Lab Technician

POSITION PURPOSE

A brief summary of the purpose this position must fulfill.

A Highly mature Specialist who will lead or work on his/her own, in developing and improving new

technology. In addition, to the necessary technical and creative skills, this person will provide guidance

in the areas of expertise to other departments as require. These resources must conduct (create,

execute and report) equipment validation and research projects.

Perform job functions in accordance with all applicable Standard Operating Procedures (SOP), federal

and state laws, Occupational Safety and Health Administration (OSHA) guidelines, health authority

regulations, and departmental processes.

ESSENTIAL DUTIES AND RESPONSIBILITIES

To perform this position successfully, an individual must satisfactorily perform each essential duty.

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential

duties.

1. Identifies and implements new technology, systems, and equipment for QC Laboratories.

2. Provides technical support and training on new systems, and techniques.

3. Develops and/or modifies Standard Operational Procedures.

4. Participates in the preparation, analysis, and control of assigned portion(s) of annual budget of

his or her area.

5. Advanced mathematical skills

6. Identifies and implements cost improvements and avoidance (CIP) measures,

7. Identifies and implements process improvement opportunities.

8. Identifies, configures, validates, and implements gLIMS objects and /or structures (Standards

and Reagents, Test Methods, Specifications, Instruments)

9. Responsible for the coordination of activities required from QC (none testing activities) in the

transfer of new products and or existing products.

a. Review/approval of regulatory documentation

i. Protocols, reports and specifications.

10. Responsible for the coordination of activities required on the Laboratories.

a. Equipment’s Calibration, PM and non - routine services

b. Equipment’s Validation

c. Method Validation and / or methods improvements.

11. Acts as a liaison between technical development and QC during the transfer of new products.

12. Available to work and provide support during weekends and after working hours.

QUALIFICATIONS

The qualifications listed below are representative of the minimum knowledge, skill, and/or ability required.

KNOWLEDGE

Must possess knowledge of:

• GMP�s, validation principles and audit techniques.
  
• NDA, CMC and DEA/FDA regulations.
  
• Compendial methodologies (USP, EP, JP, CH ).
  
• Quality Systems.
  
• Be able to proactively assess and influence RA from different countries related to site
  
• Minimum of 1 year of experience.
  

registrations including changes.

• Proficient in computer software's such as Microsoft Office.
  
• Fully bilingual both, verbal and written (English and Spanish)
  

SKILLS AND ABILITIES

Must possess:

• Ability to handle several priorities simultaneously.
  
• Excellent negotiation skills, leadership, and analytical thinking
  

SUPERVISION

Position functions semi-autonomously.

EDUCATION/EXPERIENCE

• Bachelor�s degree in pharmacy, chemistry, natural science, engineering, or other closely
  

related area.

• At least five (5) years of experience in the pharmaceutical industry with similar
  

responsibilities.

• However, a combination of experience and education will be considered.
  

LICENSES/CERTIFICATIONS

Chemist License is required or experience in Validation / Qualifucation

LANGUAGE SKILLS

Advanced

Ability to read and interpret comprehensive and intricate research documents. Ability to write

scientific reports and technical correspondence. Ability to work with executives and communicate

abstract concepts. Ability to present to a high level of the organization and groups outside of the

organization.

MATHEMATICAL SKILLS

Advanced

Ability to solve equations, apply technical mathematical concepts, and perform complex

computations.

If specific mathematical skills, not mentioned in the descriptions above, are required for the

position, please list them in addition to the appropriate standard description.

Advanced

Ability to solve problems with complex variables through non-standardized solutions that require

independent judgment and analysis. Ability to draw inferences and use deductive reasoning with

no prescribed procedures to solve complex problems.

PHYSICAL DEMANDS

The physical demands described here are representative of those that must be met by an employee to

successfully perform the essential duties of this position. Reasonable accommodations may be made to

enable individuals with disabilities to perform essential duties.

Production Related

May be required to stand; walk; stoop; bend; kneel; and climb steps. May require use of hands and

use of arms to lift and scoop. May be required to lift or maneuver boxes or containers using lifting

equipment, as well as physically pushing, rolling or lifting. Medium lifting requirements.

May be required to wear personal protective equipment including but not limited to: respiratory

protection, safety glasses, hearing protection, safety shoes and protective clothing.

WORK ENVIRONMENT

The work environment characteristics described here are representative of those an employee

encounters while performing the essential duties of this position. Reasonable accommodations may

be made to enable individuals with disabilities to perform essential duties. Normal office situation.

DISCLAIMER:

This description is based on management’s assessment of the requirements and functions of the job

as of the date this description was prepared. It is a general guideline for managers and colleagues, but

it does not purport to be an exhaustive list of all the elements of the job. Management reserves the

right to modify the description at any time, or to vary the duties and responsibilities of the job on a

temporary or indefinite basis to meet production, scheduling or staffing needs.

Job Types: Full-time, Contract, Temporary

Pay: From $15.00 per hour

Expected hours: 40 per week

Schedule:

• 10 hour shift
  
• 12 hour shift
  
• 8 hour shift
  
• Day shift
  
• Evening shift
  
• Monday to Friday
  
• Overtime
  
• Weekends as needed
  

Ability to Commute:

• Vega Baja, PR 00693 (Required)
  

Ability to Relocate:

• Vega Baja, PR 00693: Relocate before starting work (Required)
  

Work Location: In person