Aseptic Compliance Specialist VIII
2 weeks ago
expertise
in Autoinjector, Inhalation, Transdermal/Intradermal Patch Technologies. We partner with our customers to improve patient outcomes around the world. Together, as One Team, we will manufacture many more tomorrows.
Ready to work with purpose? Look no further, we are hiring for a motivated, talented, and passionate
Aseptic Compliance Specialist to join our St. Louis Missouri team
The Aseptic Compliance Specialist will provide guidance, coaching and coordination for all aspects related to the initiation, tracking, trending and management of all manufacturing investigations, corrective, and preventive actions (CAPA), evaluation of CAPA effectiveness and Operational Excellence (OpEx) projects within Sterile Product Manufacturing (SPM).
The position works with the Production Management and Quality Assurance to facilitate the consistent, disciplined execution of the quality management system ensuring the completeness and comprehension of the investigations and determination of most probable root cause.
The position will review and analyze corrective and preventive action effectiveness through appropriate tracking and trending methods in order to prevent reoccurrence.
ROLE RESPONSIBILITIES:
The essential functions of the position may include but are not limited to:
Facilitates adequate completion of manufacturing investigation efforts to ensure compliance with quality and cycle time standards.
Works closely, provides guidance, coaching and feedback to all groups who are involved in initiating, completing, and conducting manufacturing investigations and CAPA investigations.
Gathers and analyzes historical data to identify trends and root cause of manufacturing deviations. Recommends corrective and preventive actions to prevent/ eliminate recurrent discrepancies and leads its implementation in Operations. Measures CAPA effectiveness.Ensures that QAR System requirements are being executed as established in the site's SOP and corporate guidelines. Provides the necessary coaching and guidance to ensure practices are in compliance with guidelines.
Is the primary contact in the resolution of conflicts and differences resulting from the resolution of Manufacturing Investigation Reports (MIRs).
Collaborates in the design and deployment of training to educate employees on how to report, initiate, conduct and close an investigation.
Leads efforts to educate leaders and employees on OpEx methods, practices, and tools.Supports process improvement initiatives that increase quality/compliance, efficiency, and safety within the Sterile Product Manufacturing facility.
BASIC QUALIFICATIONS:
Bachelor's degree in science or Engineering with 3 or more years of experience in the pharmaceutical and medical device industry working with manufacturing investigations and/or regulatory issues.
Master's degree in science or Engineering with 3 or more years of experience in the pharmaceutical and medical device industry working with manufacturing investigations and/or regulatory issues.
Experience:
Minimum experience in a cGMP environment, as described above, with a strong working knowledge of a variety of quality systems and processes.
Must have demonstrated proficiency in organizational and project management skills and must be able to balance multiple priorities to meet established timelines.
Strong background in GMP Manufacturing, QA/QC, Aseptic Manufacturing, Medical Device, and/or Environmental Monitoring is highly desirable.Communication:
Excellent technical writing 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.
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. Ability to coach and provide guidance to others.
Computer literate, with superior skills in managing Excel spreadsheets (or similar database). Strong presentation skills.
Must be self-motivated and willing to learn new and changing responsibilities.
Candidate must demonstrate commitment to values-based leadership and achieving objectives in a manner that is supportive of Kindeva core values.
PHYSICAL/MENTAL REQUIREMENTS:
Must be able to walk, climb stairs, and don aseptic gowning items per applicable SOP.
Expected to train in aseptic gowning and spend extensive time in aseptic processing area with assigned equipment and systems.
Job duties involve occasional lifting (less than 35 lbs.), reaching, and sitting while working at computer terminal.
May occasionally require/entail weekend/evening work.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS:
This position requires regular onsite attendance – this position cannot be performed on a remote or telecommute basis on a temporary, short, or long-term basis.
Must have the ability to simultaneously multi-task across multiple capabilities and functions and handle multiple competing priorities and requirements, including performing site and functional responsibilities, responding to frequent e-mail and phone communications, and attending multiple meetings and conference calls.
Note that these activities may not be time bound to core hours or presence at the site.Must have the ability to work effectively under and manage to strict production, time, and performance deadlines.
Must be willing and able to work beyond the hours typically defined as a "regular" workday, which may or may not include weekends and holidays.
The capability to focus attention on the colleagues' behaviors that in turn leads to higher than normal performance.Ability to hold self and others accountable and to encourage colleagues to take personal responsibility for their performance / actions.
Ability to coach combined with a willingness to develop others and to share ideas.Expert at providing constructive feedback that leads to positive reinforcement.
Must be able to communicate and work well interdepartmentally, as well as, with all plant departments.
Must be able to read and write, as well as follow written and oral instructions.
Must be self-motivated, able to work independently and have a problem-solving mindset.
Promote a positive team environment.
Perform all tasks in a safe manner.
OTHER INFORMATION:
Successful candidate will be required to complete various levels of gowning certification to enter and support the manufacturing areas.
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