Specialist Quality Control

Ultimate Solutions•Puerto Rico, PR

14d

About The Position

Ultimate Solutions Corp. is a trusted provider of packaging industrial automation, serialization and compliance for the Life Science Industries in Puerto Rico, United States and Europe. Over 2 decades, the Ultimate team has delivered proven results in hundreds of projects and thousands of service hours to the global leaders of pharmaceutical, biotechnology, medical devices and logistics markets. DESCRIPTION Under general direction, functions as the technical specialist for testing and development in areas of molecular biology and microbiology. Focus is on the complex technical issues and scope is typically multi-organizational and/or multi-site and /or involving outside resources. EDUCATION Doctorate degree or master’s degree in Sciences and 2 years of directly related experience or Bachelor’s degree in Sciences and 4 years of directly related experience. REQUIREMENTS FUNCTIONS Responsible for providing technical guidance, Provide reports, data analysis and ensure flow of communication between technical groups including following up on and resolving issues that arise. Resolve technical issues and troubleshoot for assays as necessary Ensure lab compliance which includes: Implementing procedures that enhance GMP, GLP and safety. Manage existing and/or develop and implement new programs, processes and methodologies. Develop, revise and audit various complex controlled documents that may have multi-organizational and/or multi-site impact. Approve lab investigations, Lead audit teams May serve as subject matter expert to develop technical training. May perform routine work in a specific area of responsibility as necessary. Represents the department/organization on various teams, Independently responsible for following through on multi-site action items. May interact with regulatory agencies regarding area(s) of responsibility including written responses. May resolve issues with outside resources. Performs special projects as requested by supervisor, May supervise employees as necessary to meet technical requirements. SKILLS Excellent communication skills, facilitation and presentation skills. Excellent technical writing skills. Scientific Data Analysis Strong Technical Writing (English and Spanish) mainly focuses Strong knowledge in Microsoft Excel as a Tool for Data Analysis Good Communication skills Project Management Knowledge in Computer System and Method Validation (Experience preferable) Strong knowledge and experience with quality process management Knowledge on equipment validation and troubleshooting (Experience preferable) Agile on prioritization of critical tasks Ability to develop inspection or qualification protocols in a short timeframe period. Strong negotiation skills Usage of KNEAT platform and Kaye validator (Experience Preferred) Ultimate Solutions Corp is an Equal Opportunity Employer.

Requirements

Doctorate degree or master’s degree in Sciences and 2 years of directly related experience or Bachelor’s degree in Sciences and 4 years of directly related experience.
Excellent communication skills, facilitation and presentation skills.
Excellent technical writing skills.
Scientific Data Analysis
Strong Technical Writing (English and Spanish) mainly focuses
Strong knowledge in Microsoft Excel as a Tool for Data Analysis
Good Communication skills
Project Management
Strong knowledge and experience with quality process management
Agile on prioritization of critical tasks
Ability to develop inspection or qualification protocols in a short timeframe period.
Strong negotiation skills

Nice To Haves

Knowledge in Computer System and Method Validation (Experience preferable)
Knowledge on equipment validation and troubleshooting (Experience preferable)
Usage of KNEAT platform and Kaye validator (Experience Preferred)

Responsibilities

Responsible for providing technical guidance
Provide reports, data analysis and ensure flow of communication between technical groups including following up on and resolving issues that arise.
Resolve technical issues and troubleshoot for assays as necessary
Ensure lab compliance which includes: Implementing procedures that enhance GMP, GLP and safety.
Manage existing and/or develop and implement new programs, processes and methodologies.
Develop, revise and audit various complex controlled documents that may have multi-organizational and/or multi-site impact.
Approve lab investigations
Lead audit teams
May serve as subject matter expert to develop technical training.
May perform routine work in a specific area of responsibility as necessary.
Represents the department/organization on various teams
Independently responsible for following through on multi-site action items.
May interact with regulatory agencies regarding area(s) of responsibility including written responses.
May resolve issues with outside resources.
Performs special projects as requested by supervisor
May supervise employees as necessary to meet technical requirements.