REPORTS TO: Global GM - Quality Management & Compliance
PRINCIPAL PURPOSE OF JOB: Join our dynamic team as a Quality Assurance Consultant and play a pivotal role in elevating the quality standards for both GCI-SC and GTI-SC at our Orangeburg plant site. You'll spearhead the development and maintenance of all aspects of Quality Assurance, ensuring our commitment to excellence remains unmatched.
LEVEL OF AUTHORITY: Exercise your expertise with minimal supervision, empowered to make independent judgments within established guidelines and policies.
WORK ENVIRONMENT: Embrace a diverse work environment where the majority of your time will be spent indoors in a modern office setting. Get hands-on experience within our plant and lab facilities, balancing the best of both worlds.
ESSENTIAL JOB FUNCTIONS
- Champion compliance with cGMP and internal policies, procedures, and specifications, upholding the highest quality standards.
- Conduct thorough inspections, batch record reviews, and quality system functions in alignment with cGMP and related company SOPs, as well as state, federal, and local laws.
- Facilitate the seamless flow of controlled documents, managing Document Control numbers, logbooks, change requests, and document status reports with precision.
- Lead new hire training sessions on cGMP utilizing the latest ICH 7Q guidelines, ensuring a robust and up-to-date training program.
- Oversee periodic reviews of standard operating procedures, guaranteeing relevance and accuracy to meet evolving company policies and procedures.
- Maintain meticulous version control and issuance of all documents, ensuring accuracy and compliance at every stage.
- Drive maintenance and closure activities for critical documents such as reports, CAPAs, change controls, and complaints, fostering a culture of continuous improvement.
- Record and investigate deviations (Internal TAMEs) promptly, implementing corrective actions to maintain operational excellence.
- Ensure the calibration of Lab/Production equipment as per the Calibration planner, safeguarding precision and accuracy in our processes.
- Uphold Good Documentation Practices (GDP) underlying ALCOA principles (Attributable, Legible, Contemporaneous, Original & Accurate) to ensure the integrity of lab records.
- Guarantee the completeness and retrievability of manufacturing and lab records, facilitating smooth operations and compliance.
QUALIFICATIONS
- Bring your expertise in cGMP requirements, FDA regulations, and ICH 7Q guidelines to the table.
- Hold a Bachelor’s degree in a scientific discipline, demonstrating your commitment to excellence.
- Prior experience (at least 7 years) in Quality/cGMP within the API/Pharma industry is highly desirable.
- Proven track record in supporting regulatory/customer audits and implementing effective remedial measures.
- Previous Quality Assurance experience is essential, showcasing your ability to drive quality initiatives.
- Experience in a chemical plant environment is preferred, providing valuable insights into our industry.
- Cultivate strong interpersonal and communication skills, essential for collaboration and effective stakeholder engagement.
Job Type: Contract
Pay: $22.48 - $25.16 per hour
Expected hours: 24 per week
Experience level:
Schedule:
Education:
Experience:
- Quality assurance: 7 years (Required)
Ability to Relocate:
- Orangeburg, SC 29115: Relocate before starting work (Required)
Work Location: In person