QA Batch Record Specialist
Akorn 2

Job Info

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The QA Batch Record Specialist reviews executed batch records and all associated documentation to ensure compliance with written Policies and procedures and completeness of documentation as required for batch release. This individual will work in a detail-oriented compliant manner to review records. This individual must be able to manage a work load of varying priorities while adhering to strict deadlines. The QA Batch Record Specialist can perform all tasks associated with QA Batch Record Reviewer with routinely demonstrated excellence.

• Perform first Quality review and release of executed batch records.
• Review and certify component release documentation and released Raw Material documentation for production use.
• Review QC Chemistry and Micro Certificates of Analysis for all applicable products manufactured.
• Review of specific in-process, and finished product test data.
• Document retrieval from local files and archives, as required for submissions and customer requests.
• Assist in process audits and internal audits as needed.
• Report Error Weekly Metrics (Right the First Time) found during review to Management
• Works closely with QA functional teams to align and promote awareness on data integrity and good documentation practices.
• Report of weekly/monthly/quarterly metrics (Right the First time, Error free and Success Rate) to Quality Management.
• Facilitate and Coordinate with Project teams to enhance, improve and streamline batch records cycle time
• Navigate through various online platforms, including JDE and Track Wise
• Facilitate and support online platforms implementation including Veeva and BMRAM
• Initiate product non-conformance investigations and deviation investigations in Track Wise as necessary.
• Assist in inter-departmental training and provide compliance guidance to personnel.
• Perform inter-departmental tasks as requested.
• Routine interaction with other departments for purposes of collecting batch record information or working to resolve documentation issues.

Qualifications

• Bachelor’s Degree (BS or BA) in a science related field (i.e. math, chemistry, biology) is required
• 5+ years demonstrated excellence in the pharmaceutical industry or in a laboratory setting
• Must have a complete knowledge of current Good Manufacturing Practices, United States Pharmacopeia, current Code of Federal Regulations (21 CFR parts 11, 210, 211, 820) and other FDA regulations and guidance’s.
• Strong verbal and written communication skills. Resourceful and well organized.
• Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists.
• Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
• Ability to follow safety and security practices.

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.

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