Viatris Pharmaceuticals LLC
At VIATRIS, we see healthcare not as it is but as it should be. We act courageously and are uniquely positioned to be a source of stability in a world of evolving healthcare needs.
Viatris empowers people worldwide to live healthier at every stage of life.
We do so via:
Access
– Providing high quality trusted medicines regardless of geography or circumstance;
Leadership
– Advancing sustainable operations and innovative solutions to improve patient health; and
Partnership
– Leveraging our collective expertise to connect people to products and services.
Every day, we rise to the challenge to make a difference and here's how the QC Inspector role will make an impact:
Perform sampling for testing of incoming materials (raw materials and packaging components) for the analytical (chemistry) and microbiological laboratory. Perform/verify packaging components dimensional tests against approved component specifications and proof of text. Receive, dispatch and keep control of the retained samples room. Perform sampling of the water systems applying aseptic techniques. Perform statistical evaluations requested by Manufacturing and Packaging areas. Localize, identify, and segregate questionable materials along with Warehouse personnel.
Review Temperature and humidity charts, as required.
Maintains all areas in which he or she works in a clean and orderly manner.
Complies with all SOP, GMP and good documentation practices.
Labels rejected materials according to SOP instructions.
Registers (subtracts) quantities related to sampling in the Inventory System.
Change lots of status in the Inventory System as required (i.e. Rejects).
Coordinates with calibration department the calibration of the required equipment.
Protects and gives good use to company's tools and equipments.
Maintains binder with SDS .
Delivers any pertinent documents to QA, PMC room, Central File or others area (as required).
Ensures compliance with data integrity principles and documentation procedures.
Ensure Controlled Substance is managed as per Regulation requirements and following procedure instructions.
Verifies that all received materials complies with receiving requirements as per SOP (COA and/or COC) and are from approved suppliers.
Inspects API, raw material, Packaging Components and Bulk Products to ensure containers comply with requirements in regard to essential information and satisfactory conditions of containers vs receiving documentation.
Samples materials and products according to statistical and laboratory requirements established following applicable procedures.
Identifies all samples and sampled containers accurately and following procedures.
Deliver required samples to retain room, analytical or micro labs.
Moves or coordinates movement of materials to the sampling room, looking in the inventory system (SAP) its physical location.
Evaluates materials and products sample during sampling for description and foreign matters.
Performs ID Test to raw materials and API's, if required.
Performs visual inspection, and Identification if applicable, of the product transferred lot to be packaged in Vega Baja.
Documents results in Inspections Reports complying with good documentation practices according to procedures.
Enters accurate information in the Inspection logbooks.
Destroys inspected samples following applicable procedures, if applicable.
Performs and documents calibration verification to area balances.
Monitors, changes and documents temperatures and humidity recorder charts. Notify the QC Team Leader if any discrepancy is detected.
Localizes, reconciles, identifies and moves questionable materials to the appropriate area. Notify the QC Team Leader if any discrepancy is detected.
Evaluates packaging components against approved specification and proof of text.
Documents results in Inspections Reports complying with good documentation practices.
Enters accurate data in the Inspection electronic logbooks updated according "FIFO" approach.
Performs and documents calibration verification to area balances.
Performs statistical sampling to granulations, bulk products and finished goods for attributes evaluations.
Prepares results reports of statistical samplings.
Picks up finished goods retain samples from packaging areas.
Assures correctness of sample quantity according to SOP requirements.
Segregates samples according to required retention storage time.
Verifies appearance of Bulk and Finished Products samples and reports it in the corresponding document to be sent to QA and in the logbook.
Verifies raw materials and packaging components retain samples.
Perform the product annual check according to the procedure.
KNOWLEDGE
Knowledge of laboratory equipment, sampling, and techniques.
Laboratory General Rules
Sampling and Packaging Testing Safety Rules
Company's EHS Programs following established policies and procedures, and Corporate EHS Guidelines, and will be trained in all applicable EHS procedures and regulations that apply to specific job functions.
Ensure that any waste (hazardous, non-hazardous or special waste) generated as part of his/her responsibilities are handled in compliance with applicable environmental regulations and in accordance to established SOP's for handling hazardous and biomedical wastes.
SKILLS AND ABILITIES
Ability to read and write in English and Spanish. Bilingual (English/Spanish).
Available to provide on call support during weekends and after working hours.
Team collaboration.
Willing to work irregular hours, weekends and holidays when necessary.
Attention to details.
Ability to work under pressure.
Ability to use Microsoft office.
EDUCATION/EXPERIENCE
Associate degree or High School graduate with one (1) year of experience in the Pharmaceutical Industry in Quality Control Department.
At Viatris, we offer competitive salaries, benefits and an inclusive environment where you can use your experiences, perspectives and skills to help make an impact on the lives of others.
Viatris is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, national origin, religion, age, color, sex, sexual orientation, gender identity, gender expression, disability, or protected veteran status, or any other characteristic protected by local, state, or federal laws, rules, or regulations.
