Shire QC Specialist III in Milford, Massachusetts
As a key member of the Quality Control team, the QC Specialist III is responsible to perform QC related technical writing associated with QC activities, investigations, CCRs, and CAPAs to ensure compliance based on regulatory and industry standards. The role will include performing site System Administrator rights for all QC electronic systems.
Essential Duties and Responsibilities
Write, review & revise SOPs reports, protocols & other appropriate documentation for proper functioning of lab operations.
Independently conduct and document laboratory investigations and CAPA implementations.
Work on special projects / protocol testing that involves new methods and instrumentation.
Serve as mentor to other Quality Laboratory positions as needed. Provide training and work direction for group members as required.
Assist in implementing quality & regulatory requirements (e.g., FDA, GLP, cGMP, USP, Ph. Eur., & CFR rules/guidelines).
Drive and participate in continuous improvement initiatives that impact production, increase efficiency, solve problems, generate cost savings, improve quality & provide new product support.
Perform review of test data, which includes overall documentation practices. Review data in LIMS.
Review validations for laboratory instruments and methods.
System administrator for QC equipment/instruments and systems.
Participate in internal laboratory audits as required.
Technical writing as needed
Strong leadership, organizational and time management skills. Clear ability to organize and prioritize work schedule in order to meet deadlines.
Must be able to communicate effectively with managers and peers. Must possess ability to foresee and communicate bottlenecks that impede completion of tasks in a timely manner.
Must demonstrate effectiveness in ability to train others as needed.
Strong knowledge and expertise of quality/regulatory requirements pertinent to pharmaceutical QC labs.
Strong working knowledge of laboratory safety including standard precautions associated with hazardous & biohazardous material handling.
Experience with electronic QC systems and software, as well as general knowledge/understanding of 21 CFR part 11 is required. Laboratory testing experience is highly desirable.
Computers skills to include full competence with Microsoft Word, Power Point & Excel and LIMS is required.
Education and/or Experience
Bachelor’s Degree in a biological science with minimum of 5 years of related experience (or Master’s Degree in a biological science with 1-4 years of experience) in a CGMP environment.
Frequent lifting up to 10 lbs; frequent standing/walking.
Manual and visual dexterity required to perform laboratory and computer tasks for prolonged periods.
Laboratory environment working with chemical reagents and analytical equipment
Normal office working conditions: computer, phone, files, fax, copier.
Personal Protective Equipment must be worn as required
Minimum travel required (occasional international travel to support CMO investigations).
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’s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire 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 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 is an Equal Opportunity Employer committed to a diverse workforce. Shire 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 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.