Quality Assurance Specialist
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$30.00 - $33.88 /Hour
QUALITY ASSURANCE SPECIALIST
This position is responsible for managing the timely release of incoming raw materials and consumables and for the assessment and closure of deviation investigations to ensure timely release of manufactured clinical products. This position is responsible for performing SAP transactions for material movements and disposition. Responsibilities include and may not be limited to:
The review and approval of raw material specifications, raw material and test method qualification and transfer documents, participation in vendor audits, preparation and review of quality agreements, vendor risk assessments and new vendor approvals.
This position will also prepare quality metrics related to raw material release and deviation investigations for the routine quality council meetings.
This position will also manage deviation investigations related to raw materials, laboratory testing, GMP manufacturing operations and facility controls.
This will involve conducting routine cross-functional investigation review meetings to support the lead investigators and to ensure the timely deviation closure.
The position will ensure that thorough investigations are conducted in accordance with SOPs and appropriate corrective and preventive actions are assigned to address the root cause with appropriate assessment of impact to product quality.
This position will be involved in authoring, review and approval of Standard Operating Procedures (SOPs) and other GMP documents.
This role will also provide quality representation at raw material planning meetings for new project launches and be part of the risk assessment teams.
This position requires ability to work independently with strong attention to detail, ability to drive performance and meet metric commitments and ability to make informed decisions that impact material or product release.
The position requires ability to be innovative, and help ensure high standards of quality and compliance are maintained at the site.
At minimum, a B.S. degree in a scientific discipline.
A minimum of 7 years of related experience in the pharmaceutical or biologics industry with at least three years prior experience in Quality Assurance.
An extensive knowledge and understanding of FDA, EU and ICH guidelines and cGMPs related to the manufacturing of biopharmaceutical product.
Individual must have experience in managing investigations in a GMP manufacturing facility with familiarity in the use of electronic systems (i.e. TrackWise, SAP, LIMS and documentation management systems).
Topics are often of a complex technical nature or pertain to the interpretation of regulatory documents.
Requires ability to work independently and demonstrate ability to exercise sound judgment in critical situations to assure compliance with regulations and procedures while working under tight timelines.
Requires excellent communication skills and the ability to work in a team based environment and interact well with other employees at various levels.
Personnel must demonstrate strong organizational skills, flexibility and capability of handling several high priority items simultaneously on an ongoing basis.
This 6+ month position starts ASAP.
Please E-MAIL your resume (attachment to email) with rate and availability to Patrick: [Click Here to Email Your Resumé]
ALPHA'S REQUIREMENT #17-00602
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