Avantor · 20 hours ago

Quality Control Supervisor

Solon, OH

Full-time

Onsite

Senior Level

5+ years exp

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Responsibilities

Directly supervises the quality control staff, monitor individual skills and abilities for most efficient operation; follow progress of work; anticipate or investigate delays or inadequate performance; take corrective action within limits of established practice; provide assistance to other departments as needed.

Provides on-the-floor and technical support to quality control associates.

Supports and enforces the quality system, regulatory policies, and work instructions.

Maintains quality and quantity of output; arranges for equipment, materials, and supplies to be available for work assignments; ensures that equipment is given proper care; troubleshoots faulty operations to determine cause and arranges for required repair and maintenance.

Provides or arranges for training and cross-training to employees in the performance of duties; assists and instructs personnel as necessary to ensure proper flow of work through the department.

Provides guidance to all level Technicians including test methods, analytical technique, good laboratory practice, paperwork completion, equipment, schedule interpretation, and LIMS support.

Reviews and approves controlled Quality Control documents including but not limited to specifications, procedures, work instructions, validation protocols, and validation reports.

Ensures department documents and procedures are up to date and reflect current practice; revising procedures & processes when needed.

Performs investigations for laboratory out-of-specification results, safety-related incidents, and/or processes related to the QC laboratory.

Works with customers, regulatory agents, and vendors during audits and site visits.

Understands regulatory requirements for 21 CFR820, GLP, GMP including USP/EP general practices and procedures.

Proactively maintains current industry and regulatory knowledge for medical devices, GMP principles, and current analytical technology.

Assists in determining the priority of urgent items and appropriate action plan to effectuate priority.

Approves rejections and rework actions as recommended by Quality Control Technicians.

Enforces prescribed safety rules and regulations; ensures that work areas are maintained in a neat and orderly condition; performs safety and security procedures to open and close buildings and facilities.

Performs other duties as assigned.

Qualification

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Lab ExperienceSupervisory ExperienceMS OfficeIssue ResolutionInterpersonal SkillsOrganizational SkillsTeamworkProblem-SolvingDecision-MakingLeadershipAttention to DetailCommunication Skills