![Axelon](https://media.trabajo.org/img/noimg.jpg)
QA lead technical operations
1 month ago
Job Description: QA Lead Technical Operations, Projects
Onsite, Devens location
Work Schedule: Mon - Fri, First shift (8:30AM - 5PM)
Job Description/ Responsibilities:
- Provides Quality Assurance (QA) support to Devens Site and reporting Manger through quality review and
pproval of Investigations and Corrective Actions.
- Decision making of non-conformance through a deep understanding of Quality Systems Regulatory expectations
- Reviews and approves Quality, Quality Control, Validation and Automation related documents
- Review and approves Standard Operating Procedures (SOPs).
- Review and approval of Validation related documentation such as risk assessments, protocols and test scripts and
summary reports.
- Review and approval of change proposals as well as associated deliverables, ensuring the change deliverables meet
external regulatory and internal WWQC guidelines and requirements.
- Ability to coach across different departments within the subject matter of Investigations, CAPAs, general risk
ssessments and Validation.
- Ability to self-manage and prioritize work across multiple competing deliverables, in a remote working
environment
- Able to interpret complicated data and make sound decisions, Independently
This position will regularly interact with:
Reporting Manager
Sometimes will interact with departments listed below:
Quality Control
Manufacturing Operations
Manufacturing Engineering
Manufacturing Science and Technology (MS&T)
Validation
Site Engineering
Digital Plant
Education, Experience, and Qualifications:
- Knowledge of science generally attained through studies resulting in a B.S; in Biological science, Engineering,
biochemistry, or related discipline, or its equivalent is preferred.
- Advanced Level of relevant experience in a GMP, GCP, or GXP with at least 8 years focused on product
quality. Preferred Active member of ASQ or ISPE.
- Prior experience of QC equipment Qualification and some project management experience
- Knowledge of biotech, bulk drug substance or finished product manufacturing, medical device analytical testing is
highly desirable.
- Extensive knowledge of US and EU cGMP regulations and guidance and GAMP 5.
- Knowledge of electronic systems including any of the following: SAP, LIMS, TrackWise, Veeva Vault and electronic
or paper based batch records desirable.
- Excellent Technical writing and oral communication skills are required.
- Background in problem solving
- Knowledge of Data integrity principles
- Proven attention to details
- Comfortable working in an FDA regulated environment.
Contractor must be able to come onsite Monday through Friday - 1st shift
dditional Job Requirements:
None
-
QA lead technical operations
1 month ago
Devens, United States Integrated Resources Full timeJob Description: QA Lead Technical Operations, Projects Onsite, Devens location Work Schedule: Mon - Fri, First shift (8:30AM - 5PM) Job Description/ Responsibilities: Provides Quality Assurance (QA) support to Devens Site and reporting Manger through quality review and pproval of Investigations and Corrective Actions. Decision making of non-conformance...
-
QA lead technical operations
1 month ago
Devens, United States Mindlance Full timeJob Description: QA Lead Technical Operations, Projects Onsite, Devens location Work Schedule: Mon - Fri, First shift (8:30AM - 5PM) Job Description/ Responsibilities: Provides Quality Assurance (QA) support to Devens Site and reporting Manger through quality review and approval of Investigations and Corrective Actions. Decision making of non-conformance...
-
QA lead technical operations(GMP and CAPA)
1 month ago
devens, United States Joulé Full timeJob Title:(GMP & CAPA)QA lead technical operationsLocation: Devens, MAHours/Schedule: Mon - Fri, First shift (8:30AM - 5PM)Type: ContractResponsibilitiesProvides Quality Assurance (QA) s...
-
QA Lead Technical Operations, Projects
1 day ago
Devens, United States Omni Inclusive Full timeQA Lead Technical Operations, Projects Onsite, Devens location Work Schedule: Mon - Fri, First shift (8:30AM - 5PM) Job Description/ Responsibilities: • Provides Quality Assurance (QA) support to Devens Site and reporting Manger through quality review and approval of Investigations and Corrective Actions. • Decision making of non-conformance through a...
-
QA Lead Technical Operations, Projects
2 months ago
Devens, United States Sunrise System Inc Full timeJob Title: QA Lead Technical Operations, Projects Job ID: 24-02756 location: Devens, MA Duration: 03 Months contract on W2 This position will regularly interact with: Reporting Manager Sometimes will interact with departments listed below: Quality Control Manufacturing Operations Manufacturing Engineering ...
-
QA lead technical operations(GMP and CAPA)
1 month ago
Devens, United States System One Holdings, LLC Full timeJob Title:(GMP & CAPA)QA lead technical operations Location: Devens, MA Hours/Schedule: Mon - Fri, First shift (8:30AM - 5PM) Type: Contract Responsibilities Provides Quality Assurance (QA) support to Devens Site and reporting Manger through quality review and approval of Investigations and Corrective Actions. Decision making of non-conformance through a...
-
QA lead technical operations(GMP and CAPA)
1 month ago
Devens, United States System One Full timeJob Title:(GMP & CAPA)QA lead technical operations Location: Devens, MA Hours/Schedule: Mon - Fri, First shift (8:30AM - 5PM) Type: Contract Responsibilities Provides Quality Assurance (QA) support to Devens Site and reporting Manger through quality review and approval of Investigations and Corrective Actions. Decision making of non-conformance through a...
-
Quality - QA lead technical operations
4 weeks ago
Devens, United States HonorVet Technologies Full timeOnsite Work Schedule: Mon - Fri, First shift (8:30AM - 5PM) Responsibilities: Provides Quality Assurance (QA) support to Devens Site and reporting Manager through quality review and approval of Investigations and Corrective Actions. Decision making of non-conformance through a deep understanding of Quality Systems Regulatory expectations. Reviews and...
-
Devens, United States EcoPlanet Green Operations GmbH Full timeJob Description: Major Duties and Responsibilities • Create and maintain master data/static data in SampleManager LIMS (SMLIMS) by executing the appropriate change management process to support laboratory testing activities and to ensure business, project and/or investigation/CAPA timelines are met. • Test changes/enhancements through dry runs and...
-
Senior Manager
2 months ago
Devens, United States Commonwealth Fusion Systems Full timeCommonwealth Fusion Systems (CFS) has the fastest, lowest cost path to commercial fusion energy. CFS collaborates with MIT to leverage decades of research combined with groundbreaking new high-temperature superconducting (HTS) magnet technology. HTS magnets will enable compact fusion power plants that can be constructed faster and at lower cost. Our mission...
-
Director, Quality Operations
3 weeks ago
Devens, United States Veranova L P Full timeJob DescriptionJob DescriptionCompany DescriptionVeranova is a global leader in the development and manufacturing of complex active pharmaceutical ingredients (APIs) for pharma and biotech customers. With deep technical expertise and impressive flexibility, we develop solutions and processes that support and accelerate innovation. Job SummaryThis position...
-
Medical Device Assembler
3 weeks ago
Devens, United States Advantage Technical Full timeAre you ready for a change of pace and looking for a stable career move? Advantage Technical is hiring a Medical Device Assembler for a leading medical device company Start a new career today and enjoy a 4-day work week! That's right; have every Friday off. Monday - Thursday | 2nd shift 345pm to 215 am 10 hour days Requirements for this position include 2...
-
Devens, United States Advent Global Solutions Full timeJob Description: QA Specialist, Incoming Material Disposition Onsite role, Devens site Work Schedule: Monday - Friday, Business Hours * Note there are Two openings for this role* PURPOSE AND SCOPE OF POSITION: The Quality Assurance Incoming Material Disposition Specialist is responsible for supporting the incoming inspection and disposition of incoming...
-
Devens, United States System One Full timeJob Title: QA Specialist, Incoming Material Disposition Location: Devens, MA Hours/Schedule: Monday - Friday, Business Hours Type: Contract Join a global biopharmaceutical company committed to discovering, developing and delivering innovative medicines to patients with serious illnesses Responsibilities Works closely with Supply Chain and Manufacturing with...
-
Med Device assembler
2 days ago
Devens, United States Advantage Technical Full timeShifts Available: 1st Shift: Monday-Thursday, 5:30 AM - 4:00 PM 2nd Shift: Monday-Thursday, 3:45 PM - 2:15 AM 3rd Shift: Friday-Sunday, 6:00 AM - 6:30 PM (Weekend Shift) Job Description: Advantage Technical is seeking dedicated and detail-oriented Cleanroom Assembly Technicians to join our client's team. The successful candidate will be responsible for the...
-
Site Lead
1 week ago
Devens, United States SOS International LLC Full timeOverview * This position is contingent upon contract award * SOSi is currently seeking a Site Lead to assist in contract operations for a large intelligence services program currently focused on the USCENTCOM AOR with CONUS reachback. The Site Lead will work with Regional Managers (RM) and the Program Manager (PM) to resolve PCO/COR identified contract...
-
Laser Operator-Full time
1 month ago
Devens, United States Accumet Engineering Inc Full timeJob DescriptionJob DescriptionJob summaryPrimary responsibilities will include, but not limited to, the set up and running of different (CNC) computer numeric controlled production equipment within the Metals Department. The ability to set appropriate settings and make necessary adjustments; will be a big contribution in completing jobs satisfactorily....
-
Senior Technical Project Manager
7 days ago
Devens, United States Commonwealth Fusion Systems Full timeJob DescriptionCommonwealth Fusion Systems (CFS) has the fastest, lowest cost path to commercial fusion energy.CFS collaborates with MIT to leverage decades of research combined with groundbreaking new high-temperature superconducting (HTS) magnet technology. HTS magnets will enable compact fusion power plants that can be constructed faster and at lower...
-
Site Lead
2 months ago
Devens, United States SOSi Full timeOverview*** This position is contingent upon contract award *** SOSi is currently seeking a Site Lead to assist in contract operations for a large intelligence services program currently focused on the USCENTCOM AOR with CONUS reachback. The Site Lead will work with Regional Managers (RM) and the Program Manager (PM) to resolve PCO/COR identified contract...
-
Lead Manufacturing Engineer
1 week ago
Devens, United States Commonwealth Fusion Systems Full timeCommonwealth Fusion Systems (CFS) has the fastest, lowest cost path to commercial fusion energy.CFS collaborates with MIT to leverage decades of research combined with groundbreaking new high-temperature superconducting (HTS) magnet technology. HTS magnets will enable compact fusion power plants that can be constructed faster and at lower cost. Our mission...