QA Associate job vacancy in Osmotica – Jobs in Georgia

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Job Details
Company Name : Osmotica
Company Location : Marietta, GA 30062
Job Position : QA Associate
Job Category : Jobs in Georgia

Job Description :

POSITION OVERVIEW

The QA Associate will be responsible for supporting Quality Assurance (QA) activities in compliance with FDA/DEA/State Regulations, cGMP, and company policies, procedures and specifications with responsibility for the quality of Contract Manufacturing Organization (CMO) and Contract Packaging Organization (CPO) production of drug products and dietary supplements. This will include the review and approval of documentation (batch manufacturing records and/or packaging records, deviations, complaints investigations, CAPA, etc.), change control, and continuous QA improvement. The QA Associate will need a robust understanding of the applicable regulations, standards, and industry guidance to ensure regulatory compliance. The QA Associate is expected to perform the above activities in partnership with other departments.

Hybrid role (2-3 days in the office in Alpharetta or Marietta, 2-3 days working remotely)

DUTIES AND RESPONSIBILITIES

  • Perform documentation reviews with a high attention to detail using working knowledge of quality concepts and internal procedures.
  • Track documentation reviews and communicate progress through status updates in meetings and emails
  • Initiate, write, drive/lead deviations and CAPAs to ensure that all quality issues are thoroughly addressed and documented.
  • Participate in Change Control activities and review.
  • Write and review standard operating procedure (SOPs) and other applicable operation related GMP documents.
  • Perform Periodic Reviews of SOPs.
  • Assist in tracking batch document data, including quality metrics and trending data
  • Perform trend analysis of quality data and compile into reports
  • Participate in Quality Review Meetings by collecting and/or presenting data and metrics
  • Work with electronic systems for management of quality events, such as MasterControl, Veeva, and Compliance Wire
  • Support the development, continuous improvement, and maintenance of the Quality System.
  • Guide, develop, and train other functional areas regarding QA subject matter.
  • Accomplish goals by completing related activities as assigned thoroughly and in a timely manner.
  • Maintain a safe and healthy work environment by following written standards and complying with regulatory requirements.
  • This position will interact with both internal and external customers to include members of senior management.
  • Other job duties as assigned.


EXPERIENCE AND QUALIFICATIONS

  • Bachelor’s Degree in Science or Engineering or relevant scientific discipline from an accredited college or university.
  • Minimum of three (3) years’ experience in pharmaceutical quality.
  • Strong knowledge of cGMPs (21 CFR 111, 211) and related FDA and International Conference on Harmonization (ICH) guidance documents.
  • Good written, verbal, and problem solving skills.

The physical demands described here, typical to that of an office environment, are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to see, talk and hear. The employee frequently is required to sit and use hands along with fingers, to handle or feel. The employee is occasionally required to stand, walk, reach with hands and arms, climb or balance, and stoop, kneel, crouch or crawl. The employee may frequently lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision.

The work environment, typical to an office environment, characteristics described here are representative of those encountered while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The noise level in the work environment is usually moderate. Some travel may be expected. Infrequent travel in support of business activities may be required.

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