QA Compliance Support Specialist

Quality Assurance Compliance Support Specialist

If you are attracted to a career opportunity with a growing chemical manufacturer and a major supplier of chemical ingredients to the bio-pharmaceutical industry, this may be the job for you!

Bio Spectra is seeking a QA Compliance Support person to ensure that good documentation practices are followed. This is an entry level position and a career opportunity for someone who has recently graduated from college or university or plans on graduating soon.

Major Roles & Responsibilities:

The ideal candidate will be able to perform the following responsibilities.

• Good Documentation Practices:
  Ensures that good documentation practices for all compliance and regulatory documentation are observed and followed.
• Compliance Inspections:
  Performs compliance inspections as the primary inspector and an emergency back-up for all other inspectors.
• Supplier Corrective & Preventative Action (CAPA) Support:
  Collects data and completes necessary documentation in support of Supplier CAPAs.
• Internal Audit & Effectiveness Assessment Support:
  Assists with the performance of internal audits and effectiveness assessments.
• Compilation of Data and Assessments:
  Assists with the compilation of data and assessments related to:
  • Compliance Department Change Controls
  • Contamination Prevention Effectiveness Assessment
  • Preparation for Leadership Review
  • External Reference Review Action Plans
  • Compliance Department generated documentation for Supplier, Manufacturer and Service Provider Records and Regulatory Dossiers.
• Supplier, Manufacturer and Service Provider Qualification & Monitoring Support:

Qualifications:

The ideal candidate will be a recent graduate or will graduate soon with the following education, background.

• A two-year degree in science, math or related field with sufficient exposure to scientific, chemistry and statistical concepts and knowledge is required. The ideal candidate will have a four-year degree in Science or other closely related field but will also consider other fields which require a high level of attention to details.

In addition, the ideal candidate will have the following qualities which will be critical to their success in this role.

• Detail Orientation:
  Demonstrated ability to investigate details with the objective of determining that a process is meeting regulatory standards and in compliance.
• Effective Communication:
  Demonstrated ability to write communication at a highly proficient level and effectively communicate moderately complex information in a concise and understandable way.
• Organizational Aptitude:
  Ability to organize data and information in a logical way so that it is easily retrievable.
• Critical Thinking:
  Ability to assess a situation and act decisively and effectively based on this assessment.
• Professional Demeanor:
  Ability to handle confidential and sensitive information is a professional manner that appropriately protects the confidentiality of the information.
• Software Technology:
  Ability to use software technology and systems, to assist the Compliance Department as needed.

If you believe you have the right background and qualities and want to build a career with a growing organization, please reach out to us!