Support II/Tech III
Quality Documentation Coordinator II
Responsible for local/site ownership of the Quality Documentation System (Veeva) including Documentation System subject matter expertise, training of new users, refresher training of current users, creation/maintenance of performance metric(s), generation of Daily Issuance Report and coordination with the Training Department for daily issued/effective documents, and periodic review oversight.
Other key responsibilities include maintenance of Validation Documentation Vault and assembly of Validation Binders/Packages.
- SME of all aspects/roles within Veeva (e.g. document owner, QA approver, Technical Owner).
- General Documentation Responsibilities as per governing procedures.
- Training (and refresher training) of employees for the different levels of access within Veeva in both classroom setting and on 1-on-1 basis. This includes NEO training.
- Serve as SME for Documentation Control (Veeva) during audits/inspections (e.g. Regulatory Agencies, Internal/Corporate).
- Works closely with training department during coordination of issued/effective documents.
- Maintain and update departmental business indicators. Prepare metrics for the Quarterly Management Review. Identify trends, develop, and implement corrective actions.
- Data mine, compile, and analyze documentation data. Create new databases and queries as required. Generate and deliver meaningful, actionable documentation reports.
- Assist departments with document updates to meet periodic review deadlines.
- Represent Quality Documentation and/or Thousand Oaks on documentation system matters, teams, councils, and committees.
- Generate Saba reports (Certification Assignments and Status, Role Assignments and Status, general Saba knowledge).
- May need to assist Center-led (i.e. Global or Corporate ) organization and/or Lawrence Facility in Veeva/Documentation related projects/actions.
- Ability to accurately follow established procedures.
- Understanding of how documentation has the potential to affect product quality and safety.
- Provide customer service for document change requests, document history, copies, etc.
- Maintain paper and electronic files associated with Documentation. Archive records as needed per respective corporate SOPs.
- Seek and offer suggestions for continuous improvement. Benchmark best practices across the business network and corporation.
- Coach, train, advise and develop other Documentation Coordinators.
- May perform other duties as assigned.
Strong interpersonal skills are necessary. Must be a strong team player with effective, positive, and collaborative customer service skillset.
- Must be able to read, write, and converse in English.
- Must be able to work within a Quality Documentation System.
- Intermediate skill level with MS Office Software, primarily MS Word (but including Excel, Visio, PowerPoint, SharePoint)
- Must be detailed oriented (e.g. accurately enter data), have the ability to meet deadlines, and handle sensitive/confidential information on a regular basis.
- Solid analytical skills and sound judgment.
- Strong written and verbal communication skills. Able to present business indicators during respective meetings.
- Knowledge of cGMP manufacturing and Good Data and Documentation Practices.
- Must be able to read and follow detailed written instructions.
- Must be able to navigate, conduct searches, and complete online forms on personal computer for the purposes of training, performance management, and self-service applications. Must have the ability to navigate electronic mail systems and intranet for communication purposes
- Able to interface/interact with other departments.
- Good interpersonal skills and be able to work effectively and efficiently in a team environment.
- Must have the following personal attributes: integrity and trust, work ethic, sound judgment, intellectual honesty, pragmatism, courage and conviction.
- Must have passion to innovate and drive for solutions.
- Must display eagerness to learn and continuously improve.
- Must have uncompromising dedication to quality.
- Must have relentless focus on rapid and disciplined action.
- Must have respect for individuals and the diverse contributions of all.
- Must be able to multi-task and adapt well to change.
- Must be able to work independently to meet departmental/facility goals.
Education and/or Experience:
- High School Diploma.
- 0-2 years office professional experience
The overall physical exertion of this position is sedentary work. Although a sedentary job is defined as one that involves sitting, a certain amount of walking and standing is often necessary in carrying out job duties. Jobs are sedentary if walking and standing are required occasionally and other sedentary criteria are met.
- May be required to lift up to 25 pounds at a time and occasionally lifting or carrying articles like files or banker box of documents.
- May be required to stand and walk frequently to access other areas in the facility.
- May be required to kneel occasionally when filing.
- May be required to climb step stool occasionally when filing.
- May be required to reach overhead frequently when filing.
- May be required to climb stairs frequently during access to other in the facility. Elevator access provided to 2nd floor work area
- May be required to carry occasionally when filing or taking documents/supplies/laptop to other areas of the facility
- May be required movement of head/neck frequently when communicating with co-workers/customers, answering the phone, and filing.
- May be required to use repetitive motion frequently of hand, finger, and wrists for the purpose of typing, data entry, and manipulating computer mouse
- May be required to grip and grasp frequently when using a computer mouse
- May be required to drive rarely for trainings and meetings at Lawrence facility.
- May be required to use hearing frequently when communicating with personnel in person or on the phone
- Normal office environment
- Inside working conditions
- Work at computer monitor for the majority of the day
- Overtime may be required at times
- May be required to work or be assigned to a different shift as needed
- Must be able to work more than 8 hours a day or 40 hours a workweek as required
- May be required to travel for business reasons (e.g. training and meetings)
- Will have interaction with other people
- Pace may be fast and job completion demands may be high
Notice to Employment / Recruitment Agents:
Employment / Recruitment agents may only submit candidates for vacancies only if they have written authorization to do so from Shire, a wholly-owned subsidiary of Takeda s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire, a wholly-owned subsidiary of Takeda will only pay a fee for candidates submitted or presented where there is a fully executed contract in place between the Employment / Recruitment agents and Shire, a wholly-owned subsidiary of Takeda and only if the candidate is submitted via the Agency Portal. Candidates submitted or presented by Employment / Recruitment Agents without a fully executed contract or submitted through this site shall not be deemed to form part of any Engagement for which the Agency may claim remuneration.
Equal Employment Opportunity
Shire, a wholly-owned subsidiary of Takeda, is an Equal Opportunity Employer committed to a diverse workforce. Shire, a wholly-owned subsidiary of Takeda, will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, national origin, ancestry, age, sexual orientation, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law.
EEO is the Law - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf
EEO is the Law Supplement - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCP_EEO_Supplement_Final_JRF_QA_508c.pdf
Pay Transparency Policy - https://www.dol.gov/ofccp/pdf/pay-transp_formattedESQA508c.pdf
Shire, a wholly-owned subsidiary of Takeda, 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.