QA Technician I, Documentation Systems

Our Company
Akorn, Inc. is a niche pharmaceutical company that develops, manufactures and markets generic and branded prescription pharmaceuticals as well as animal and consumer health products. We specialize in difficult-to-manufacture sterile and non-sterile dosage forms including: ophthalmics, injectables, oral liquids, otics, topicals, inhalants, and nasal sprays. Akorn markets its products to retail pharmacies, ophthalmologists, optometrists, physicians, veterinarians, hospitals, clinics, wholesalers, distributors, group purchasing organizations, and government agencies.

Summary
Revise and maintain controlled documents including, but not limited to: Master Batch Records, Standard Operating Procedures, Active Pharmaceutical Ingredient Specifications, Finished Drug Product Specifications, Forms, and Protocols. Maintain and distribute Document Change Requests. Provide coverage for Front Desk.

Essential Functions
Include the following. Other duties may be assigned.
1. Develop, generate, track and issue revisions to controlled documents.
2. Assign numbers, route and track Document Change Requests.
3. Revise appropriate section of monthly Performance Metrics.
4. Review numbered batch records prior to issuance to production.
5. Scan and file approved controlled documents. Maintain history files of superseded and obsolete revisions.
6. Issue numbered product and sanitization solution batch records to production.
7. Scan, bind and file released batch records.
8. Create production labels daily for filling, autoclave, rejects and re-boxing.
9. Responsible for reconciliation of labels after batch is filled.
10. Answers and directs phone calls at the switchboard.
11. Monitors front gates and security cameras.
12. Greets and directs all visitors and customers to the facility.
13. Sorts and distributes all incoming and interoffice mail.
14. Schedules and arrangements for meetings and working lunches as requested by management.
15. Box and transfer documents to the Wyckles document room as needed.

Additional Responsibilites
1. Break relief / substitute in absence of plant receptionist.
2. Assist in maintenance of Wyckles Document Room.
3. Assist with scanning, binding and filing of released batch records, investigations, document change requests, and other documents as needed.
4. Updates and maintains MSDS books and logs.

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.
1. Working knowledge of Microsoft Office programs.
2. Detail-oriented.

Education and Experience
One year certificate from college or technical school; or three to six months related experience and/or training; or equivalent combination of education and experience.

Job Prerequisites
Ability to meet attendance standards. All full-time employees are required to work a 40-hour week, most of which has to be during "regular" business hours. At times it may be necessary to work additional hours in order to get the required tasks accomplished to meet deadlines.

Physical Demands and Work Environment
While performing the duties of this job, the employee is regularly required to sit, stand, walk, talk and hear. The employee is required to use hands to finger, handle or feel. Specific vision abilities required by this job include close vision for written work and PC use. Additional physical requirements include the ability to hear accurately the spoken word with moderate office noise (or plant noise).

Mental requirements include:
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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