Associate Quality Control

Location: Juncos, PR
Pay Rate: $21.01 / Hourly
Schedule: Available for 2nd shift, holidays, weekends, as per business needs (1st. 2nd, 3rd and 12-hour shift, if needed).

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.
• May participate in lab investigations/ audits.
• Maintain training proficiency.
• May approve lab results.
• Knowledge of basic principles, methods, and practices of technical/ scientific field.
• Typically obtained through formal study.
• General knowledge of procedures and activities within own work area.
• Ability to relate day-to-day work to business priorities.
• General understanding of industry practice and standards.
• Applies broad-based research, information gathering and analytical skills to factual information.
• Selects appropriate alternatives from defined options.
• Collects required documentation/raw data; verifies conformance of documents.
• Assesses accuracy of detailed information.
• Tracks, maintains, and produces regular work products.
• Ability to identify roadblocks to task completion and effectively brings them to line managers for resolution.
• Works under general direction, seeks assistance as needed.
• Completes work in accordance with established procedures and practices within field of technical/scientific knowledge.
• Establishes approaches for completing assignments.
• Work requires consistent exercise of discretion and independent judgment.
• Works with team to support achievement of project milestones.
• Contributes to own work group/team through quality and accuracy of own output.
• Builds productive internal/external relationships.

Qualifications:

• High school/GED + 2 years of directly related work experience OR Associate’s with + 6 months of directly related work experience OR Bachelor of Science in Biology, Chemistry, Mechanical Engineering, Chemical Engineering with no experience.
• Hands-on understanding of microbiological quality control processes, strong adherence to SOPs and regulatory compliance standards, and experience supporting contamination control and laboratory documentation practices.
• Strong knowledge and understanding of GMP, regulatory requirements, written procedures, methods and safety guidelines.
• Basic knowledge and experience in sampling and inspection processes raw material, components, drug substance, drug product and devices per procedures and regulations.
• Strong skills in systems such as SAP/ERP, eBR, LIMS, Trackwise, Coldstream, Veeva and applications such as Smartsheet among others.
• Intermediate proficiency with Microsoft Office (Word, Excel, PowerPoint, databases) 
• Strong verbal and written communication skills, presentation skills. 
• Ability to work in a team environment, to collaborate and coordinate with internal and external staff at all levels, and to prioritize multiple responsibilities, tasks, and projects simultaneously.
• Strong verbal and written communication skills
• Flexibility to support non-standard shifts, including weekends.

 
 
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.The pay rate for this position is $21.01/hr.