Position Summary:

Glenmark is actively seeking a Quality Systems Coordinator to join the growing team in Monroe, NC. The Quality Systems Coordinator reports to the Senior Manager, Quality Systems and Compliance and is responsible for managing the coordination, investigation and resolution of Quality Systems notifications including, but not limited to, complaints, change controls, incidents, deviations, corrective and preventative actions, and quality aspects of field alerts and recalls. This individual works closely with cross-functional teams at the site and abroad. This individual will routinely report on quality system and business process performance; proactively identifying, providing guidance and implementing process and system improvements to resolve complex issues in a timely manner.

Responsibilities include but are not limited to:

* Ensures complaints and quality systems notifications are logged, triaged, investigate
* Coordinates with cross-functional teams for testing of reserve or retain samples for investigation purposes where applicable.
* Coordinates/inputs data for Quality into Electronic Quality Management system.
* As part of complaint investigations, reviews relevant records, (e.g. batch records, quality control data, quality notifications, etc).
* Tracks quality system metrics and creates detailed trend analysis reports.
* Conducts root cause analysis in order to facilitate and initiate corrective and preventative actions wherever.
* Prepares formal reports for complaint responses.
* Performs analysis of data, trending and provides metrics for Quality Systems, as required.
* Ensures complaints and quality systems notifications are logged, triaged, investigated, and resolved according to established deadlines, company and regulatory requirements.
* Coordinates with cross-functional teams for testing of reserve or retain samples for investigation purposes where applicable.
* Coordinates/inputs data for Quality into Electronic Quality Management system.
* As part of complaint investigations, reviews relevant records, (e.g. batch records, quality control data, quality notifications, etc).
* Tracks quality system metrics and creates detailed trend analysis reports.
* Conducts root cause analysis in order to facilitate and initiate corrective and preventative actions wherever.
* Prepares formal reports for complaint responses.
* Performs analysis of data, trending and provides metrics for Quality Systems, as required.
* When required, support coordination and tracking of all Quality Systems and Compliance functions, including, but not limited to, complaints, annual product review, field alerts, recalls, change controls, incidents, deviations, and audits.
* Understand current requirements and keep quality systems up-to-date on any and all changes to GxP, internal/external regulations and procedures.
* Support inspection processes, including, but not limited to, governmental, regulatory, corporate or vendor audits and audit readiness activities.
* Support internal and external/regulatory audits when required.
* Recognize and escalate significant complaints and quality issues to Management and interface with various functional departments to manage and resolve significant notifications.
* Develop and Revise various SOPs/Work Instructions/Documents as necessary to ensure compliance, efficiency and clarity.
* Initiate and participate in process improvement activities.
* Establish Key Performance Indicators (KPIs) for functional area and ensure systems are operating within target.

Education:

* Minimum Associates degree in scientific discipline (or closely related technical field of study).
* Minimum of five years experience in Quality Assurance or Quality Control, in the pharmaceutical, biopharmaceutical, or medical device industries handling complaints or a combination of education and experience.

Experience:

* Minimum of five years experience in Quality Assurance or Quality Control, in the pharmaceutical, biopharmaceutical, or medical device industries handling complaints or a combination of education and experience.
* MasterControl experience preferred.
* SAP experience preferred.
* Prior pharmaceutical manufacturing experience preferred.

Knowledge & Skills:

* Strong understanding of current GMPs and related regulatory health authority guidance (FDA regulations, ICH guidelines, etc.) as they relate to the pharmaceutical industry.
* Must be proactive, results-oriented with a strong attention to detail and strong time management skills.
* Ability to manage multiple projects simultaneously, meet deadlines, and handle an ever-changing, fast-paced critical work environment.
* Strong organizational, analytical, troubleshooting and problem-solving skills, specifically related to Quality Assurance.
* Ability to analyze details and perform structured decision-making on a daily basis.
* Excellent verbal and written communication/documentation skills. Must be able to read, write, and speak English.
* Strong interpersonal skills with ability to interact with all levels of personnel in a professional manner.
* Intermediate Excel and/or Minitab skills are required including, but not limited to, spreadsheet manipulation, charting, analyses tools.

Leadership/Managerial Attributes

* Ability to work independently, or within a team structure, and on multiple projects, with flexibility to adapt to changing priorities is required.
* Self-starter with the ability to work independently with minimum supervision and use good judgment, or as a contributing member of a team.

Other Requirements (licenses, certifications, specialized training):

* Any quality or lean/Six Sigma certifications are a plus.

Our Company is an Equal Opportunity Employer committed to fostering diversity in the workplace, both in its employee workforce and in Company leadership. (minorities/females/veterans/individuals with disabilities/sexual orientation/gender identity)

Quality Systems Coordinator

First-Line Supervisors of Production and Operating Workers (51-1011.00)

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