1. Performs testing, sampling and inspection for raw materials/excipients, packaging components, intermediate products, retain samples , finished products and Inter Laboratory Qualifications as per current Testing Standards and/or monograph, USP, NF or validation protocols (where applicable).
2. Performs investigations of non-conforming results and resolution of investigations.
3. Performs and reviews required testing of materials and products in accordance with Client specifications and/or applicable compendia.
4. Performs the disposition of packaging components according to results obtained.
5. Processes and reports analytical data utilizing computer systems (e.g., Empower system, SAP, LIMS, etc.) and verifies data generated by other peers.
6. Operates laboratory equipment, such as:UV-Visible, FTIR, HPLC, GC, and others.
7. Recommends and make changes to documents such as:SOPs, protocols, methods, operational procedures, etc.
8. Monitors laminar flow hood sample area parameters (e.g., humidity, temperature, differential pressure, etc.) and communicates excursions to supervisor.
9. Participates in process validation, laboratory equipment qualification, and analytical method transfers.
10. Coordinates with Microbiology and /or Analytical Laboratory the required testing corresponding to Active Product Ingredients, excipients and packaging components.
11. Coordinates with outside laboratories tests that can not be performed in-house.
12. Provides training to new members on approved monographs and procedures following applicable training SOP and training support for Manufacturing and QA personnel (e.g., expiration dating SOP, etc.).
13. Approves validated methods and specifications, robust systems and adequate facilities to perform required testing when is involved in testing of finished products, API’s, biological drug substances, raw materials, intermediates / components and ensures all necessary testing is carried out.
14. Assures to be qualified in the use of QC equipment and that the QC equipment is formally qualified before release testing of products/materials.
15. Assures to be formally qualified before performing any release testing of products/materials.
16. Verifies consistency with other site procedures and/or specifications and verifies compliance with Client Policies and Guidelines.
17. Performs adjustments in SAP system to maintain inventory.
18. Performs cleaning and environmental monitoring activities on API and Raw Materials Rooms.
19. Generates Work order in Maximo system for equipment repairs, facility repairs, etc.
20. Tracks materials status through the QA 33 report from SAP to maintain QC Attainment metrics within business goals.
KNOWLEDGE / SKILL:
Bachelor’s degree in Natural Sciences
One (1) year of experience within Quality Control Laboratory in a Pharmaceutical Industry.
Working knowledge of computer and appropriate software packages. (e.g., Empower, LIMS and Microsoft Office (Word , Excel, Power Point),
Knowledge to collect and document data and or other information (e.g. significant figures, rounding off rules, degradation products reporting, etc.).
Ability to perform basic troubleshooting, PM and/or calibration of laboratory equipments (column care and use, tools, in-line filters, etc.).
In-depth knowledge in the use and interpretation of USP/NF and a working knowledge of QC SOP’s, cGMP’s, federal and other countries regulatory requirements.
Ability to conduct a variety of analytical techniques.
Knowledge of cGMPs, EU and other regulatory requirements.
Basic mathematical, statistical, and analytical skills.
Thorough understanding of cGMP and laboratory documentation procedures (e.g., good documentation practices, SOP’s, etc.).
Knowledge of sampling plans (e.g., ANSI/ASQ Z1.4 /Z1.9).
Knowledge of the SAP System.
Proficiency in oral and written communication skills both English and Spanish.
Good organizing and planning skills.
Capacity to use Safety Respirator and capacity to perform the Safety gowning.
Willing to work irregular hours, rotation shifts, weekends, and holidays, when necessary