Senior Quality Assurance Compliance Specialist
2 weeks ago
Join Lonza, a global leader in life sciences, and become part of a dedicated team that upholds the highest standards in quality assurance We are seeking a Senior Quality Assurance Compliance Specialist to play a vital role in ensuring compliance and excellence in our operations. Your expertise will help us navigate regulatory standards and execute innovative processes effectively.
This position involves a unique shift schedule: Wednesday to Saturday, 9 PM to 7:30 AM.
Key Responsibilities:
- Conduct daily rotations through GMP operational areas to review documentation and observe work habits.
- Authorize the placement and removal of Quality Tag Outs.
- Provide support for GMP operations through the QA Hotline.
- Mentor teams in Manufacturing, QC, Engineering/Facilities, and MSAT on GMP practices.
- Document QAOTF shift notes thoroughly and ensure effective follow-up across shifts.
- Represent the QA department in meetings and project teams.
- Identify and implement best practices to enhance QA processes.
Key Requirements:
- Exceptional written and verbal communication skills.
- Strong attention to detail and excellent problem-solving abilities.
- Proven ability to communicate difficult information effectively and achieve positive results.
- Ability to facilitate constructive interactions across diverse teams, clearly conveying needs and listening attentively.
- Familiarity with SAP, TrackWise, DMS, and LIMS systems is a plus.
- Adaptability to shifting tasks while maintaining high efficiency.
- Ability to keep project leads updated on work status.
- A proactive and collaborative approach to driving projects to completion.
- Proficiency in Microsoft Office applications.
- Effective negotiation skills for resolving differing perspectives.
- Strong organizational skills to prioritize tasks efficiently.
Education:
- Minimum of a Bachelor's Degree.
- 3-5 years of relevant experience in quality assurance or a related field.
Every day at Lonza, our products and services positively affect millions of lives. We take pride in achieving our goals ethically, respecting our people and the environment. We invite passionate individuals eager to solve complex problems in life sciences to join us and experience the fulfillment that comes from making a meaningful difference.
We are an equal opportunity employer, welcoming all qualified applicants regardless of race, religion, color, national origin, sex, sexual orientation, gender identity, age, disability status, veteran status, or any other characteristic protected by law.
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