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Quality Associate II
Jayuya, Puerto Rico · Biotech/PharmaceuticalJOB PURPOSE:
Coordinate, perform and manage Laboratory Equipment, Software, Method Transfers, Change Control. Assist and supports in Chemical testing.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
• Coordinate Laboratory Equipment, Method transfer and software validation.
• Performs and supports Laboratory Change Control.
• Performs changes to procedures applicable to the process.
• Coordinate/Support/ Perform validations (Laboratory Equipment, Test Method, Test Method transfer, etc.) in a timely manner.
• Manage and use applicable Software Application.
• Coordinate, participate and perform communication, meetings or teleconference with company departments or facilities, as required.
• Able to work under minimum supervision and to handle multiple tasks at the same time.
• Able to prepare and/or provide training, when required.
• Support in internal and external audits.
• Teamwork oriented.
• Other duties may be assigned based on business needs.
QUALIFICATIONS
• EDUCATION and/or EXPERIENCE
Bachelor’s degree in sciences (B.S.) (i.e Biology, Chemistry, Biotechnology, etc.), or Engineering; at least three (3) years of previous experience in Quality and Manufacturing areas; computer knowledge (Word, Power Point, Excel, Trackwise). Laboratory, software and/or test method validation experiences.
LANGUAGE SKILLS
Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals. Ability to write routine reports and correspondence. Ability to speak effectively before groups of employees of organization, supervisors, internal and external audits. Fluently in English and Spanish languages (written and oral). Ability to communicate, read, write and understand English/Spanish languages.
MATHEMATICAL SKILLS
Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals. Ability to compute rate, ratio, and percent and to draw and interpret bar graphs.
REASONING ABILITY
Ability to apply common sense understanding to carry out instructions furnished in written, oral, or diagram form. Ability to deal with problems involving several concrete variables in standardized situations.
CERTIFICATES, LICENSES, REGISTRATIONS, TRAININGS
cGMP’s Training and other trainings, certificates, licenses and registrations that the immediate supervisor refers.
COMPANY REGULATORY COMPLIANCE
Observes and promotes company security, industrial hygiene, cGMP’s, procedures and other security measures already established by the company; should inform any violation.
PHYSICAL DEMANDS
While performing the duties of this job, the employee is regularly required to sit. The employee is occasionally required to stand; walk; use hands to finger, handle, or feel; reach with hands and arms; and talk or hear. The employee must occasionally lift and/or move up to 10 pounds. Specific vision abilities required by this job include close vision.
WORK ENVIRONMENT
While performing the duties of this job, the employee can be exposed to extreme cold. The noise level in the work environment is usually moderate.
SAFETY EQUIPMENT and/or EQUIPMENT
While performing the duties of this job, the employee has to use: computer, telephone, Company Procedures and Policies, office supply, copy machine, fax machine, calculator, and scanner. The incumbent must use the proper equipment in any Baxter area to comply with Company policies, and any internal or external regulation or policy (e.g. safety shoes, safety glasses, ear plugs, safety gloves, etc.).
*Weil Group is proud to be an Equal Employment Opportunity Employer.*
Coordinate, perform and manage Laboratory Equipment, Software, Method Transfers, Change Control. Assist and supports in Chemical testing.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
• Coordinate Laboratory Equipment, Method transfer and software validation.
• Performs and supports Laboratory Change Control.
• Performs changes to procedures applicable to the process.
• Coordinate/Support/ Perform validations (Laboratory Equipment, Test Method, Test Method transfer, etc.) in a timely manner.
• Manage and use applicable Software Application.
• Coordinate, participate and perform communication, meetings or teleconference with company departments or facilities, as required.
• Able to work under minimum supervision and to handle multiple tasks at the same time.
• Able to prepare and/or provide training, when required.
• Support in internal and external audits.
• Teamwork oriented.
• Other duties may be assigned based on business needs.
QUALIFICATIONS
• EDUCATION and/or EXPERIENCE
Bachelor’s degree in sciences (B.S.) (i.e Biology, Chemistry, Biotechnology, etc.), or Engineering; at least three (3) years of previous experience in Quality and Manufacturing areas; computer knowledge (Word, Power Point, Excel, Trackwise). Laboratory, software and/or test method validation experiences.
LANGUAGE SKILLS
Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals. Ability to write routine reports and correspondence. Ability to speak effectively before groups of employees of organization, supervisors, internal and external audits. Fluently in English and Spanish languages (written and oral). Ability to communicate, read, write and understand English/Spanish languages.
MATHEMATICAL SKILLS
Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals. Ability to compute rate, ratio, and percent and to draw and interpret bar graphs.
REASONING ABILITY
Ability to apply common sense understanding to carry out instructions furnished in written, oral, or diagram form. Ability to deal with problems involving several concrete variables in standardized situations.
CERTIFICATES, LICENSES, REGISTRATIONS, TRAININGS
cGMP’s Training and other trainings, certificates, licenses and registrations that the immediate supervisor refers.
COMPANY REGULATORY COMPLIANCE
Observes and promotes company security, industrial hygiene, cGMP’s, procedures and other security measures already established by the company; should inform any violation.
PHYSICAL DEMANDS
While performing the duties of this job, the employee is regularly required to sit. The employee is occasionally required to stand; walk; use hands to finger, handle, or feel; reach with hands and arms; and talk or hear. The employee must occasionally lift and/or move up to 10 pounds. Specific vision abilities required by this job include close vision.
WORK ENVIRONMENT
While performing the duties of this job, the employee can be exposed to extreme cold. The noise level in the work environment is usually moderate.
SAFETY EQUIPMENT and/or EQUIPMENT
While performing the duties of this job, the employee has to use: computer, telephone, Company Procedures and Policies, office supply, copy machine, fax machine, calculator, and scanner. The incumbent must use the proper equipment in any Baxter area to comply with Company policies, and any internal or external regulation or policy (e.g. safety shoes, safety glasses, ear plugs, safety gloves, etc.).
*Weil Group is proud to be an Equal Employment Opportunity Employer.*