SUMMARY:

Compliance Specialist is responsible for working with the on-shift teams, QA lab and Document Specialists in reviewing SFOL comments to mitigate risks associated with batch report releases, heldware and resolving/communicating any compliance related issues. This role will be responsible for auditing and reporting compliance issues as well as assisting with Quality Lab tasks as needed.

Essential Jobs and Responsibilities include, but are not limited to, the following:

• Work within the numerous databases i.e. (QSI, Compliance Pro, Shop Floor on Line, JD Edwards Software, etc.) for research & resolution
• Communicating non-conformances & reporting issues to Leadership.
• Assess company operations to identify compliance risks.
• Audit processes & verify production compliance.
• Completing daily/weekly compliance audits and communicating as necessary to leadership.
• Assist Lab Technicians in daily tasks as needed.
• Work with supervisors, leads, process techs, and QA techs to make sure SFOL comments are accurate and timely. Review data and ensure the comments state a concise finding, root cause analysis, and resolution. Initiate heldware or audits where needed.
• Identify non-performances and report them immediately.
• Report daily findings.
• Must follow and comply with all ISO 9001, ISO 15378 established requirements
• Must follow and comply with Safety & Quality Absolutes
• Other duties as assigned.

Contribution to Safety, Quality and GMP

• Maintain a clean, healthy and safe workplace by ensuring adherence to safety standards.
• Conduct required safety reviews of equipment and processes prior to project start-up.
• Support the accomplishment of your work groups through the quality, timeliness and professionalism of your attitude.
• Supply accurate and timely data as required by performance tracking and reporting.
• Apply resources in a manner that maximizes their effectiveness while assuring quality.
• Maintain a work environment that will contribute to the assurance of safety and GMP compliance.
• Adhere to established procedures, perform self-checking and pay attention to detail in the performance of you and your team’s work.
• Notify management in a timely manner of any problems with procedural compliance.
• Report observed quality problems and deficiencies in a timely manner.
• Make recommendations to management for improving the quality and efficiency of your work.
• Oversee work to ensure projects are completed.

Competency and Expectations

• Safety Leadership – Embodies commitment for a safe workplace; acts as a role model.
• Accountability – holds self-accountable evidenced by say/do ratio, initiative and ownership actions such as ensuring safety is more important than productivity).
• Communication – ability to communicate safety, goals and company expectations with appropriate levels of the organization; create clear, timely audience appropriate messages (both written and verbal)
• Engagement – communicate and support the vision of plant leadership; celebrate the wins and ensure employees actively participate in safety-related activities.
• Team Development – understand the development needs of employees in your organization; drive the culture of employees as safety leaders; champion talent development from pre-hire to continuous learning.
• People Agility – understand personal strengths and weaknesses; leads by example; promotes change through listening skills and seeking frequent input from employees; is genuine and approachable; firm but fair – consistent.
• Problem Solving/Conflict Resolution – identifies and resolves problems in a timely manner; gathers and analyzes information skillfully; develops alternative solutions; mitigates relationship conflicts and encourages constructive (problem-solving) conflict.

• High School Diploma, GED or equivalent required. 
• Previous Quality Experience.
• Must possess excellent interpersonal, communication, written and leadership skills
• Capable of reading, writing, and speaking English.
• Capable of lifting up to 35lbs periodically.
• Capable of maintaining an attendance record within Company guidelines and working required overtime.
• Ability to solve practical problems; ability to interpret instructions in written, oral, diagram or schedule form.
• A working knowledge of multi-step manufacturing processes and Quality activities.
• The ability to read and understand Policies, Standard Operating Procedures (SOPs) and Work Instructions (WIs) including being proficient in Microsoft Office.
• Strong working knowledge of the terminology used within the manufacturing processes including working knowledge of the relationship between the departments and functions.
• Strong communication skills.