Compliance Associate I

Employment Type

: Full-Time

Industry

: Miscellaneous



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Job Details

Description

Purpose and Scope

The QA Compliance Associate I is responsible for providing the Quality Assurance review of manufacturing batch records in support of product release to ensure compliance in accordance with company Standard Operating Procedures (SOPs), policies and current Good Manufacturing Practices (cGMPs), FDA and global laws and regulations.

Essential Duties & Responsibilities

  • Perform batch record compilation, review and maintenance. 
  • Perform detailed quality assurance review on executed batch records for commercial and development products.
  • Make entries into databases and spreadsheets that support the production schedule and quality indicators.
  • Perform investigation searches on executed batch records to ensure that deviations that apply to the batch record are known and can be assessed for closure by QA Management.
  • Work with various departments to request needed records and correct batch record errors.
  • Compile reviewed batch records into final complete executed batch record to make ready for final QA review for release of the product.
  • Manage released batch records and forward for document scanning.
  • Prioritize workload and coordinate activities to meet and support timely product release and ship schedules.
  • Perform other duties as assigned.
  • Knowledge, Skills & Abilities

  • Knowledge of cGMPs and other documentation and regulatory requirements.
  • Skill in organization and attention to detail.
  • Skill in effective written and oral communication.
  • Excellent troubleshooting and problem solving skills.
  • Knowledge of computer operations, including proficiency with MS Word, Excel and Access.
  • Ability to work independently
  • Ability to work well with employees at all levels and departments.
  • Core Values

  • The QA Compliance Associate I is expected to operate within the framework of Tolmar’s Core Values:
  • Consistently operate with the highest standards of ethics and compliance.
  • Take ownership of your actions, success and setbacks.
  • Respect each other and understand that honest collaboration is at the heart of our company success.
  • Go the extra mile to make things happen.
  • Be committed to all we do and the patients we serve.
  • Embrace change with enthusiasm.
  • Strive to learn about and understand the needs of customers and patients, and take action with great speed and efficiency no matter the task.
  • Education & Experience

  • High School diploma or equivalent required.
  • Associates degree in technical subject preferred. Some college work in technical subjects helpful.
  • Three or more years of experience in the pharmaceutical or medical device industry in a Quality Assurance role.
  • Working Conditions

  • Conditions are normal for an office environment. 
  • Qualifications

    Skills

    Behaviors

    :

    Motivations

    :

    Education

    Required

    High School or better.

    Experience

    Licenses & Certifications


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