ROLE SUMMARY

The QC Specialist-Lab Equipment serves as a key contributor to manage the Quality Control Chemistry laboratories equipment maintenance program. Primary responsibilities for this role include performing Calibration and Preventive Maintenance (PM) of laboratory equipment, including unscheduled maintenance and service; conducting the out of tolerance/laboratory investigations; conducting periodic reviews and providing or coordinating training on the laboratory equipment and related system software applications.

The QC Specialist (Lab Equipment) will work under general supervision, referring to policies and practices for guidance and follows established procedures. The incumbent operates within established HR policies and basic colleague relations guidelines and contributes to the completion of specific team objectives and assigned project milestones. The successful candidate will be required to drive continuous improvement and maintain a state of regulatory audit readiness over these programs and will demonstrate knowledge and leadership principles.

The QC Specialist (Lab Equipment) also serves as a System Administrator of standalone laboratory computer applications, ensures appropriate Calibration and PM of laboratory equipment to use in the respective areas and determines when equipment requires recalibration. He/she provides technical support to the laboratories for the selection/evaluation of new equipment and action items implementation from trending, Kindeva Quality Standards and Compliance Analysis Status reports, evaluates changes for validated/qualified laboratory equipment or laboratory facilities, and is responsible for approving new or modified Calibration/PM acceptance criteria that impacts the safety, identity, strength, or quality of the product (e.g. validation and/or regulatory commitments). Additional responsibilities will include authoring and supporting SOP revisions, change control requests, reviewing validation/qualification protocols, technical reports, project plans, trend reports, equipment Calibration/PM and procedures, etc.

ROLE RESPONSIBILITIES

• Performs the equipment Calibration/Verification or PM according to the established procedures.
• Reviews the Calibration/Verification or PM data to ensure that the equipment is calibrated according to predetermined schedules and procedures.
• Maintains Calibration/Verification or PM records including certificates of standards along with calibration due list.
• Maintains calibration standards or Test Equipment to support the program.
• Maintains updated records of the Calibration or PM service contractor and approves contractor’s procedures.
• Assures all laboratory equipment procedures are aligned with the current compendia (such as USP/NF, EP or any other regulatory reference) requirements.
• Notifies equipment owner and Quality Assurance of any discrepancy found during maintenance or calibration.
• Assures Laboratory Equipment Master List is maintained and inspection ready.
• Interprets and evaluates data in terms of accuracy, precision, trends and potential cGMP impact and recommends appropriate corrective actions.
• Applies existing techniques and procedures, with recommendations, and implements modifications for improve laboratory efficiency and productivity.
• Coordinate and support laboratory equipment training.
• Demonstrates a complete understanding and wide application of pharmaceutical industry, functional and specific principles, theories, concepts and practices. Focus on leading/overseeing defined processes that may require detailed knowledge.
• Independently determines and develops approach to solutions, provides solutions to a wide range of difficult/complex problems as well as identifying cause and effect relationships.
• Other duties within the quality department as required.

BASIC QUALIFICATIONS

• Bachelor of Science- Chemistry
• 5+ years previous experience in pharmaceutical laboratory operation and laboratory equipment maintenance; operation/calibration/preventative maintenance and leadership are highly desirable
• Knowledge of 21 CFR 210/211
• The incumbent must understand the working principles of common, simple, and complex laboratory equipment, be familiar with special analytical techniques, understand and implement procedures pertinent to laboratory operation/calibration/PM program
• Excellent analytical and investigation skills
• Experience with Empower Chromatographic data system application and instrument specific software applications.
• Fluent in English both speaking and writing

PREFERRED QUALIFICATIONS:

• The successful candidate will have good planning skills, good oral, written and interpersonal communication skills, and basic computer literacy and demonstrate the ability to organize time independently and prioritize workload.
• Preferred candidates will possess expertise of analytical laboratory techniques, laboratory equipment operations/calibration/PM, compendia requirements, chromatography technique, Empower chromatographic data system and technical written skills.
• Experience utilizing Lean, Six Sigma and other continuous improvement methodologies for process improvement is highly desirable.

LI-Onsite

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Equal Opportunity Employer:

Kindeva Drug Delivery is an Equal Opportunity/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, Protected Veteran status, sexual orientation, or any other characteristic protected by federal, state or local law.

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