New job QA Batch Record Specialist in New Jersey

QA Batch Record Specialist

Company : Akorn, Incorporated
Salary : Details not provided
Location : New Jersey

Full Description

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.

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.

Safety glasses, close-toed shoes and latex gloves are required in many areas within the facility


  • Bachelor’s Degree (BS or BA) in a science related field (i.e. math, chemistry, biology)
  • 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.
  • Have general math skills; adding, subtracting, multiplication, division and percentage calculation. Ability to calculate figures and amounts such as discounts, interest, commissions, and proportions.
  • Able to use personal computer and standard office equipment such as fax and copy machines, calculator, and printers. Aptitude to learn computer programs as needed (i.e. Word, Excel) in addition to other business applications.
  • Strong verbal and written communication skills. Resourceful and well organized.
  • Ability to read and interpret standard documents such as: procedure manuals, employee handbook, job related publications. Ability to write routine reports and correspondence.
  • 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.

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, PC use and evaluation of test specimens.
Mental Requirements include:
  • Ability to write, read and apply technical scientific writing, procedures and quality policies
  • Ability to work independently in an efficient and detail-oriented manner.
  • Ability to work on multiple projects and priorities in a concurrent manner.
  • Ability to work in an independent manner, as well as a group environment
  • Ability to apply deductive reasoning and analytical thought to 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 a high level of office stress.
  • Ability to maintain confidentiality of work assignments and personnel issues

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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