Quality Assurance Documentation Specialist

6 days ago


Boulder, Colorado, United States CORDEN PHARMA BOULDER INC Full time

Corden Pharma Boulder Inc. is a leading contract development and manufacturing organization (CDMO) of active pharmaceutical ingredients (APIs), excipients, and pharmaceutical Drug Products (DP). Our services enable pharmaceutical and biotech companies to manufacture medicines with the ultimate goal of improving people's lives.

We offer flexible and specialized solutions across five technology platforms: Peptides, Lipids, & Carbohydrates; Injectables; Highly Potent & Oncology; and Small Molecules. We strive for excellence in supporting this network and are committed to providing the highest quality products for the well-being of patients.

Job Summary

This Quality Assurance Documentation Specialist role provides support that facilitates seamless execution of the overall objectives of the Quality Department. The ideal candidate will have knowledge of cGMPs and Corden Quality SOPs and Guidelines as they apply to documentation protocol and validation activities.

The successful candidate will be accountable for submission and/or timely renewal of applicable site regulatory agency permits, registrations, and certificates. Additionally, they will maintain Quality Department regulatory document master files in compliance with retention schedules and other applicable corporate and regulatory requirements.

Key Responsibilities
  • Provides support for the Director of QA & Control in a professional and timely manner; to include compiling and communication of KPIs, composition of departmental correspondence, distribution of departmental reports, and other duties and special projects as needed.
  • Accountable for submission and/or timely renewal of applicable site regulatory agency permits, registrations, and certificates.
  • Maintains Quality Department regulatory document master files in compliance with retention schedules and other applicable corporate and regulatory requirements.
  • Issues batch records and associated labels, by ensuring the copy is a replicate of the master production instructions for each intermediate and API.
  • Serves as the backup Administrator for the QA Documentation Specialist of the Quality Department records database (Tabfusion) and off-site records storage duties (Iron Mountain).
  • Provides administrative support to QA and QC for site methods and specifications revisions and updates, as well as related change control documentation.
  • Confers with chemists, engineers, and production and quality personnel regarding changes made to procedures, reports, and all other documentation.
Requirements

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required.

  • Knowledge of cGMPs and Corden Quality SOPs and Guidelines as they apply to documentation protocol and validation activities.
  • Knowledge of process protocols, batch record requirements, and deviation reporting adequacy.
  • Ability to apply attention to detail, regulatory requirements; and a practical, defendable, logical approach to problem solving.
  • Knowledge of documentation systems from an auditing technique standpoint.
Qualifications

High school diploma or General Education Degree (GED) and 2 years related experience in a Quality Assurance role; or equivalent combination of education and experience. An understanding of chemical concepts and cGMP Manufacturing preferred.

Salary range is between $60,000 - $80,000 per year based on skills and experience.



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