Senior Manufacturing Compliance Engineer
2 weeks ago
Senior Manufacturing Compliance Engineer
19901 Nordhoff St, Northridge, CA 91324, USA
Job Description
Posted Friday, April 5, 2024 at 4:00 AM
ROLE SUMMARY
The
Senior Manufacturing Compliance Engineer
position is recognized as an expert internally in the principles and application of quality assurance. This role offers a unique opportunity to contribute your expertise and play a critical role in ensuring safety, efficacy, purity, and quality of manufactured products through compliance with cGMPs, regulations, and established procedures. This position will support inspection readiness and will collaborate with business owners to ensure compliance through periodic review of process, procedures, and policies.
ROLE RESPONSIBILITIES
The essential functions of the position may include but are not limited to:
Ensuring manufacturing operations and quality procedures for the area(s) are compliant to 21 CFR Part 210 and 211 requirements.
Conduct scientific, defensible investigations for any OOS, CAPA, or
QIR excursion.
Conduct and document Investigation promptly to support the
on-time closure of non-conformances to meet product fulfillment
dates.
Prepare root-cause and trend analysis to management during routine operation mechanisms (e.g. Management Review and CAPA Review Board).
Assists and supports the manufacturing staff in detecting and solving compliance errors in real time.
Assists in reviewing, editing, and authoring of SOPs / Master Batch Records and other technical documents.
Participate in continuous improvements of department processes.
Participate in inspection readiness and support activities
Participate in internal audit activities and help drive the closure of any observations.
Participate in process improvement initiatives (as necessary).
Tracking, trending, and reporting of compliance key performance indicators (training/QIRs) to Management.
BASIC QUALIFICATIONS
Education:
•
Bachelor's degree in a Science, Engineering or Other related technical field and 5+ years of related experience.
Communication:
• Excellent written and verbal communication skills with the ability to share vision, direction, and data with colleagues across all levels and in a wide range of different work groups including senior leadership and regulatory agencies.Proficient in word, excel, and Microsoft applications.
Success in Role:
• Strong analytical and problem-solving abilities.
• Tactful, persuasive, and assertive human relations skills.
• Effective leader, capable of making decisions using experience along with site process and procedures.
• Robust interpersonal skills and the ability to handle multiple projects.
• Self-motivated and adaptable, with a willingness to learn and adapt to changing responsibilities and priorities.
• Demonstrated commitment to values-based leadership and achieving objectives in alignment with Kindeva Drug Delivery values and behaviors.
Safety for our employees and our communities is a key priority for Kindeva Drug Delivery. Kindeva encourages everyone who can get vaccinated to get vaccinated.
Our Covid-19 task force monitors the external environment and will continue to evaluate our policies and procedures.
Equal Opportunity Employer:
Kindeva Drug Delivery is an Equal Opportunity/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, Protected Veteran status, sexual orientation, or any other characteristic protected by federal, state or local law.
19901 Nordhoff St, Northridge, CA 91324, USA
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