Associate Quality Control

Location: Juncos, PR
Pay Rate: $21.01 / Hourly

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 + 6 months of directly related work experience OR Bachelor’s in Biology, Chemistry, Mechanical Engineering, Chemical Engineering, etc.
• 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.
• Perform routine sampling and inspection of raw materials, components, devices, drug substance, drug product and printed materials.
• Operate specialized equipment (i.e., Optical Comparator, Keyence, Nikon, Instron, NIR).
• Performs classified area rooms cleaning/sanitization processes and disinfectant solution preparation.
• Basic skills in systems such as SAP/ERP, eBR, LIMS, Trackwise, Coldstream and applications such as Smartsheet and excel, among others.
• Work closely with Supply Chain Procurement, QA Disposition, Dispensing, Receiving, Shipping and Packaging to ensure daily warehouse operations are well coordinated between each function.
• Perform raw material sample shipments, testing and batch record's review per standard operating procedures or guidelines.
• 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.
• Must be detail oriented.
• Must be flexible and adaptable to changing priorities and requirements.
• General understanding of company products and QAL operations.
• Ability to interact with inspectors (internal and external).

 

 


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: $21.01/hr.