Shire Quality Control Specialist II in Lexington, Massachusetts
- Support the writing of validations , transfers, calibrations, qualifications (incl. S&R and CC), DP site SME (local training, communication site/DP owner]; support investigations; support investigation/issues and MI&S documents at audits, drafts submission files and MoH responses
Essential Duties and Responsibilities:
Contribute to projects in the development, execution, and data analysis of assay validation, method transfers, laboratory equipment qualification, and method improvement studies in the QC laboratories. Support completion of all protocols and validations in a timely and appropriate manner.
Contribute to the evaluation of new methodologies and transfers to determine business need and applicability to the area. Perform evaluations/testing as related to improvements or project. Provide recommendations for or implement instrumentation upgrades or improvements to drive optimal performance.
Support the writing of technical memos, reports, protocols, studies and other appropriate documentation to support laboratory validations, investigations and/or objectives.
Frequent use and general knowledge of industry practices, techniques, and standards. Provide technical support to the QC Laboratories.
Support global standards/strategies in continuous improvements.
Comply with control of lab documentation. Review data with application of good documentation practices. Maintain data integrity and ensure compliance with company SOPs and specifications, FDA, QSR, and cGMP regulations.
Assure compliance with company procedures, quality and regulatory requirements, and regulatory guidance documents including QSR, cGMP, USP, CFR, and compendia literature. Support and implement laboratory systems and/or guidelines to meet compliance requirements.
Support regulatory and non-regulatory audits (e.g. Internal Quality Assessment, Corporate, FDA, etc).
Support regulatory submissions /change control requests in a timely manner when required.
Proactively an actively contribute to a team setting to increase efficiency, solve problems, generate cost savings, improve quality, and provide new product support.
Support technical presentations and/or training to QC Laboratories (including management) as needed.
Ensure personal training requirements are met and training records are current.
Stay current in the technical and compliance field regarding lab instruments and methods.
Perform Disposal of Hazardous Waste as required.
Must demonstrate good cross-functional collaboration skills.
Must be able to effectively communicate (both verbal and written) with peers and managers, internal and external contacts.
Basic project management, organizational, and time management skills are a must.
Ability to manage multiple activities concurrently and ensure they are completed in a timely manner.
Ability to prioritize and thrive in a fast-paced environment
Demonstrate good technical writing skills.
Able to write effective technical documents.
Proficient in use of electronic word processing, spreadsheet, project management, and presentation tools such as Microsoft Office (Word, Excel, Project, PowerPoint).
Biology, Protein Chemistry experience preferred.
Education and/or experience
- Bachelors and 2-5 years of experience in Biopharm industry; and GMP know-how.
Additional Specific Experience:
Excellent communication, interpersonal and organizational skills.
Ability to work well both independently and in a team environment.
Ability to prioritize work and multitask.
Conducts work in compliance with cGMPs, safety and regulatory requirements.
Must be able to lift, push, pull and carry up to (25) lbs.
In general, the position requires a combination of sedentary work and walking around observing laboratory activities.
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.
May work around chemicals such as alcohol, acids, and buffers in a laboratory setting.
May be required to work in a confined area.
Some cool/hot storage conditions.
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.
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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.
Takeda is an industry-leading, global pharmaceutical company with an unwavering dedication to putting patients at the center of everything we do. We live our values of Takeda-ism – Integrity, Fairness, Honesty, and Perseverance – and are united by our mission to strive towards Better Health and a Brighter Future for people worldwide through leading innovation in medicine. Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. At Takeda, you will make an impact on people’s lives – including your own.