Administrative Services Coordinator II

When you're part of the team at Thermo Fisher Scientific, you'll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and you'll be supported in achieving your career goals.How will you make an impact?Responsibilities include review of line documentation related to 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.What will you do?

Responsible for printing and reviewing of documentation related to manufacturing and filling after completion of reconciliation.

Responsible for the print and release of pre-executed product work orders to the production floor.

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.

How will you get here?Education

High School Diploma or equivalent required.

Equivalent combinations of education, training, and relevant work experience may be considered.

Experience-

Two to four years of administrative experience preferred.

Knowledge, Skills, Abilities

Strong proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint).

Effective written and verbal communication skills.

Ability to work on multiple projects simultaneously.

Must be able to work in a fast-paced environment with demonstrated ability to prioritize and be self-directed.

Possess analytical ability in order to gather and summarize data for reports and find solutions to various administrative problems.

Ability to coordinate multiple activities while maintaining a high level of accuracy.

Attention to detail. Ability to collaborate effectively with others to achieve goals and expectations.

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $25 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them. Our global team of more than 75,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon. For more information, please visit www.thermofisher.com .Thermo Fisher Scientific is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, creed, religion, color, national or ethnic origin, citizenship, sex, sexual orientation, gender identity and expression, genetic information, veteran status, age or disability status.