Responsibilities include review of line documentation related to Steriles Manufacturing and Filling. Responsible for conducting technical quality and compliance reviews in accordance with current Good Manufacturing Practices (cGMPs), FDA regulations and Standard Operating Procedures (SOPs). Will follow up on customer inquiries as they relate to same documentation and compliance issue. Responsible for participating in audits. This position will review and must have an understanding of the implications of the work and knowledge of the context in which the work is being performed. Position is final review and ultimate release for product distribution.
Responsible for printing and reviewing of documentation related to manufacturing and filling after completion of reconciliation.
Responsible for critical review of all above documentation for errors, omissions, over-writes and compliance to cGMPs, customer specifications, and internal SOP’s.
Responsible for follow-up on all customer inquiries specific to documentation related to the manufacturing, filling, testing and release of the work in-process or finished product.
Responsible for final release of work in-process or finished product.
Responsible for participating in internal, customer, and regulatory audits.
Responsible for training others within the department.
Knowledgeable of cGMPs and application of good documentation practices within pharmaceutical industry.
Attentive to detail, able to recognize critical attributes, steps and functions relating to manufacturing and filling processes.
Ability to review approved manufacturing and filling investigations/deviations to determine final QA disposition.
Experience in quality reviews of manufacturing and filling batch records.
Support manufacturing and filling services through the review and approval of master batch records and completed manufacturing and filling records for review, approval, and release of product.
Document control through management, issuance, authoring, and approval of documents (SOPs, Monographs, Investigations).
Management of equipment in the QA databases.
Interact with clients to build relationships to anticipate, meet, and exceed client expectations.
Position Reports to Operations Management.
Development, approval, revision and issuance of manufacturing and filling records.
Processing release paperwork, large document scanning and emailing.
High School Diploma or equivalent required.
Seven years of administrative experience preferred.
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Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.