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Analytical QA Specialist I

Location: US - Vandalia, OH
Requisition Number: 1743

Description

ANALYTICAL QA SPECIALIST I

Adare is a global specialty pharmaceutical company inspired to improve the lives of patients whose treatment needs are not fully addressed by current medications. We use our unique combination of experience, proprietary capabilities, and resources to create meaningful products for them.

Our entrepreneurial and performance driven culture encourages us to take risks, identify promising ideas, and see those opportunities through to completion. Our collaborative spirit and dedication to developing strong partnerships provide Adare and our partners with significant advantages in competitive markets.

Adare is a high-growth company with a long history of success from concept through commercialization. Our ability to create differentiated drugs guides the identification and development of the novel products in our pipeline and our acquisition strategy.

THE OPPORTUNITY

The primary responsibility of this position is the auditing and approving of quality analytical documentation (test sheet, analytical notebooks, SOP, logs etc.) and ensuring adherence to cGMP’s.

SCOPE

The primary duties and responsibilities of this position include the following.  Other duties may be assigned.

  • Audit and approve executed commercial analytical testing records.
  • Review and approve Out of Specification (OOS) Investigations and results.
  • Review and approve Batch Production Records
  • Review and approve Non-Conformance Investigations (Raw Material, QC, SOP).
  • Maintain and assure correctness of quality documentation.
  • Interface with all departments within the company.
  • Release Finished Product for shipment.
  • Ensure facility adherence to cGMP and SOP.
  • Maintain the confidentiality of pertinent information.
  • Work as part of the Quality Assurance team to meet company, departmental, and individual goals as outlined by management.

CREDENTIALS

Bachelor’s Degree in a Physical/Life Science field preferred, with 0-2 years of Quality experience.

ATTRIBUTES & COMPETENCIES

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. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. 

  • Knowledge in cGMP as related to records and documentation in a bulk pharmaceutical and solid oral dosage manufacturing environment.
  • Understanding and/or working experience of laboratory processes and equipment.
  • Accuracy and neatness of compiling documents are required.
  • Good oral and written communication skills.
  • Microsoft Office proficiency.
  • Must be able to stand, walk, push, twist, reach overhead, and bend to the floor.
  • Must have visual sharpness for reading written instructions and computer screen.

Adare Pharmaceuticals, Inc. is an Equal Opportunity Employer - M/F/V/D

Adare does not accept or acknowledge 3rd party candidate submittals or hiring manager solicitations.  All staffing inquiries should be submitted to staffing@adarepharma.com .





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