Shire Compliance Investigator II in Lawrence Manufacturing Facility, California

Summary

The incumbent is a member of the manufacturing support team within the Los Angeles/Lawrence Manufacturing Facility site operations supporting change controls, CAPAs, document changes, training coordination, and audits. The incumbent will perform duties below under the supervision of manufacturing supervisor with minimal supervision.

In change control area, the incumbent is responsible for preparing change control documents and coordinating change control activities from initiation to completion/implementation as defined per the change control requirements. In the assigned shift, the incumbent will be the main change control initiator for manufacturing.

In CAPA area, the incumbent will perform root cause investigations for all Quality Events requiring Corrective and Preventive Actions (CAPAs). The incumbent will also work on all levels of CAPAs and be responsible from initiation to closure of all investigations in LMF.

In document life cycle management area, the incumbent will be responsible from initiation to closure of all document changes in LMF.

In training area, the incumbent will work with LA training team to ensure employees training records are entered into the system on a timely manner and all manufacturing team is assigned the correct modules/curriculums when changes to procedures/systems occur.

In audit area, the incumbent will interact with the inspection team and be responsible for any assigned audit responses.

In all above mentioned areas, the incumbent will perform status update of changes in systems utilized for change control, CAPAs, document changes, training, and audit.

The incumbent will work together with manufacturing team members as well as other support group members from quality, maintenance, engineering and technical services in a collaborative team environment.

Direct interactions with contractors, vendors, suppliers and customers may also be necessary.

Essential Duties and Responsibilities

  • Create change control documents (RTO, insignificant and significant PR’s) for manufacturing and maintenance PM’s as well as corrective maintenance.

  • Manage content and closure of RTO’s, significant and insignificant changes.

  • Coordinate activities as required within the change control documents.

  • Assign actions/tasks to manufacturing and other support functions.

  • Manage performance of change control as measured by the key performance indicators (KPI).

  • Interface with Trackwise 8 CCMS, LIMS and JDE for coordination of change control documents and status updates.

  • Attend meetings such as change control review boards, investigation meetings, QIT’s, planning meetings, project meetings, etc. representing manufacturing support team.

  • Create technical reports by compiling technical information as defined by the change control requirements

  • Present change control related information to change control review boards or auditors as necessary.

  • Perform documentation changes (SOP’s, batch records, PM’s, BOM’s, product specifications, etc.) or create new documents.

  • Manage and coordinate document changes for approval and implementation.

  • Assist manufacturing Subject Matter Experts (SME) in gathering information to execute process and document related changes within Quality change control management system.

  • Responsible for ownership of manufacturing procedures, forms, and specifications which includes revision, periodic review, and authoring of new procedures related to manufacturing

  • Support CAPA management process as a potential corrective action owner as applicable.

  • Responsible for conducting and documenting detailed investigations and recommending CAPAs that will minimize the number of exceptions occurring in manufacturing operations.

  • Utilize advance problem solving and root cause analysis tools to identify and resolve complex problems with minimal supervision.

  • Lead and/or facilitate Kaizens and problem solving events.

  • Collaborate with cross-functional teams to help determine root causes, resolves complex problems, and help identify appropriate corrective and preventive actions.

  • Write and manage events (CAPA investigations, UIs, ICARs, OOXs, containment and corrective actions) with minimal supervision and contribute to audit responses.

  • Represent manufacturing support department during the product release process, compliance, and continuous improvement projects and audits.

  • Facilitate investigation meeting and drive action items leading to timely closure of high risk CAPA investigations that could disrupt release of product.

  • Ensure timely release of product by working closely with QA release. Assist in meeting release time goals.

  • Be accountable for the effectiveness of corrective actions to ensure appropriate root causes have been addressed.

  • Participate in exception related meetings and provide feedback, leadership, and support to manufacturing supervisors, trainers, and manufacturing technicians on the status of compliance of the department.

  • Work with inspection readiness team teams, participate in audits, and complete investigations for audit responses.

  • Emphasize training programs designed to enable staff to consistently execute all manufacturing processes with strict compliance to cGMPs and EHS regulations

  • Work closely with LA training team to ensure employees training records are entered into the system on a timely manner and all manufacturing team is assigned the correct modules/curriculums when changes to procedures/systems occur.

  • Understands and analyzes business processes and functions in order to identify opportunities for continuous improvement.

  • Monitor the progress of continuous improvement projects and act as a liaison between the project manager, project team, and line management.

  • Work closely, and provide guidance where needed, to external and internal resources that directly impact manufacturing operations.

  • Manage all metrics related to change control, investigations, document changes, training, etc.

  • Interface with Quality organization partners to achieve quality and compliance objectives and goals.

  • Perform other duties as assigned.

Qualifications

  • Excellent technical writing and verbal communication skills in English.

  • Demonstrated interpersonal skills with the ability to interface and influence with personnel of all levels and participate effectively and efficiently in a team environment.

  • In-depth process knowledge of related manufacturing equipment and processes.

  • Excellent understanding of cGMP and all other country specific regulations as applicable to medical/biotechnology industry.

  • Must be able to read and follow detailed written instructions.

  • Excellent math and computer skills (Microsoft Office programs such as Powerpoint, Excel, Word, Project, etc).

  • Experience in JDE, automation, Trackwise 8, LIMS, Veeva or similar systems.

  • Ability to analyze and interpret scientific and statistical data.

  • Good problem solving and analytical skills

  • Excellent ability to lead investigations and provide comprehensive investigation write up.

  • Excellent presentation skills

  • Working knowledge of Quality systems.

  • Must be able to complete tasks with minimal supervision, prioritize multiple tasks, and manage time effectively.

  • Detail oriented and effectively organize documentation for review.

  • Must be able to independently recommend and suggest solutions.

  • Good interpersonal skills to work effectively and efficiently in a team environment.

Education and/or experience

BS/BA in Engineering or Scientific discipline, or in a related field with 2+ years minimum experience. Technical writing experience preferred. MS degree with 1+ years of relative experience or PhD with 0 years of experience.

Physical Demands

Must be able to lift, push, pull and carry up to 25 lbs.

In general, the work requires a substantial amount of sedentary work that includes typing and computer interactions with some walking around observing conditions in the facility.

Working Environment

Must be able to work in controlled environments requiring special gowning. Will be required to follow gowning requirements and wear protective clothing over the head, face, hands, feet and body.

No make-up, jewelry, contact lenses, nail polish or artificial fingernails may be worn in the manufacturing environment.

Must be able to work in a clean room and cool/hot storage conditions.

May be required to work in a confined area.

Must be able to work multiple shifts, including weekends.

May be required to work or be assigned to a different shift as needed.

Must be able to work overtime as required.

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Reasonable Accommodations

Shire is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please call 484-595-8400 and let us know the nature of your request and your contact information.

Shire is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We strive to develop best-in-class products, many of which are available in more than 100 countries, across core therapeutic areas including Hematology, Immunology, Neuroscience, Ophthalmics, Lysosomal Storage Disorders, Gastrointestinal/Internal Medicine/Endocrine and Hereditary Angioedema; and a growing franchise in Oncology.

Our employees come to work every day with a shared mission: to develop and deliver breakthrough therapies for the hundreds of millions of people in the world affected by rare diseases and other high-need conditions, and who lack effective therapies to live their lives to the fullest.