Quality Systems Specialist II
Akorn 2

SUMMARY:

Revise and maintain GxP documents such as SOPs, Forms, Master Batch Records, Specifications Monographs, Protocols and Logbooks. Facilitate/Process Document Change Request and Change Control Requests. Maintain, secure and ensure compliance by adhering to all local, corporate and regulatory requirements during the lifecycle of the documentation.

ESSENTIAL FUNCTIONS:
Include the following. Other duties may be assigned.

• Review and process Document Change Requests (DCRs) and Change Control Requests (CCRs) for accuracy and completeness while adhering to appropriate regulations, local and corporate standard operating procedures.
• Facilitate and coordinate Change Controls Meetings.
• Coordinate and support the compilation of documents required for regulatory submissions and requests.
• Facilitate/Coordinate/Provide GxP documents and document change control data for change controls, annual product reviews, regulatory submissions and annual reports
• Maintains Change Control HOLDs database affecting BPR implementation.
• Acts as a Liaison with various departments to track and meet target dates to ensure change control request timelines and on time completion of GxP documents.
• Assign tracking numbers and maintain database for DCRs and CCRs through the lifecycle of the documentation.
• Support and Facilitate the Deployment of ERP systems. (Veeva)
• Maintain, issue, review, approve and archive batch records.
• Cooperate transversely with other teams such as Production and Validation to revise and create master batch record templates.
• Maintain, create, issue and archive Controlled GxP Forms and Logbooks.
• Issue Raw Material CoAs to QC Microbiology and QC Chemistry.
• Facilitate/Support other teams in compiling, retrieving and reviewing documents during Mock Inspections, Internal/External corporate audits and Regulatory audits.
• Initiate Investigations and review/complete CAPA’s associated with Documentation Control Group.
• Facilitate and support Continuous Process improvements.
• Provide Metrics (Weekly Metrics, Quarterly Metrics, Corporate Metrics)
• Facilitate on time closures for Biennial reviews.
• Facilitate/Support implementation of an Electronic Document Management System.

• Complete/Facilitate on the Job-Related training while maintaining alignment with GMP practices, safety, ethics and compliance requirements.
• Author and revise Standard Operating Procedures (SOPs)

ADDITIONAL RESPONSIBILITIES:

• Ensure compilation of documents required for regulatory submissions are complete and accurate.

• Scan and file and archive all GxP documents (released batch records, change controls, SOPs, Forms, Monographs, Test Methods, and Protocols)

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.

EDUCATION AND EXPERIENCE:

• Bachelor’s degree (BS) from four year college or university.
• A combination of Education and Experience
• Minimum of 3 year experience in the pharmaceutical industry, in a Quality role/QC or Manufacturing. Participated in Change Control related Activities

JOB PREREQUISITES:

• Excellent computer skills with working knowledge of MS office, such as Access, Excel, Word, Trackwise, PowerPoint and Adobe Acrobat professional.
• Well-organized and detailed oriented professional, with strong verbal and written communication skills.
• Must be self-motivated with ability to handle, organize and prioritize multiple tasks and be able to perform under pressure to meet deadlines.
• Ability to meet attendance standards.
• All full-time employees are required to work a 40-hour week. Occasionally, it may be necessary to work additional hours in order to get the required tasks accomplished to meet deadlines.

PHYSICAL DEMANDS, MENTAL REQUIREMENTS, 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 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

Company Overview
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, 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.

EEO Statement
Akorn, Inc. is an Equal Opportunity Employer and takes pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.

This job has expired.