14 Quality Assurance Manager, Biopharma (JP10327) Jobs in Cambridge, MA
SORT BY
C
E
B
3
3
A
K
B
A
L
A
M
V
C
Quality Assurance Manager, Biopharma (JP10327)
$118k-147k (estimate)
Full Time | Business Services
5 Months Ago
3 Key Consulting is Hiring a Quality Assurance Manager, Biopharma (JP10327) Near Cambridge, MA
Job Title: Quality Assurance Manager, Biopharma (JP10327)Location: Cambridge, MA. Employment Type: ContractBusiness Unit: Combination Product Operations Quality CareDuration: 6 months with likely extensionsPosting Date: 06/09/223 Key Consulting is hiring a Quality Assurance Manager for a consulting engagement with our direct client, a leading global biopharmaceutical company.Job Description:This role provides quality oversight with regards to the development and lifecycle management of test and inspection methods and fulfillment of regulatory commitments. Potential scope of products with regards to test and inspection methods includes a wide range of devices, raw material components, and constituent parts, such as; needle protection systems, fluid transfer devices, pen injectors, automatic pen injectors, and micro-infuser delivery pump systems. The qualified candidate will both lead and/or support technical teams to ensure successful method development or remediation and/or fulfillment of regulatory commitments, provide quality oversight to one or more cross-functional teams to utilize technologies and methodologies that support short-cycle robust development, accelerated compliance efforts, and/or remediation/improvement opportunities. The Quality Assurance Manager will also provide Quality oversight of quality records such as Deviations, CAPAs, Change controls and review/approval of physical test methods documents. Responsibilities include:
Phone screening followed by in-person interview.We invite qualified candidates to send your resume to resumes@3keyconsulting.com. If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.
- Work cross-functionally and globally with individuals and project teams within Final Product Technologies Quality and the Final Product Technologies Engineering groups and their stakeholders in Marketing, Operations, and Development
- Ensure compliance to design controls and fulfillment of user needs during test or inspection method development or design changes, including proper and compliant integration of different subsystems as required.
- Provide quality oversight and guidance regarding the development of process control plans and implementation of process improvements/changes.
- Work with cross-functional teams to develop, qualify, and transfer physical test or inspection methods.
- Provide comprehensive quality guidance and advice to counterparts and stakeholders.
- Provide Quality oversight of quality records such as Deviations, CAPAs, Change controls and review/approval of physical test methods documents.
- BS or BE in Engineering and previous experience in the medical device and/or pharmaceutical industries
- 8 years current experience with engineering processes/procedures and quality tools. - Major contributions to or the leadership of projects from development through the 510k and PMA approval process.
- Experience with material & test specs generation, protocol & report writing, process & test development, prototyping, design verification/validation, DOE/SPC process optimization & validation (IQ, OQ, PQ), P/DFMEA.
- Product design/development (design control) from concept to post product launch for Europe (EMEA/CE Mark) & US (FDA/PMA/510k) submissions.
- Experience in test or inspection method design and development - Small scale device assembly and/or benchtop testing experience.
- Experience with Automated Test Equipment (ATE). – Experience with regard to Measurement Systems Analysis/GRR principles, including study design/execution/troubleshooting
- Experience with Deviations, CAPAs, Change controls and document review/approval
- Strong critical thinking, problem solving, risk assessment, and risk management skills.
- Must be capable of working on multiple projects in a deadline driven environment.
- Project management skills
- Experienced with processes involved in test, inspection for a wide range of devices, raw material components, constituent parts (needle protection systems, fluid transfer devices, pen injectors, automatic pen injectors, and micro-infuser delivery pump systems.
- Experience with quality records
- Experience with physical method validation, qualification and transfers
- Work with a cross functional team to ensure compliance to design controls and fulfillment of user needs
- Work with cross-functional teams to develop, qualify, and transfer physical test or inspection methods
- Review and approve physical test method design documents, validation, qualification and transfer documents
- Review and approve quality records (deviations, CAPA/EVs, change controls)
- Lead problem solving and lean improvement projects
Phone screening followed by in-person interview.We invite qualified candidates to send your resume to resumes@3keyconsulting.com. If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.
Job Summary
JOB TYPE
Full Time
INDUSTRY
Business Services
SALARY
$118k-147k (estimate)
POST DATE
12/13/2023
EXPIRATION DATE
05/04/2024
WEBSITE
3keyconsulting.com
HEADQUARTERS
WEST HILLS, CA
SIZE
100 - 200
FOUNDED
2009
TYPE
Private
REVENUE
$50M - $200M
INDUSTRY
Business Services
Related Companies
Show more
Similar Jobs
Popular Articles
Top 10 Things to Avoid Putting on a Job Application
Read Article
How to Describe Your Education in a Resume
Read Article
How to Write a Memorable Cover Letter in 5 Ways
Read Article
4 Personal Finance Tips to Make During Job Transition
Read Article
4 Best Camera Setups for Interview
Read Article
Keeping a Job Search Journal: 9 Types of Journaling You Can Do
Read Article
