Location: Juncos, PR

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

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 analyzes 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

Requirements:

• High school/GED + 4 years of Quality work experience OR  Associate’s + 2 years of Quality work experience OR Bachelor’s + 6 months of Quality work experience OR Master's
• Ability and willingness to work any shift in support of operations that may include 24/7. Availability to work non-standard shifts, holidays, weekends, as per business needs.
• GMP Documentation
• Data Integrity
• Quality Systems ( CAPA, Change Control, Deviation, etc..)
• Computerized Maintenance ( Asset / PM creation, Documentation, etc..)
• Validation Maintenance ( Periodic Review, Periodic Monitoring, etc..)
• Good Written and Communication Skills.
• 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.

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.

 

About Us: Established in 2004, SPECTRAFORCE® is one of the largest and fastest-growing diversity-owned staffing firms in the US. The growth of our company is a direct result of our global client service delivery model that is powered by our state-of-the-art A.I. proprietary talent acquisition platform, robust ISO 9001:2015/ISO 27001 certified processes, and strong and passionate client engaged teams. We have built our business by providing talent and project-based solutions, including Contingent, Permanent, and Statement of Work (SOW) services to over 140 clients in the US, Canada, Puerto Rico, Costa Rica, and India. Key industries that we service include Technology, Financial Services, Life Sciences, Healthcare, Telecom, Retail, Utilities and Transportation. SPECTRAFORCE is built on a concept of “human connection,” defined by our branding attitude of NEWJOBPHORIA®, which is the excitement of bringing joy and freedom to the work lifestyle so our people and clients can reach their highest potential. Learn more at: http://www.spectraforce.com

Benefits: SPECTRAFORCE offers health benefits that include vision, dental, and pharmacy. Additional benefits offered to eligible employees include a 401K retirement plan with employer matching, a referral bonus program, and an EAP (Employee Assistance Program). SPECTRAFORCE provides unpaid leave as well as paid sick leave and vacation when required by law.

Equal Opportunity Employer: SPECTRAFORCE is an equal opportunity employer and does not discriminate against any employee or applicant for employment because of race, religion, color, sex, national origin, age, sexual orientation, gender identity, genetic information, disability or veteran status, or any other category protected by applicable federal, state, or local laws. Please contact Human Resources at benefits_pr@spectraforce.com if you require reasonable accommodation. 


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.