Senior Quality Assurance Specialist – Operational Quality, Materials Management (Contract) 24004
Job Description:
The Senior Operational Area Quality Specialist - Operational Quality, Materials Management will provide QA support for materials management including the release of incoming raw materials and consumables for internal manufacturing programs at VCGT.This role will support both manufacturing and analytical laboratory operations including review of incoming data, GMP documentation, QC release testing and other quality systems documentation as needed in support of materials management.
Key Duties and Responsibilities:
- Provides QA support overseeing the management of incoming raw materials and consumables for internal manufactured products
- Reviews GMP documentation for incoming raw materials and consumables for internal manufactured products
- Performs final review of executed GMP documentation for the management of materials and determines acceptability by using standard operating procedures.
- Ensures presence and acceptability of all required documentation prior to the release of raw materials and consumables
- Supports the day-to-day management of incoming raw materials and consumables release process
- Provides QA support in the management of SCARs assisting in determining impact to incoming raw materials and consumables as well as supporting vendor investigations
- Maintains and archive files such that documents are readily available and easily retrievable
- Assists department with weekly/monthly/quarterly Quality System data review metrics and reporting pertaining to materials management
- Communicates proactively with internal and external partners as well as with management
- Escalates critical and major findings to Quality management
Knowledge and Skills:
- Knowledge of cGMP's in a pharmaceutical setting
- Ability to collaborate effectively within a team
- Ability to work in a fast-paced environment, manage priorities and maintain timelines for multiple projects
- Strong attention to detail
- Effective communication skills, both verbal and written
- Demonstrated success by independently leading cross-functional teams
Education and Experience:
- Bachelor's degree in scientific or allied health field (or equivalent degree)
- Typically requires 3-5 years of experience, or the equivalent combination of education and experience
- Experience in providing QA support and oversight of GMP manufacturing operations including materials management
- Experience with successfully leading SCARs with external vendors
- Experience with network-based applications such as Oracle, LIMS and Veeva
- Experience working with cross-functional teams
Pay Range:
$55-65/hr
Requisition Disclaimer:
This job posting is for a temporary role with a third-party agency partner on assignment at Vertex Pharmaceuticals (“Vertex”). The individual selected for this role will be offered the role as an employee of a third- party agency partner; compensation, medical benefits, fringe benefits and other terms and conditions of employment shall be presented by the third-party agency partner upon offer.The pay rate range provided is a reasonable estimate of the anticipated compensation range for this job at the time of posting. The actual pay rate will be based on a number of factors, including skills, competencies, experience, location and/or being pursued and other job-related factors permitted by law.
In addition, this role will be eligible for overtime pay, in accordance with federal and state requirements
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No C2C or Third-Party Vendors