Senior Manufacturing Compliance Engineer

ROLE SUMMARY

The Senior Manufacturing Compliance Engineerposition 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.