Lead QA Coordinator Document Control Training

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SUMMARY DESCRIPTION

The Lead QA Coordinator Doc Control/ Training manages the Document Control & Training Management processes and maintains associated procedures in accordance with FDA 21 CFR Part 820 ISO 13485 state and local regulations and Integra policies and procedures.

SUPERVISION RECEIVED

Minimum supervision from Manager QA

SUPERVISION EXERCISED

0

ESSENTIAL DUTIES AND RESPONSIBILITIES

• Acts in the capacity of Agile Analyst
  • Manages Change Control ECR/ ECO processes
  • Manages the Document Control DCO process.
  • Owns the Deviation process. Reviews Deviations prior to their approval releases Deviation as effective and closes Deviations in coordination with the Deviation owners.
• Is a point of contact with MasterControl
  • Communicate with MasterControl support for technical issues.
  • Enter maintain and archive users in the MasterControl system and provide support as needed.
• Acts as administrator for Training and Competency program
  • Organize Implement and update training competency program and Training Job codes.
  • Maintain employee training records (hard or electronic) and ensure that training files are current.
• Based on the Work Orders printed and provided by the Manufacturing:
  • Prints corresponding Job Travelers from Agile.
  • Prints corresponding IFUs from Agile or gets preprinted IFUs.
  • Applies Master Stamp on printed Job Travelers and IFUs and makes them available to manufacturing.
• Writes and reviews QMS SOPs as necessary.
• Administers elements of the site quality system in relationship to the corporate quality system and makes revisions as needed.
• Conducts trend analysis of QA activities and other quality indicators as needed.
• Ensures all document control quality records are appropriately filed and easily retrievable in the quality department and/ or Agile/ Master Control software.
• Performs other related duties as assigned.

REQUIRED SKILLS & KNOWLEDGE

The requirements listed below are representative of the knowledge skill and/or ability required for this position.

Education & Experience:

• Education/ Experience:
  • Bachelors degree or equivalent in a related scientific discipline with 0 2 year of relevant work experience; or
  • Associate degree or equivalent in a related scientific discipline with 3 5 years of relevant work experience; or
  • High School degree or equivalent with a minimum of 5 years of relevant work experience
• Well informed and proficient in the use of modern technology especially Electronic Document Management systems (EDMS) Enterprise Resource Management Systems (ERP) and the Microsoft suite of applications.
• Experience in MasterControl Agile and Oracle systems is highly preferred.
• Demonstrated knowledge of cGMP ISO 13485 and other national and international regulations and standards.
• Strong communication skills both written and verbal.
• Selfmotivator with an analytic nature. Strong organizational communication and interpersonal skills.
• Teamfocused attitude.
• Ability to obtain Quality training and/or certifications as needed.
• Organized attention to detail and excellent analytical skills.
• Excellent communication skills both written and verbal.
• Excellent organization prioritization and problemsolving skills
• Able to lift 40 lbs.

TOOLS AND EQUIPMENT USED

Ability to utilize a computer telephone fax and copy machine as well as other general office equipment.

PHYSICAL REQUIREMENTS

The physical requirements listed in this section include but are not limited to the motor/physical abilities and skills required of the position in order to successfully undertake the essential duties and responsibilities of this position. In accordance with the Americans with Disabilities Act (ADA) reasonable accommodations may be made to empower individuals with disabilities to undertake the essential duties and responsibilities of the position.

While undertaking the essential duties and responsibilities of the position the employee must repeatedly sit listen speak type and move throughout the facility. The employee is required to go to all areas of the company. Must be able to independently travel via car or airplane to domestic and international locations as needed.

ADVERSE WORKING CONDITIONS

The adverse working conditions listed in this section include but are not limited to those environmental conditions to which the employee may be exposed while undertaking the essential duties and responsibilities of this position which is that of a general plant environment.

While performing the duties of this job the employee is occasionally exposed to moving mechanical parts fumes or airborne particles high precarious places toxic or caustic chemicals risk of electrical shock and vibration. The noise level in the work environment is usually moderate

There are no adverse working conditions associated with this position.

SELECTION GUIDELINES

Formal application rating of education and experience; oral interview and reference check; job related tests may be required.

DISCLAIMER

The duties listed above are intended only as illustrations of the various types of work that may be performed. The omission of specific statements of duties does not exclude them from the position if the work is similar related or a logical assignment to the position.

The job description does not constitute an employment agreement between the employer and employee and is subject to change by the employer as the needs of the employer and requirements of the job change.

Integra LifeSciences is an equal opportunity employer and is committed to providing equal employment opportunities to all qualified applicants and employees regardless of race marital status color religion sex age national origin sexual orientation physical or mental disability or protected veteran status.

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Integra LifeSciences is committed to provide qualified applicants and employees who are disabled veterans or individuals with disabilities with needed reasonable accommodations in accordance with the ADA. If you have difficulty using our online system due to a disability and need an accommodation please email us at or call us at.

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