QA Manager, Documentation

Akorn, Inc. Decatur , IL 62523

Posted 1 week ago

Job Description:

SUMMARY:

Manages, implements and coordinates the documentation program to oversee creation of Master Batch records, specifications, SOPs, issuing of batch records, logging, tracking and trending of deviations, out-of-specifications, non-lab out-of specifications, corrective and preventative actions (CAPA), handling investigations of complaints and other activities to assist in the management and quality oversight of the company.

ESSENTIAL FUNCTIONS:

Include the following. Other duties may be assigned.

  • Oversee all aspects of document control for Decatur operations as well as limited management of documentation control for the Skokie, Lake Forest and Gurnee operations.

  • Manage databases for all document systems and metrics reporting.

  • Evaluate personnel requirements of the Documentation department.

  • Supervise QA clerical staff responsible for documentation (i.e. batch records, SOPs, DCRs, specifications).

ADDITIONAL RESPONSIBILITIES:

  • Assist during FDA inspections pertaining to documentation, CAPA, discrepancies and trending of quality matrices.

Qualifications

QUALIFICATIONS:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

  • Proficient with computer programs.

  • Five years of previous quality experience, with supervisory experience.

EDUCATION AND EXPERIENCE:

High school diploma or equivalent and a minimum of five years experience in related job function. Experience in a supervisory role required.

JOB PREREQUISITES:
1.Ability to meet attendance standards. All full-time employees are required to work a 40-hr week. At times it may be necessary to work additional hours in order to get the required tasks accomplished to meet deadlines.
2.Excellent communication skills.
3.Strong attention to detail.
4.Ability to supervise personnel

PHYSICAL DEMANDS, MENTAL REQUIREMENTS, AND WORK ENVIRONMENT:

Requires prolonged sitting. Requires eye-hand coordination and manual dexterity, normal range of hearing and vision to record, prepare and communicate appropriate reports. Specific vision abilities required by this job include close vision for written work and PC use. The noise level is usually fairly quiet.

Mental Requirements include:

  • Ability to hear accurately the spoken word with moderate office noise or plant noise

  • Ability to apply deductive reasoning and understand complicated issues

  • Ability to receive instructions and follow work rules and company policies

  • Ability to follow safety and security practices

  • Ability to meet deadlines and effectively deal with office stress

  • Ability to accurately communicate ideas, facts and technical information

  • Maintain confidentiality of certain information

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QA Manager, Documentation

Akorn, Inc.