If you are interested in a quality career opportunity with a growing chemical manufacturer and a major global supplier of chemical ingredients to the bio-pharmaceutical industry, then this may be the job for you!
BioSpectra is seeking a Compliance Support person to expand the Compliance Team. This role will help ensure that procedures and requirements are followed and that quality is enforced at all BioSpectra USA facilities. This is an entry level quality position and an exciting career opportunity for someone who has recently graduated from college or university or plans on graduating soon.Â
 Major Roles & Responsibilities:
The ideal candidate will be able to perform the following essential responsibilities:
- Good Documentation Practices: Ensures that current good documentation practices for all compliance and regulatory documentation are observed and followed.
- Compliance Inspections:Â Completes a facility checklist to assess if procedures and requirements are being followed.
- Supplier, Manufacturer and Service Provider Qualification & Monitoring Support: Assists with the collection and compilation of data, as well as completes necessary documentation in support of BioSpectra’s Approved Supplier Program.Â
- Internal Audits & Effectiveness Assessment Support: Assists with the performance of internal audits, CAPAS, and effectiveness assessments to ensure BioSpectra’s programs are compliant and continuously improving.
- Compilation of Data and Assessments:Assists with the compilation of data and assessments related to:
- Commercial Requests to support Customer Requests for Documentation
- Compliance Department Change Controls
- Compliance Department generated documentation for Regulatory Dossiers
- Contamination Prevention Effectiveness Assessments
- External Reference Review Action Plans
- Preparation for Leadership Review
Qualifications:
The ideal candidate will be a recent graduate or will graduate soon with the following educational background:
- A two-year degree in science, math or related field with sufficient exposure to scientific, chemistry and statistical concepts and knowledge is required. A four-year degree is preferred.
In addition, the ideal candidate will have the following qualities, which will be critical to their success in this role.
- Effective Communication: Highly proficient level of written and verbal communication with a demonstrated ability to convey moderately complex information in a concise and understandable way.Â
- Organizational Aptitude: Ability to organize data and information in a logical way so that it is easily retrievable and interpreted.
- Critical Thinking:Â Ability to assess a situation and act decisively and effectively based on this assessment.
- Professional Demeanor: Ability to handle confidential and sensitive information in a professional manner that appropriately protects the confidentiality of the information.
- Software Technology: Strong ability to use software technology and systems.Â
If you believe you have the right background and qualities
and want to build a career with a growing global organization, please reach out to us!
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