New

Quality Systems Specialist (Biotech, Pharma/Manufacturing exp)

YOH Services LLC
United States, Massachusetts, Cambridge
Jan 30, 2025
Quality Systems Specialist (Biotech, Pharma/Manufacturing exp) Category: Life Science Employment Type: Contract Reference: BH-381844 Job ID: 2025-8862 Quality Systems Specialist (Biotech, Pharmaceutical and/or Manufacturing exp.) Cambridge, MA Remote (Local candidates will be considered first, huge plus to do onsite visits when necessary) 1 year contract (perm potential, but not guaranteed) Hours: 8AM - 4:30 PM EST (manager is open to an 8:30 AM start) Pay rate: $50 - $55 (depending on experience) *The successful candidate will be handling change control including weekly forum of updates of change control, serve as right-hand person for analysis, and have some level of experience with tech writing of SOPs. Regulatory intelligence will be a big part of this position including managing regulatory intelligence alerts, analyzing them, determine if there would be impacts and send out to the owner (manage and organize alerts) Top Skills: 2 + years of Veeva experience required along with Quality Management Systems Strong fluency in Excel (pivot tables & graph functions) Technical writing SOPs Position Overview:* The Specialist of Global Quality Systems will serve as the Process enabler and support for critical quality processes including Deviations, Corrective and Preventive Actions (CAPA), Change Control, Regulatory Intelligence, and Training within a global biotechnology environment . This role is essential in maintaining quality excellence and regulatory compliance across the enterprise while ensuring processes remain efficient and fit for purpose. Required Experience & Skills: Bachelor's degree in Life Sciences, Engineering, or related field 2+ years of experience in Quality Systems within biotechnology or pharmaceutical industries 1+ years of experience in manufacturing, operations, or related business areas Demonstrated experience in process ownership and quality systems management Strong understanding of GMP, GLP, GCP regulations and ICH guidelines Experience with electronic quality management systems (Veeva) Preferred Qualifications: Master's degree in related field ASQ certification (CQA, CQM) Experience with Lean Six Sigma methodologies International work experience Experience with change management and organizational development Key Responsibilities: Process Support Serve as global process support for Deviation, CAPA, Change Control, Reg Intel, and Training processes Facilitate analysis of Quality Systems metrics and performance periodically Manage Quality Systems deviations and CAPAs, ensuring proper investigation, resolution, and preventive measures Oversee Regulatory Intelligence assessments and maintain associated documentation Facilitate the Change Control Review Board and maintain associated documentation Partner with subject matter experts and business representatives to identify GxP training content needs and GXP curricula modification Support development of Quality related training content Support quality systems audits and regulatory inspections Provide guidance and support to site quality teams in process implementation Key Competencies - Strong process thinking and analytical skills - Strong experience in Excel - Excellence in project management and organization - Outstanding communication and presentation abilities - Proven ability to influence without direct authority - Strong facilitation and training skills Estimated Min Rate: $36.05 Estimated Max Rate: $51.50 Note: Any pay ranges displayed are estimations. Actual pay is determined by an applicant's experience, technical expertise, and other qualifications as listed in the job description. All qualified applicants are welcome to apply. Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran. Visit https://www.yoh.com/applicants-with-disabilities to contact us if you are an individual with a disability and require accommodation in the application process. For California applicants, qualified applicants with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act. All of the material job duties described in this posting are job duties for which a criminal history may have a direct, adverse, and negative relationship potentially resulting in the withdrawal of a conditional offer of employment.