Ready to transform complex manufacturing anomalies into flawless, inspection-ready narratives? As a Sr. Specialist, you'll dive into the heart of GMP operations-spearheading high-impact deviation investigations, mastering root cause analysis, and orchestrating cross-functional compliance excellence.
location: Norwood, Massachusetts
job type: Contract
salary: $60 - 70 per hour
work hours: 9 to 5
education: Bachelors
responsibilities:
- Author, review, and manage GMP manufacturing deviations, investigations, CAPAs, SOPs, and batch records using ALCOA+ principles.
- Lead root cause analyses utilizing fishbone, 5-Why methodologies, and risk assessments to ensure timely closure of quality records.
- Partner cross-functionally with QA, MS&T, Engineering, Validation, and Supply Chain to gather data and resolve process discrepancies.
- Provide on-the-floor support for manufacturing assessments, fact-finding, and troubleshooting quality events.
- Support audit readiness, track investigation metrics, and drive continuous improvement or training initiatives.
- Utilize electronic quality systems and manufacturing platforms including Veeva, SAP, Syncade, DeltaV, and LIMS.
qualifications:
Required:
- Bachelor's or Master's Degree in Engineering, Life Sciences, Pharmaceutical Sciences, Chemistry, Biology, Biotechnology, or related technical discipline.
- Typically 5-8 years of experience in pharmaceutical, biotechnology, or medical device manufacturing within a GMP-regulated environment.
- Typically 3-5 years of relevant GMP experience in deviation investigations, technical writing, manufacturing support, or quality systems.
- Experience authoring and managing deviations, CAPAs, change controls, and GMP technical documentation.
- Strong understanding of GMP regulations, GDP, ALCOA, and quality systems.
- Experience supporting aseptic processing, solid oral dose, biologics, or sterile drug product manufacturing preferred.
- Familiarity with electronic quality management systems (eQMS) such as Veeva, TrackWise, or similar platforms.
- Experience with root cause analysis methodologies and risk management tools.
- Demonstrated technical writing and editing proficiency.
skills: Biology, Chemistry, Laboratory Information Management Systems (LIMS), SOP Development, Good Manufacturing Practices (GMP), Corrective and Preventive Actions (CAPA), Good Documentation Practices (GDP)
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.
Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).
This posting is open for thirty (30) days.
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
