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13 days old

Analyst - Quality Lab

Kelly Services
Manatí, PR 00674
**Analyst - Quality Lab**


Performs testing for raw materials, packaging components, intermediate products, finished products, and ILQs as per current monograph/testing methods, USP, NF, proposed monograph or validation protocols (where applicable).

Processes and reports analytical data utilizing computer systems (e.g., Empower system, SAP, LIMS, etc.) and verifies data generated by other peers.

Evaluates and analyzes data to identify and understand quality performance trends.

Ensures the reliability of the analytical equipment and the integrity of the physical localities through the proper maintenance and housekeeping of the testing areas.

Performs laboratory equipment daily calibrations, verifications, qualification, validation and troubleshooting.

Maintains accurate records of all work performed and document testing results as per Good Documentation Practices and of all laboratory notebooks and worksheets as per QC SOPs.

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

Recommends change to SOPs, protocols, monographs, etc.

Provides support in the investigations of non-conforming results and resolution of investigations.

Assists in new laboratory personnel in training when required.

Follows laboratory SOPs for sample handling and the proper management of data generated.

Participates in Company projects and programs, such as safety and environmental training, GMPs, SOPs and others as required.

Purchases and maintains inventory of required supplies (e.g., standards, reagents, etc.).

Conducts internal audits (e.g., laboratory facilities, reference standard, reagents and product log book audits, etc.).

Ensures that use approved validated methods and specifications, to perform required testing when is involved in testing of finished products, APIs, biological drug substances, raw materials, intermediates / components and ensures all necessary testing is carried out.

Ensures that the QC equipment that will use and that he/she are formally qualified before release testing of products/materials is performed.


Minimum Requirements:


B.S. degree in Science with a major in Chemistry, Biochemistry, Industrial Chemistry

- Experience with Laboratory Investigation and Deviations

- Strong Knowledge and Experience in Raw Materials, Compendial and Non Compendial Methods.

- At least one (1) year of experience in a Pharmaceutical environment

- Working knowledge of computer and appropriate software packages. (e.g., word processing, spreadsheets, Empower, communications like e-mail, LIMS, etc)

- Knowledge on analytical data collection and documentation or other information (e.g. significant figures, rounding off rules, degradation products reporting, etc.)

- Knowledge of laboratory equipment, such as: UV/Vis, pH meter, Balances, pipettes, Karl Fisher, Capillary Electrophoresis, HPLC, TOC, Water analysis.


- Ability to perform basic troubleshooting, PM and/or calibration of laboratory equipment (column care and use, tools, in-line filters, etc.)



* **Non Standard Shift, 3rd Shift Position, availability to work during weekends and holidays.**


**Why Kelly** **** **?**


Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you 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 is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)
Posted: 2021-05-03 Expires: 2021-06-03

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Analyst - Quality Lab

Kelly Services
Manatí, PR 00674

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