Company: Thermo Fisher Scientific Location: Indianapolis, IN Employment Type: Full Time Date Posted: 01/23/2021 Expire Date: 03/31/2021 Job Categories:
Biotechnology and Pharmaceutical, Government and Policy, Manufacturing and Production, Executive Management, Quality Control, Medical, Environmental
Quality Assurance Specialist, 2nd Shift
Thermo Fisher Scientific is the world’s leader in “serving science,” we enable our customers to make the world healthier, cleaner and safer. We are a $22 billion company with nearly 70,000 employees in 50 countries around the world. We serve primarily the pharmaceutical, biotechnology, and bio-research industries – which makes our clients organizations like hospitals and clinical diagnostic labs, universities, research institutions and government agencies, as well as other environmental and industrial process control settings.
Essential Duties and Responsibilities:
Apply Good Manufacturing Principles in all areas of responsibility.
Demonstrate and drive the Thermo Fisher values – Integrity, Intensity, Involvement and Innovation (The Four I’s).
Ensure appropriate execution of the Quality Systems to sustain cGMP compliance.
Ensure adequate document control for manufacturing and packaging instructions and cGMP Standard Operating Procedures.
Assist with deviation identification & Perform Packaging In-Process checks
Perform Manufacturing In-Process checks
Provide assistance and guidance on quality issues for Operations. Escalate necessary issues to Quality Assurance Representative and/or Manager.
Assist with periodic self-inspections to assure cGMP compliance.
Conduct all activities in a safe & efficient manner.
Additional duties and responsibilities regarding Label Document Compliance:
Thoroughly examine Label Specifications, Master Label Proofs, Randomizations, and Links Reports to assure cGMP’s are met and performed according to customer specifications and regulatory requirements.
Correct documentation by noting and forwarding deficiencies to be corrected; tracking correction of deficiencies.
Verify corrections prior to approval.
Review/approve printed labels, printed packaging components and Fisher-supplied packaging components.
Thorough understanding of all documentation and processes associated with inspections in Label Document Compliance and comprehensive knowledge and skill of document inspections by visual inspection, Docu-Proof, and TVT.
Other duties may be assigned to meet business needs.
Split shift hours are Monday-Thursday, 10 hour shifts, 2:45pm-1:30am
Basic Minimum Qualifications:
To perform this job successfully, the individual must be able to perform each essential duty satisfactorily. The requirements below are representative of the knowledge, skill or ability required.
High school degree with relevant experience necessary to fulfill this duty.
Experience in packaging, labeling and distribution is a plus.
Experience and knowledge of Microsoft Word and Excel preferred.
cGMP Manufacturing, Packaging or QA/QC experience preferred.