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Senior Compliance Specialist in Supply Chain Management
2 months ago
Essential Skills & Competencies:
- Comprehensive understanding of cGMP standards relevant to biologic drug manufacturing.
- In-depth knowledge of cGMP storage and warehousing practices.
- Experienced in utilizing deviation management platforms, particularly TrackWise.
- Skilled in quality document management systems, notably MasterControl.
- Strong proficiency in computer applications with a rapid learning curve.
- Exceptional verbal and written communication abilities for articulating intricate business processes.
- Capable of coordinating, facilitating, and organizing resources effectively.
- Adept at fostering strategic partnerships.
- Ability to perform efficiently under high-pressure situations to meet tight deadlines.
- Highly organized with the capacity to manage multiple tasks concurrently.
- Detail-oriented with a focus on accuracy.
- Proficient in MS Office Suite (Word, Excel, Outlook, PowerPoint) and knowledgeable about emerging technologies.
- Strong analytical and logical reasoning skills for problem-solving.
- Competent in creating and maintaining both business and technical documentation.
- Exemplary customer service skills and a positive demeanor.
Required Qualifications:
- Bachelor's Degree with a minimum of five (5) years of experience in the pharmaceutical sector or other regulated industries, ideally in a Quality Assurance or compliance capacity; OR
- Associate Degree with at least seven (7) years of relevant experience in the pharmaceutical field or similar regulated industries, preferably in Quality Assurance or compliance; OR
- High School Diploma or GED with nine (9) years of experience in the pharmaceutical industry or other regulated sectors, ideally in a Quality Assurance or compliance role.