Job Description

Job Descriptions

Position Overview

The Senior Quality Control Supervisor will have quality oversight over reagent and consumable product testing for In Vitro Diagnostics (IVD) products. This position is a unique opportunity to develop the quality processes and infrastructure required to deliver products to the international market. This role is primarily responsible for assessing whether product quality conforms to requirements and establishing quality processes, including but not limited to test methods, lab setup & maintenance, incoming/in-process/finished goods testing, out of specification management, nonconformities, CAPAs, and technical investigations as needed. This individual is responsible providing technical expertise, and teaching and coaching others on IVD and MD quality requirements.

Key Responsibilities

* Assure that the site has policies, processes and procedures in place so that site activities, with regards to quality control testing so that product, to meet applicable quality and regulatory standards.
* Supports the development, manufacture and delivery of quality and compliant products on time to meet the needs of the business and customers
* Works closely with the Technical, Engineering, and Research & Development functions in order to ensure that test methods are developed and executed in compliance with Corporate and cGMP requirements, and in a timely manner to ensure business goals are met.
* Responsible for QC oversight, including the supervision of contract QC operators, lot sample retains, standards and calibrators, quality control documentation and product andmaterial disposition. Investigates out of specification events and supports other investigations (eg. root cause, complaints).
* Ensures non-conforming product is identified and appropriately controlled, and associated processes are initiated. Reviews and provides guidance for various non-conforming situations and investigation activities, evaluates root cause and corrective actions, and ensures documentation is complete and accurate.
* Defines and implements Quality System documentation, including Testing Plans, Protocols, work instructions, templates, release processes, out of specification events, nonconformances, CAPA and associated investigations, and appropriately dispositions affected materials. Performs disposition of manufactured materials and products, assuring product quality is in compliance with Quality System regulations.
* Participates in auditing of manufacturing activities and Internal Audits. Provides guidance for investigations of discrepancies or failures related to manufacturing and control systems.
* Participates in project work and initiatives associated with Quality System issues in conformance to regulatory requirements. Interfaces and provides Compliance guidance/support to Operations and Development functions. Participates in the design and implementation of Quality improvement activities.
* Leads laboratory equipment and test method validation to ensure that test strategies are capable of meeting their intended purpose.
* Maintains the metrics required to monitor the compliance of quality control processes and escalates issues when necessary.
* Helps to implement an electronic quality management system
* Other tasks as required by the business.

Required Knowledge/Skills, Education, and Experience

BS/BA in Biology, Chemistry, Biochemistry, Microbiology, or Bioscience, or advanced degree, where required, or equivalent combination of education and experience.

Demonstrates and applies a broad knowledge of field of specialization through successful completion of moderately complex assignments. Successfully applies complex knowledge of fundamental concepts, practices, and procedures of particular area of specialization. Demonstrates knowledge of organization's business practices and issues.

Prior successful demonstration of:

* Development of test methods for regulated quality control activities (5+ years) required to meet core quality objectives
* Completion of laboratory procedures within a Quality Management System (5+ years) required to understand and promote quality standards.
* Project Management through leading cross functional teams (3+ years) required to manage group activities.
* Working knowledge required of regulations and standards affecting in-vitro diagnostics (IVD) and medical devices (MD), such as FDA QS Regulations Part 820 & Part 11, ISO13485, ISO14971 and cGMP, highly preferred.
* The ability to work effectively across a matrixed organizational structure and be a team player is a key requirement. Agile and flexible team player.
* Able to effectively manage short term and long-term deadlines.
* Excellent written, negotiation and oral communication skills.
* Excellent working knowledge of English grammar and punctuation.
* Receptive to change and be able to drive change.
* Any formal certification in the area of cGMP, Quality management, and/or design/manufacturing process validation is highly desirable.
* Experience with Molecular Diagnostics is highly desirable.

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