Quality - Incoming Laboratory Analyst

at  Weil Group Inc

Manatí Municipio, Puerto Rico, USA - 00000

Start DateExpiry DateSalaryPosted OnExperienceSkillsTelecommuteSponsor Visa
Immediate12 Nov, 2022Not Specified12 Aug, 2022N/ASpanish,Laboratory Equipment,Analytical Skills,Natural Sciences,Communication Skills,Microsoft Office,Analytical Techniques,Excel,Regulatory Requirements,Pharmaceutical Industry,Sap SystemNoNo
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Description:

MAJOR DUTIES AND RESPONSIBILITIES: State the most important activities and accountabilities of this position.
1. Performs sampling and inspection for raw materials (RM) / excipients / Active Pharmaceutical Ingredients (API) / Drug Substances (DS).
2. Performs sampling of retain samples for raw materials and drug substances to fulfill retain sample program requirements.
3. Performs sampling, inspection and testing for packaging components, including visual, dimensional and functional tests.
4. Performs inspection and sampling (when applicable) for sterile materials, sterile garments and material requirement sheet.
5. Supports Material/Laboratory Qualifications as per current Testing Standards and/or monograph, USP, NF or validation protocols (where applicable).
6. Performs investigations of non-conforming results and resolution of investigations.
7. Performs and reviews required testing of materials and products in accordance with Client specifications and/or applicable compendia.
8. Performs the disposition of packaging components according to results obtained.
9. Processes and reports analytical data utilizing computer systems (e.g. TrackWise (TW), Infinity, Maximo, Ariba, SAP, LIMS, Scan TVS Proof Reader, Vision System, Bluehill Software, etc.) and verifies data generated by other peers. Issue change request to create new items in LIMS system.
10. Operates laboratory equipment, such as: Ruler, Caliper, Instron, Optical Comparator, Vision System, Scan TVS, Barcode Reader (Cognex), Micrometers, gauges, Go-No Go gauges and others.
11. Recommends and make changes to documents such as: SOPs, protocols, methods, work instructions, operational procedures, etc.
12. Monitors laminar flow hood sample area parameters (e.g., humidity, temperature, differential pressure, etc.) and communicates excursions to supervisor.
13. Participates in process validation, laboratory equipment qualification, and analytical method transfers.
14. Coordinates with Microbiology and /or Analytical Laboratory the required testing corresponding to Active Product Ingredients, excipients and packaging components.
15. Coordinates sampling and sample delivery to outside laboratories for testing that cannot be performed in-house.
16. Provides training to new members on applicable OJT, tasks and SOPs.
17. Ensures that approved validated methods and specifications, robust system and adequate facilities are used to perform requires testing for RM, API, Excipients, Drug Substances, Packaging Components among others.
18. Assures to be qualified in the use of Incoming Laboratory equipment and that the Incoming equipment is formally qualified before releasing materials such as RM, API, Drug Substances, Excipients, Packaging Components among others.
19. Assures to be formally qualified before performing any release testing of materials.
20. Verifies consistency with other site procedures and/or specifications and verifies compliance with Client Policies and Guidelines.
21. Performs adjustments in SAP system to maintain inventory and change material status in SAP according to applicable procedures.
22. Performs cleaning on API and Raw Materials Rooms.
23. Generates Work order in Maximo system for equipment repairs, facility repairs, etc.
24. Tracks materials status through the QA 33 report from SAP to maintain Incoming Attainment metrics within business goals.
25. Participate in daily Tier 1 meeting.
26. Execute approve supplier list verification against SAP system.

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., Trackwise, SAP, 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 of Incoming Laboratory equipment including but not limited to system check, setting and daily verification.
  • In-depth knowledge in the use and interpretation of Testing Standards and a working knowledge of QC SOP’s, cGMP’s, federal and other countries regulatory requirements.
  • Ability to conduct a variety of analytical techniques including but not limited to visual, dimensional and functional tests for packaging components.
  • 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.
  • Disposed to work irregular hours, rotation shifts, weekends, and holidays, when necessary
  • Inspection tasks require 20/20 visual eye accuracy and color detection with or without correction

Responsibilities:

Please refer the Job description for details


REQUIREMENT SUMMARY

Min:N/AMax:5.0 year(s)

Pharmaceuticals

Pharma / Biotech / Healthcare / Medical / R&D

Clinical Pharmacy

Graduate

Natural sciences

Proficient

1

Manatí Municipio, PR, USA