Location: Jayuya,PR, USA
Provides technical support to the chemistry laboratory personnel. Performs and/ or review/ approve chemistry laboratory tests to avoid delay in the release of the product, assuring a quality and safety work.
**ESSENTIAL DUTIES AND RESPONSIBILITIES:**
Responsible to achieving accurate laboratory testing results lies with the analyst who is performing the test.
Should be aware of potential problems that could occur during the testing process and should watch for problems that could create inaccurate results.
Approves and reviews documents, assures that the Department complies with internal and external regulations and standards.
Performs any work to avoid the delay in the release of the product.
Analyzes purchase raw materials against established procedures assuring compliance with all regulations and specifications.
Review and/or approval of laboratory documentation.
Must follow the current Good Manufacturing Practices (cGMPs), current Good Documentation Practices (cGDPs) and current Good Laboratory Practices (cGLP).
Audits chemical test procedures, retests, additional testings and SOP's in the laboratory.
Requests and order all materials required in the laboratory on timely basis to assure an efficient performance (make request of accessories, equipment, reagents, etc.; including the issuance of purchase orders).
Initiates and implement changes or new chemical procedures including data gathering.
Capable to develops, modifies and analyzes protocols and procedures as required.
Prepares general material and solutions needed for laboratory tests, as required.
Sanitize the work areas before and after operations.
Keeps the work area in the cleanest and order conditions.
Should be able to work within minimum supervision.
Should be able to work with many projects and handle multiple tasks at the same time.
Willing to work extra hours, at any shift when its required, on Holidays and during special periods (eg. shutdowns, internal and external audits, special projects).
Performs statistical data evaluation (such as: Water analysis, etc.), as required.
Run and troubleshoots the laboratory computer systems, as requires.
Performs laboratory tests; and prepares and evaluates control charts, using laboratory data.
Team worked oriented and participate in laboratory audits.
Should be able to work on special projects as assigned. Complies with the established milestones for projects.
Supports training activities in SOP's and changes, when required.
Prepares monthly, quarterly and annual reports for the chemical laboratory indicators as required.
Performs internal audits to areas of responsibility and document findings and suggestions to improve processes.
Performs laboratory Investigations, when requested.
Additional task can be assigned as business needs.
Available to work in extended shift and weekend as needed.
**QUALIFICATIONS**
** EDUCATION and/or EXPERIENCE**
B.S. in Chemist (Master Degree desirable but not required) Puerto Rico Chemist License (preferred). At least two years of experience in a Pharmaceutical Industry (preferable). Strong knowledge in HPLC, Atomic Absorption, FT-IR, Karl Fisher, UV/VIS, TOC Analyzer, Polarimeter. Strongly oriented to GMPs, GLPs, OSHA, US Pharmacopeia, EP, Good troubleshooting resolution techniques. Strong knowledge in LIMS etc.Provides technical support to the chemistry laboratory personnel. Performs and/ or review/ approve chemistry laboratory tests to avoid delay in the release of the product, assuring a quality and safety work.
**ESSENTIAL DUTIES AND RESPONSIBILITIES:**
Responsible to achieving accurate laboratory testing results lies with the analyst who is performing the test.
Should be aware of potential problems that could occur during the testing process and should watch for problems that could create inaccurate results.
Approves and reviews documents, assures that the Department complies with internal and external regulations and standards.
Performs any work to avoid the delay in the release of the product.
Analyzes purchase raw materials against established procedures assuring compliance with all regulations and specifications.
Review and/or approval of laboratory documentation.
Must follow the current Good Manufacturing Practices (cGMPs), current Good Documentation Practices (cGDPs) and current Good Laboratory Practices (cGLP).
Audits chemical test procedures, retests, additional testings and SOP's in the laboratory.
Requests and order all materials required in the laboratory on timely basis to assure an efficient performance (make request of accessories, equipment, reagents, etc.; including the issuance of purchase orders).
Initiates and implement changes or new chemical procedures including data gathering.
Capable to develops, modifies and analyzes protocols and procedures as required.
Prepares general material and solutions needed for laboratory tests, as required.
Sanitize the work areas before and after operations.
Keeps the work area in the cleanest and order conditions.
Should be able to work within minimum supervision.
Should be able to work with many projects and handle multiple tasks at the same time.
Willing to work extra hours, at any shift when its required, on Holidays and during special periods (eg. shutdowns, internal and external audits, special projects).
Performs statistical data evaluation (such as: Water analysis, etc.), as required.
Run and troubleshoots the laboratory computer systems, as requires.
Performs laboratory tests; and prepares and evaluates control charts, using laboratory data.
Team worked oriented and participate in laboratory audits.
Should be able to work on special projects as assigned. Complies with the established milestones for projects.
Supports training activities in SOP's and changes, when required.
Prepares monthly, quarterly and annual reports for the chemical laboratory indicators as required.
Performs internal audits to areas of responsibility and document findings and suggestions to improve processes.
Performs laboratory Investigations, when requested.
Additional task can be assigned as business needs.
Available to work in extended shift and weekend as needed.
**QUALIFICATIONS**
** EDUCATION and/or EXPERIENCE**
B.S. in Chemist (Master Degree desirable but not required) Puerto Rico Chemist License (preferred). At least two years of experience in a Pharmaceutical Industry (preferable). Strong knowledge in HPLC, Atomic Absorption, FT-IR, Karl Fisher, UV/VIS, TOC Analyzer, Polarimeter. Strongly oriented to GMPs, GLPs, OSHA, US Pharmacopeia, EP, Good troubleshooting resolution techniques. Strong knowledge in LIMS etc.
**Pay Details:** $24.00 per hour
Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits and a 401K plan. Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs. In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable.
Equal Opportunity Employer/Veterans/Disabled
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The Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements, including, as applicable:
+ The California Fair Chance Act
+ Los Angeles City Fair Chance Ordinance
+ Los Angeles County Fair Chance Ordinance for Employers
+ San Francisco Fair Chance Ordinance