Job Description
Description:
HS Diploma Required, Degree preferred
Pharmaceutical or Biotech GMP experience and Supplier Quality
MUST have experience in review and release of GMP batch documentation (a minimum of 2 years of work experience) in the pharma/biotech industries.
This role is responsible for the review and approval of GMP documentation to ensure
compliance in operational areas. Through their fundamental knowledge, assists
manufacturing associates by providing Quality Assurance support for operational
areas involved in the execution of GMP-related activities. Participates in deviations
and root cause investigations. Focused responsibilities include batch record review,
and review of QA Operations related SOPs to meet local, Global and Regulatory
requirements.
- Responsible for the review and approval of cGMP documentation against
Standard Operating Procedures in order to ensure compliance in
Manufacturing processes.
- Raise deviations as needed in order to capture potential impacts to product
quality.
- Revise or review standard operating procedures and submit procedural
changes as needed to meet local, Global and Regulatory requirements.
- Co-represent QA in meetings or on project teams, learning decision making
as a QA representative conferring with senior staff.
- Participates in deviations and root cause investigations.
- Identify areas of non-conformance. Complete minor deviations and support
root cause investigations.
- Perform other duties as assigned.
Required Skills - Effective interpersonal communication. Must have effective verbal and written communication skills. Effective organizational skills and ability to plan and suggest resolutions to technical problems. Ability to handle multiple tasks concurrently and complete tasks in a timely manner. TrackWise, SAP, Excel.
Company Description
We focus exclusively on Life Sciences—Nothing Else!!!.
From our inception, we’ve maintained a singular focus on working with Life Science companies and the industry’s leading businesses. We leverage our experienced, customer-facing team, vast network of 90,000+ Life Sciences professionals, and relationship-first approach to become your trusted advisor and empower you to achieve your goals and future jobs. We’ll work closely with you to listen to your needs, consult you on the most strategic solution, and partner with you to deliver that solution. So, contact us today, stop settling for subpar talent and instead partner with the industry experts and focus more on what you do best: growing your career in an effort to improve quality of life for communities around the world.
We focus exclusively on Life Sciences—Nothing Else!!!.\r\n\r\nFrom our inception, we’ve maintained a singular focus on working with Life Science companies and the industry’s leading businesses. We leverage our experienced, customer-facing team, vast network of 90,000+ Life Sciences professionals, and relationship-first approach to become your trusted advisor and empower you to achieve your goals and future jobs. We’ll work closely with you to listen to your needs, consult you on the most strategic solution, and partner with you to deliver that solution. So, contact us today, stop settling for subpar talent and instead partner with the industry experts and focus more on what you do best: growing your career in an effort to improve quality of life for communities around the world.