The Quality Associate is responsible for quality support and oversight of the final batch release and critical systems release process. Also, this role is responsible for identifying and implementing process improvements for the QA release department. Must be able to work a flexible work week, Tuesday through Saturday or Sunday through Thursday.
- Performs final review of batch and/or critical systems documentation and determines acceptability by using standard operating procedures. Ensures presence and acceptability of all required documentation prior to the release of the product and/or system.
- Support the day to day management of the batch release process.
- Reviews documentation such as protocols, CWRs, qualifications, etc as assigned. Compiles certificates of analysis as required.
- Enters data into JDEdwards. Generates reports from Trackwise 8.
- Support annual product quality reviews and quarterly FDA reports.
- Assist the facility in preparation for quality audits and participate in corporate audits and external inspections.
- Own and support nonconformance investigations specific to QA Release processes.
- Identifies opportunities for continuous improvement; leads projects and implements continuous improvement initiatives.
- Communicates proactively with internal and external partners and management.
- Maintains files such that documents are readily available and easily retrievable.
- Trains and mentors less-experienced quality department employees
- Assists department with monthly/quarterly Quality System data review metrics and reporting
- Cross-trains and learns different positions in QA, such as training, and QA Technician roles, to fill in during vacations, leaves, and all-hands-on-deck situations.
- Collaborates within and outside department on special projects, including moving various programs and paper-based to electronic formats
- Strong computer skills including Microsoft Word and intermediate Excel skills required
- Exposure to and hands-on experience with a variety of applications is strongly desired
- Knowledge of documentation systems and familiarity with batch/systems documentation and GDP preferred
- Must be detail-minded and exact in terms of working with documentation
- Strong drive to be an independent learner
- Ability to work with minimal supervision in a dynamic environment while following written procedures
- Must be organized and able to prioritize tasks
- Ability to communicate efficiently orally and in writing with all levels of the organization (especially with production supervisors, manufacturing associates and the engineering team) and with external clients
- Must be flexible, thick skinned and adaptable to shift gears gracefully through changing priorities.
- Cannot be allergic to Cephalosporin drugs
- Ability to think on your feet
- Resourceful with a good sense of humor
- Must be willing to work an alternate work week (ex: Tue-Sat or Sun-Thu) and able to work overtime as needed
- Embody the Takeda Leadership Behaviors: Be Positive. Be Accountable. Be Results-Driven. Be an Excellent Manager of Self and Others.
- High School diploma or equivalent required; AA/AS degree preferred; 2-5 years of experience, preferably in an FDA-regulated environment (pharmaceutical or food industries)
- Bachelor s degree preferred
- In general, the position requires a combination of sedentary work, standing work, and walking around observing conditions in the facility (light to medium work)
- Must be able to lift, push, pull and carry up to 30 lbs.
- General office environment
- Must be willing to adjust work hours and work overtime based on business needs.
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.