Location: Juncos, PR
Pay Rate: $30.00 p/h

Summary:

• Under general supervision, responsible for one or more of the following activities in Quality Control including analytical testing, characterization, method development, and sample and data management.

Duties and Responsibilities:

• Perform routine laboratory procedures*
• May perform aseptic aliquot ting, sampling and analysis for compendia and non-compendia methods*
• May perform non-routine lab procedures under close supervision*
• Perform or review one or more of the following: sample testing, standards preparation and testing procedures, compendia and non-compendia test methods, environmental monitoring, reagents and solutions preparation, sample management and equipment maintenance*
• Prepare complete, accurate, concise laboratory documentation*
• Data entry, review, analysis and communication of results*
• Perform general lab housekeeping
• Maintain/operate specialized equipment*
• Participate in the document revision process
• Comply with safety guidelines, cGMPs and other applicable regulatory requirements*
• Maintain training proficiency*
• Plan and perform routine analyses with greater efficiency and accuracy*
• May provide technical guidance.
• Plan and perform multiple, complex routine/ non-routine methods and procedures and a large variety of assays*
• Report, evaluate, back-up/archive, trend and approve analytical data*
• Troubleshoot, solve problems and communicate with stakeholders*
• Initiate and/or implement changes in controlled documents
• May train others as necessary
• Participate in audits, initiatives and projects that may be departmental or organizational in scope
• Write protocols and perform assay validation and equipment qualification/ verification
• Introduce new techniques to the lab, including method transfers, reports, validations and protocols*
• May contribute to regulatory filings
• May conduct lab investigations as necessary*
• Evaluate lab practices for compliance on a continuous basis*
• Approve lab results*
• May represent the department/organization on various teams
• May interact with outside resources
• ** Other functions may be assigned

Knowledge:

• Understanding and application of principles, concepts, theories and standards of technical/scientific field
• Specialized knowledge within own specialty area
• Deepens technical knowledge through exposure and continuous learning
• Knowledge of related regulatory/industry considerations, compliance issues and/or scientific discovery

Problem Solving:

• Applies research, information gathering, analytical and interpretation skills to problems of diverse scope.
• Ensures compliance within regulatory environment.
• Develops solutions to technical problems of moderate complexity.
• Screens, categorizes, evaluates, reconciles, reports and resolves data integrity issues.
• Interprets generally defined practices and methods.

Autonomy:

• Works under general direction.
• Work is guided by objectives of the department or assignment.
• Refers to technical standards, principles, theories and precedents as needed.
• May set project timeframes and priorities based on project objectives and ongoing assignments.
• Recognizes and escalates problems.

Contribution:

• Contributes to work group/team by ensuring the quality of the tasks/services provided by self.
• Contributes to the completion of milestones associated with specific projects or activities within own department or workgroup.
• Provides training/guidance to others and acts as a technical/scientific resource within work group/team.
• Establishes working relationships with others outside area of expertise.

Requirements

• Master's degree OR Bachelor's and 6 months of quality work experience OR Associate's and 2 years of quality work experience OR High school and 4 years of quality work experience.
• Availability to work all shifts, overtime, weekends, and holidays. 
• Comprehension of English language. 
• Computer proficiency.

Preferred Qualifications:

• Experience in LIMS, LMES, Empower, GMP documentation or analytical testing execution.
• Experience in Laboratory testing: Wet Chemistry, Microbiology/Endotoxin, Gels, Immune Assays, etc.
• Ability to understand, apply, and evaluate basic chemistry, biology, physical principles and mathematics.
• Ability to adhere to regulatory requirements, written procedures and safety guidelines.
• Ability to evaluate documentation/data according to company and regulatory guidelines.
• Ability to organize work, handle multiple priorities and meet deadlines.
• Demonstrated written and oral communication skills.
• Technical writing capabilities.
• Presentation capabilities.
• Detail oriented.
• Flexible and adaptable to changing priorities and requirements.
• General understanding of Company products and Quality Control operations.
• Ability to interact with inspectors (internal and external).
• Demonstrate understanding of regulatory requirements, safety guidelines and factors impacting compliance.
• Developing project management skills.
• Writes effective science-based quality and compliance documents.
• Presentation and facilitation skills.
• Identifies and explores alternative solutions and effectively weight the elements that are critical to product quality, safety and compliance.
• Applies scientific understanding and methodology experience for effective data analysis.
• General understanding of client operations and processes.
• Demonstrates understanding of when and how to appropriately escalate.

 

 


At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $30.00/hr.