9 days old

Incoming Laboratory Analyst

Kelly Services
Manatí, PR 00674
**Incoming Laboratory Analyst**

**Hours:** Available for all shifts first, second and third.

**Contract assignment:** until March 2023

Performs sampling and inspection for raw materials (RM) / excipients / Active Pharmaceutical Ingredients (API) / Drug Substances (DS). Performs sampling of retain samples for raw materials and drug substances to fulfill retain sample program requirements. Performs sampling, inspection and testing for packaging components, including visual, dimensional and functional tests.

Performs inspection and sampling (when applicable) for sterile materials, sterile garments and material requirement sheet. Supports Material/Laboratory Qualifications as per current Testing Standards and/or monograph, USP, NF or validation protocols (where applicable). Performs investigations of non-conforming results and resolution of investigations. Performs and reviews required testing of materials and products in accordance with company specifications and/or applicable compendia.

Performs the disposition of packaging components according to results obtained.

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.

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.

Recommends and make changes to documents such as: SOPs, protocols, methods, work instructions, operational procedures, etc.

Monitors laminar flow hood sample area parameters (e.g., humidity, temperature, differential pressure, etc.) and communicates excursions to supervisor.

Participates in process validation, laboratory equipment qualification, and analytical method transfers.

Coordinates with Microbiology and /or Analytical Laboratory the required testing corresponding to Active Product Ingredients, excipients and packaging components.

Coordinates sampling and sample delivery to outside laboratories for testing that cannot be performed in-house.

Provides training to new members on applicable OJT, tasks and SOPs.

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.

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.

Assures to be formally qualified before performing any release testing of materials.

Verifies consistency with other site procedures and/or specifications and verifies compliance with company Policies and Guidelines.

Performs adjustments in SAP system to maintain inventory and change material status in SAP according to applicable procedures.

Performs cleaning on API and Raw Materials Rooms.

Generates Work order in Maximo system for equipment repairs, facility repairs, etc.

Tracks materials status through the QA 33 report from SAP to maintain Incoming Attainment metrics within business goals.

Participate in daily Tier 1 meeting.

Execute approve supplier list verification against SAP system.


Bachelors degree in Natural Sciences

One (1) year of experience within Quality Control Laboratory in a Pharmaceutical Industry.

**You should know:** Your safety matters! Vaccination against COVID-19 may be a requirement for this job in compliance with current client and governmental policies. A Kelly recruiter will confirm and share more details with you during the interview process.

**Why Kelly** **** **Science & Clinical?**

Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the worlds most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goalsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.

**About Kelly** ****

At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.

Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kellys Human Resource Knowledge Center.
Kelly complies with the requirements of Californias state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.
Posted: 2022-09-23 Expires: 2022-10-24

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Incoming Laboratory Analyst

Kelly Services
Manatí, PR 00674

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