Quality Assurance Specialist
Company: Nitto Denko Avecia
Location: Cambridge
Posted on: January 12, 2021
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Job Description:
Equal Opportunity Employer Purpose of the Position:The position
is responsible for documenting and auditing cGMP practices for the
site. The position develops and revises QA procedures to strengthen
cGMP compliance.Key Job Responsibilities:--- Responsible for
reviewing quality records/batch records--- Act as lead auditor
during vendor/internal quality audits to ensure that cGMP
compliance is at the required standard for API manufacture, in
accordance with ICH Q7 Guidance and FDA 21 CFR requirements. ---
Provide cGMP training to site staff as needed and assure that there
is full understanding of the Milford site Quality procedures.---
Responsible for writing/revising Quality Assurance procedures to
strengthen compliance with cGMPs. --- Review and approve deviation
and gather/issue quality metric reports to executive management.---
Provide strong link/communication between the QA
function/activities with all other departments at the Milford
site.--- Act as QA representative on project teams. Reviewer of
project documents (PIs, Technical Reports, Validation documents)---
Review Certificates of Analysis (COA) and Certificates of
Conformance (CoC) for accuracy and release product. --- Provide
assistance during cGMP compliance inspections of the Milford
facility. This includes the retrieving of quality
documents/records/trend data and any other documentation requested
during these inspections.Job Knowledge Required:The job requires a
BS/BA in science or equivalent work experience with 3-5 years
experience in either Production or Quality Assurance.The QA
Specialist must be able to provide expert advice and sound
decision-making on all aspects of cGMP. He/she must have a strong
knowledge of the cGMP regulation and technical knowledge of the
subject and the potential issues involved. This is achieved through
a combination of experience in Quality Systems coupled with
education and training in Quality Systems, cGMP, Quality audits,
documentation, change control, corrective preventative action,
validation, calibration, review of quality records, quality
metrics, failure investigations and manufacturing and laboratory
controls as per cGMPs. As the regulatory and cGMP requirements
frequently change, the jobholder must also maintain current
knowledge. The QA Specialist III must have strong attention to
detail and self-checking skills.
Keywords: Nitto Denko Avecia, Cambridge , Quality Assurance Specialist, Other , Cambridge, Massachusetts
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