Quality Control Laboratory Specialist

Location: Manati, PR
Hours: Sunday-Thursday/Tuesday-Saturday (2:00-10:30PM)

Position Summary
The Specialist in this role will be responsible for executing routine testing of complex and non-complex methods on intermediate or finished products a, environmental monitoring, utility testing, raw materials, etc. as appropriate for the individual role. They will also support lab operations activities such as housekeeping, as required.

Key Responsibilities:

• Ensure all Quality Management System (QMS) records are maintained and updated in accordance with established procedures and regulatory requirements.
• Assist in the validation and decommissioning of equipment, ensuring all activities comply with regulatory standards and company protocols.
• Executes routine testing of non-complex/compendial methods, environmental monitoring, utility testing, raw materials etc., as appropriate for the individual role
• Perform release/stability testing for complex and non-complex methods on intermediate or finished product
• Perform activities to support lab operations such as housekeeping, alarm acknowledgment, reagent preparation, inventory management, material and reagent ordering, sample pickup and discarding, and execution of work orders.
• May represent the department during regulatory inspections (or internal and external audits).
• Provides input into scheduling of assignments by the team lead / manager.
• Perform data verification and review
• Records performance metrics
• May update QC documents for managerial review and approval.
• May lead simple projects within the team. Also contributes to complex projects.
• May train colleagues in the execution of tasks and testing
• Contributes to change controls
• Supports deviation investigations and laboratory investigations through data gathering or interview process. May lead no impact deviations.
• Identifies and escalates challenges & barriers to execution, suggests solutions, and participates in remediation.
• Identifies and escalates method and/or instrument issues. Also supports and may lead solutions.
• Positive, supportive, and actively collaborates within the team.
• Actively and positively learns and participates in Operational Excellence (OpEx) and Continuous Improvement (CI) initiatives in the team.
• Complete all required tasks compliantly and safely while consistently and intentionally modeling BMS values (Integrity, Accountability, Passion, Urgency, Innovation, and Inclusion).
• Perform other tasks as assigned.

Qualifications & Experience

• Bachelor’s Degree in a Scientific or relevant technical area with 1 year experience OR Master’s degree in a Scientific or relevant Technical area.
• Ability to understand and follow procedures.
• Ability to work in a fast-paced team environment, meet deadlines, and prioritize work.
• Ability to communicate effectively with peers and management regarding task completion, roadblocks, and needs.
• Attention to detail and demonstrate organizational skills.
• Ability to manage multiple assignments while meeting timelines.
• Knowledge of basic electronic systems (email, MS Office, etc.) and lab data systems (e.g. LIMS) required
• Ability to interpret and apply cGMPs, Compendia regulatory requirements and industry best practices.
• Excellent organizational and critical thinking skills.
• Is considered a fully independent analyst capable of executing tasks with no supervision
• Problem-solving ability/mentality, technically adept and logical.
• Ability to write technical documents.

 

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: $26.78/hr.