, Inc Full time

    Job Description General Summary: The Senior Quality Specialist is recognized as an expert internally in the principles and application of quality assurance and compliance. The Senior Quality Specialist coordinates GMP activities in support of clinical and commercial Drug Product manufacturing and disposition. * This is an on-site position on the 2nd...

  • Quality Assurance Sr. Specialist

    3 weeks ago

    Boston, United States Katalyst Healthcares And Life Sciences Full time

    Description: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...

  • Senior Specialist, Quality GMP

    4 weeks ago

    Boston, Massachusetts, United States Entrada Therapeutics Full time

    The OrganizationWhat's happening at Entrada Therapeutics? Entrada is a clinical-stage biopharmaceutical company aiming to transform the lives of patients by establishing a new class of medicines that engage intracellular targets that have long been considered inaccessible.Our Endosomal Escape Vehicle (EEVTM)-therapeutics are designed to enable the efficient...

  • Senior Specialist, Quality GMP

    4 weeks ago

    Boston, Massachusetts, United States Entrada Therapeutics Full time

    The OrganizationWhat's happening at Entrada Therapeutics? Entrada is a clinical-stage biopharmaceutical company aiming to transform the lives of patients by establishing a new class of medicines that engage intracellular targets that have long been considered inaccessible.Our Endosomal Escape Vehicle (EEVTM)-therapeutics are designed to enable the efficient...

  • Senior Specialist, Quality GMP

    4 weeks ago

    Boston, United States Entrada Therapeutics Full time

    The Organization What's happening at Entrada Therapeutics? Entrada is a clinical-stage biopharmaceutical company aiming to transform the lives of patients by establishing a new class of medicines that engage intracellular targets that have long been considered inaccessible. Our Endosomal Escape Vehicle (EEV™)-therapeutics are designed to enable the...

  • Senior Specialist, Quality GMP

    3 weeks ago

    Boston, United States Entrada Therapeutics Full time

    The Organization What's happening at Entrada Therapeutics? Entrada is a clinical-stage biopharmaceutical company aiming to transform the lives of patients by establishing a new class of medicines that engage intracellular targets that have long been considered inaccessible. Our Endosomal Escape Vehicle (EEV™)-therapeutics are designed to enable the...

  • Senior Specialist, Quality GMP

    1 week ago

    Boston, United States Entrada Therapeutics Full time

    The Organization What's happening at Entrada Therapeutics? Entrada is a clinical-stage biopharmaceutical company aiming to transform the lives of patients by establishing a new class of medicines that engage intracellular targets that have long been considered inaccessible. Our Endosomal Escape Vehicle (EEV™)-therapeutics are designed to enable the...

  • Sr. Specialist, Manufacturing Operations

    1 month ago

    Boston, United States Vertex Pharmaceuticals, Inc Full time

    Job Description General Summary: Vertex Pharmaceuticals Inc. has established a state-of-the-art GMP manufacturing facility in Boston less than a mile from the Corporate Headquarters in the Seaport District. This GMP facility is a keystone to delivering our strategy of bringing transformative medicines to patients in need, from clinical development to...

  • Sr. Specialist, Manufacturing Operations

    4 weeks ago

    Boston, United States Vertex Pharmaceuticals, Inc Full time

    Job Description General Summary: Vertex Pharmaceuticals Inc. has established a state-of-the-art GMP manufacturing facility in Boston less than a mile from the Corporate Headquarters in the Seaport District. This GMP facility is a keystone to delivering our strategy of bringing transformative medicines to patients in need, from clinical development to...

  • Sample Coordinator, GMP Operations

    3 weeks ago

    Boston, United States HireMinds Full time

    Sample Coordinator, GMP Technical OperationsBoston, MAOur client is a clinical-stage biopharmaceutical company focused on developing and commercializing novel vaccines. The ideal candidate for this role will own the end-to-end sample shipment process from CDMO sample shipment delivery to sample shipment receipt at the CTLs. This individual will resolve all...

  • Sample Coordinator, GMP Operations

    4 weeks ago

    Boston, United States HireMinds Full time

    Sample Coordinator, GMP Technical OperationsBoston, MAOur client is a clinical-stage biopharmaceutical company focused on developing and commercializing novel vaccines. The ideal candidate for this role will own the end-to-end sample shipment process from CDMO sample shipment delivery to sample shipment receipt at the CTLs. This individual will resolve all...

  • Gmp Cleaner

    1 week ago

    Boston, United States C&W Services Full time

    **Job Title** GMP Cleaner **Job Description Summary** This position requires strict adherence to current Good Manufacturing Practices (cGMPs), established cleaning practices and procedures, and compliance with quality standards and regulations. The purpose of the sanitization program is to control microbial contamination and to serve as a corrective...

  • Gmp Cleaner

    2 weeks ago

    Boston, United States C&W Services Full time

    **Job Title** GMP Cleaner **Job Description Summary** This position requires strict adherence to current Good Manufacturing Practices (cGMPs), established cleaning practices and procedures, and compliance with quality standards and regulations. The purpose of the sanitization program is to control microbial contamination and to serve as a corrective...

  • Gmp Cleaner

    1 week ago

    Boston, Massachusetts, United States C&W Services Full time

    Job TitleGMP CleanerJob Description SummaryThis position requires strict adherence to current Good Manufacturing Practices (cGMPs), established cleaning practices and procedures, and compliance with quality standards and regulations. The purpose of the sanitization program is to control microbial contamination and to serve as a corrective action for the loss...

  • Manager, GMP Operational Quality

    5 days ago

    Boston, United States Vertex Pharmaceuticals Full time

    Manager, GMP Operational Quality (Hybrid) page is loaded Manager, GMP Operational Quality (Hybrid) Apply locations Boston, MA time type Full time posted on Posted 11 Days Ago job requisition id REQ-22189 Job Description GENERAL POSITION SUMMARY: The Quality Manager is recognized as an expert in the principles and application of quality and regulatory...

  • Senior Specialist, Quality Assurance

    3 weeks ago

    Boston, United States OSI Full time

    Sr Specialist, Quality Assurance Position Summary The Sr Specialist Quality Assurance will be responsible for quality review of production and testing of clinical trial materials at external manufacturing site. Routine activities including review and approval of master batch records, executed batch records, analytical testing protocols, methods, reports and...

  • Senior Specialist, Quality Assurance

    1 week ago

    Boston, United States PepGen Full time

    Sr Specialist, Quality AssurancePosition Summary The Sr Specialist Quality Assurance will be responsible for quality review of production and testing of clinical trial materials at external manufacturing site. Routine activities including review and approval of master batch records, executed batch records, analytical testing protocols, methods, reports and...

  • Senior Specialist, Quality Assurance

    4 weeks ago

    Boston, United States PepGen Full time

    Job DescriptionJob DescriptionSr Specialist, Quality AssurancePosition Summary The Sr Specialist Quality Assurance will be responsible for quality review of production and testing of clinical trial materials at external manufacturing site. Routine activities including review and approval of master batch records, executed batch records, analytical testing...

  • Senior Specialist, Quality Assurance

    1 month ago

    Boston, United States PepGen Full time

    Job DescriptionJob DescriptionSr Specialist, Quality AssurancePosition Summary The Sr Specialist Quality Assurance will be responsible for quality review of production and testing of clinical trial materials at external manufacturing site. Routine activities including review and approval of master batch records, executed batch records, analytical testing...