Job Description
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!
BioSpectra 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!