Associate Quality Analyst - Artech LLC
Barceloneta, PR 00617
About the Job
Position Title Associate Quality Analyst
Number of Positions Needed 3
Length of Contract: 6 months
What are the top 3-5 skills, experience or education required for this position? Technical Skills:
Good verbal and written communication skills in both Spanish and English
Good problem solving and analytical skills
Good interpersonal relations / communications skills
Good negotiation skills
What is a nice to have (but not required) skill, experience, education, or certification? The combination of experience in one or more of the additional requirements listed below is a plus:
• Aseptic processing experience
• Quality Assurance experience
• Visual inspection of parenteral products experience – Principal activity.
• Participation and/or experience in Aseptic Process Simulation (Media Fills)
• Prior experience/certification in sterile gowning
• Prior experience in surveillance of aseptic filling process is a plus
General Position Summary/Purpose:
This is a new position/schedule. workers should be available to work on rotating shift every week due to 24/7 new business operation. final schedule still under revision.
During routine operations, the Associate SVP Quality Analyst is responsible for carrying out Manufacturing Quality Assurance functions within the ABL plant including performing Line Inspections, Quality Visual Inspections and Tub Hold management process. The incumbent supports the visual inspection certification process, resolution of deviations, participating in investigations, and assurance of compliance with cGMP and Client policies for the manufacturing plant.
Key Accountabilities/Core Job Responsibilities:
• Responsible for performing the SVP Line Inspections, Quality Visual Inspection (i.e. AQL) and provide support for the Tub Hold Management process.
• Supports Visual Inspection Certification Process. May act as Subject Matter Expert (SME) for the Visual Inspection Process.
• Support quality goals ensuring that all practices and procedures comply with GPO and Corporate policies and applicable regulations for the Quality areas under his/her responsibility.
• Support SVP Media Fill Program and QA Oversight execution activities.
• Place product on QA hold when required. Maintains an effective liaison and cooperative relationship with other Quality areas and Plant departments.
• Revise standard operating procedures; ensures procedures comply with Client policies and cGMP guidelines.
• Demonstrates accountability and responsibility of EHS performance and compliance
Additional requirements that we are looking for are:
• Aseptic processing experience
• Quality Assurance experience
• Visual inspection of parenteral products experience
• Participation and/or experience in Aseptic Process Simulation (Media Fills)
• Prior experience/certification in sterile gowning
• Prior experience in surveillance of aseptic filling process is a plus
Qualifications
Education, Qualifications and Experience Requirements (degree, certifications, etc.):
Education: Bachelor degree in biotechnology/biopharma, biology, chemistry or engineering. Pharmaceutical experiences can be considered. Master degree is not needed. at least 1 year biotechnology/biopharma with aseptic processing experience is desired.
Daily Work Schedule Expectations Rotating shift and weekend – All candidates must be available to work any shift including weekend, based in business needs.
Interviews:
How many rounds of interviews? 1 round
Who will be involved in the interview process? Ingrid Boneta / Panel Interviews
Type of interview (video, phone or onsite)?
On site preferred interviews or video interviews if needed (evaluation will be case by case)
Number of Positions Needed 3
Length of Contract: 6 months
What are the top 3-5 skills, experience or education required for this position? Technical Skills:
Good verbal and written communication skills in both Spanish and English
Good problem solving and analytical skills
Good interpersonal relations / communications skills
Good negotiation skills
What is a nice to have (but not required) skill, experience, education, or certification? The combination of experience in one or more of the additional requirements listed below is a plus:
• Aseptic processing experience
• Quality Assurance experience
• Visual inspection of parenteral products experience – Principal activity.
• Participation and/or experience in Aseptic Process Simulation (Media Fills)
• Prior experience/certification in sterile gowning
• Prior experience in surveillance of aseptic filling process is a plus
General Position Summary/Purpose:
This is a new position/schedule. workers should be available to work on rotating shift every week due to 24/7 new business operation. final schedule still under revision.
During routine operations, the Associate SVP Quality Analyst is responsible for carrying out Manufacturing Quality Assurance functions within the ABL plant including performing Line Inspections, Quality Visual Inspections and Tub Hold management process. The incumbent supports the visual inspection certification process, resolution of deviations, participating in investigations, and assurance of compliance with cGMP and Client policies for the manufacturing plant.
Key Accountabilities/Core Job Responsibilities:
• Responsible for performing the SVP Line Inspections, Quality Visual Inspection (i.e. AQL) and provide support for the Tub Hold Management process.
• Supports Visual Inspection Certification Process. May act as Subject Matter Expert (SME) for the Visual Inspection Process.
• Support quality goals ensuring that all practices and procedures comply with GPO and Corporate policies and applicable regulations for the Quality areas under his/her responsibility.
• Support SVP Media Fill Program and QA Oversight execution activities.
• Place product on QA hold when required. Maintains an effective liaison and cooperative relationship with other Quality areas and Plant departments.
• Revise standard operating procedures; ensures procedures comply with Client policies and cGMP guidelines.
• Demonstrates accountability and responsibility of EHS performance and compliance
Additional requirements that we are looking for are:
• Aseptic processing experience
• Quality Assurance experience
• Visual inspection of parenteral products experience
• Participation and/or experience in Aseptic Process Simulation (Media Fills)
• Prior experience/certification in sterile gowning
• Prior experience in surveillance of aseptic filling process is a plus
Qualifications
Education, Qualifications and Experience Requirements (degree, certifications, etc.):
Education: Bachelor degree in biotechnology/biopharma, biology, chemistry or engineering. Pharmaceutical experiences can be considered. Master degree is not needed. at least 1 year biotechnology/biopharma with aseptic processing experience is desired.
Daily Work Schedule Expectations Rotating shift and weekend – All candidates must be available to work any shift including weekend, based in business needs.
Interviews:
How many rounds of interviews? 1 round
Who will be involved in the interview process? Ingrid Boneta / Panel Interviews
Type of interview (video, phone or onsite)?
On site preferred interviews or video interviews if needed (evaluation will be case by case)
Source : Artech LLC