95 QA Manager/Senior Manager Jobs in Rockville, MD
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QA Manager/Senior Manager
$112k-137k (estimate)
Full Time | Ambulatory Healthcare Services
1 Week Ago
Green Key Resources is Hiring a QA Manager/Senior Manager Near Rockville, MD
Duties And Responsibilities
- Works closely with Manufacturing regarding product quality planning, design and improvements to ensure Quality is built into manufacturing processes.
- Supports Internal audits and external vendor audits including leading audits and providing the required reports and documentation.
- Performs change control assessments to Quality Systems including document management, change control and CAPA.
- Approves Deviations and CAPAs and ensure all deviations/change controls from established procedures are appropriately documented and investigated to determine and address the root cause.
- Acts as Quality Subject Matter expert and represents Quality in internal and vendor meetings.
- Collaborates with manufacturing, clinical and regulatory groups to ensure site quality.
- Manages the QA review of Batch Records
- Manages SOP review process and assists in identifying gaps.
- Communicates changes in regulations and practices to the organization effectively and in a timely manner and aids in the development of plans to address these changes.
- Interacts with Regulatory Affairs, and Manufacturing to ensure that regulatory submissions meet domestic and international standards and regulatory requirements.
- Other Duties as assigned.
- A minimum of Bachelors degree in a scientific discipline
- A minimum of 5 years Quality Assurance Experience
- A minimum of 3 years of experience in a Quality Assurance management role
- Demonstrated mastery/understanding of Quality Systems and Quality controls.
- Detailed working knowledge of cGxP requirements and current FDA regulations.
- Experience in the preparation of IND and BLA applications
- Strong interpersonal skills: team building, consensus building, and conflict resolution
- Well organized and detail oriented with strong verbal and written communication skills.
Job Summary
JOB TYPE
Full Time
INDUSTRY
Ambulatory Healthcare Services
SALARY
$112k-137k (estimate)
POST DATE
06/21/2024
EXPIRATION DATE
08/06/2024
WEBSITE
greenkeyllc.com
HEADQUARTERS
POTOMAC, MD
SIZE
500 - 1,000
FOUNDED
2004
CEO
CHELSEA MURPHY
REVENUE
<$5M
INDUSTRY
Ambulatory Healthcare Services
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