Exciting new opportunity for an experienced Compliance Specialist who will work closely within the Manufacturing Compliance group to achieve department goals. The Compliance Specialist is also responsible for owning and driving manufacturing compliance improvement through deviation resolution, applied root cause analysis and the application of CAPA to elevate safety, quality, cost, on-time delivery, and right first-time performance. The Compliance Specialist supports by working cross-functionally with internal support departments to drive improvements to completion.
location: Cambridge, Massachusetts
job type: Contract
salary: $55.00 - 58.70 per hour
work hours: 9 to 5
education: Bachelors
responsibilities:
- Lead event investigations to adequately identify root cause and implement appropriate corrective and preventative actions to prevent reoccurrence,
- Lead CAPA investigations and at times manage the implementation of CAPA.
- Own manufacturing related change controls.
- Responsible for organizing data and preparing appropriate documentation, including presenting materials, for assigned projects.
- Recommending batch record and SOP improvements to reduce or eliminate GDP errors or correct root causes of deviations.
- Review production documentation and perform quality walk-throughs during manufacturing events
- Participate in continuous improvement teams such as 5s, Gemba and Production Systems (GPS).
- Provide training and guidance to team members on compliance-related matters to promote a culture of compliance throughout the organization.
- Lead team meetings and facilitate multidepartment discussions.
- Stay current with biopharmaceutical industry best practices and technologies.
- Other duties as assigned
qualifications:
- Bachelor's degree or equivalent experience.
- 3+ years of related experience.
- Demonstrated knowledge of cGMP manufacturing with knowledge in manufacturing operations in downstream processing utilizing single use technology (SUT).
- Experienced with standard troubleshooting approaches (problem statement, root cause analysis, Ishikawa (fishbone diagram), 5 Whys).
- Good computer skills, knowledge of Microsoft office products - Word, Excel, Office.
- Collaborate with cross-functional teams to integrate compliance measures into various aspects within manufacturing operations.
- Ability to work in a cleanroom environment and comply with hygiene standards and use of clean room gowning.
If you have the following characteristics, it would be a plus:
- SME or experienced with some or all of the following process equipment; homogenizers, tangential flow filtration (TFF), ultrafiltration/diafiltration (UFDF), Single use technology (SUT), buffer preparation and filtration.
- Experience with regulatory agency interactions and inspection discussions preferred but not required.
- Excellent verbal/written communication skills.
- Facilitation and demonstration skills
- Attention to detail and the ability to work individually and within multi-disciplinary teams
- More advanced knowledge / proficiency with business software (i.e. Excel, Visio) and industry systems (LIMS, ERP, SAP)
skills: SOP, MS-WORD, CAPA, MS-EXCEL, MS-Powerpoint, LIMS (Laboratory Information Management System
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 health, an incentive and recognition program, and 401K contribution (all benefits are based on eligibility).
Applications accepted on ongoing basis until filled.
