- Cambridge, MA
- $61.42 on w2
- 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 the *** 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
- 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 meet schedule is required; this position may infrequently include shift, weekend, or holiday work and overtime as dictated by a 365-day production schedule.
- Ability to work in a cleanroom environment and comply with hygiene standards and use of clean room gowning.
- This job is on-site M-F at Binney Street in Cambridge. There is limited ability to work from home.
- 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 is 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)
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Compliance Specialist - Cambridge, United States - eTeam
Description
Title:
Compliance Specialist - Level 2
Location:
Hybrid Remote
Pay Rate Range:
Candidate MUST have a MFG background
Shift = 1st shift hours (flexible with times)
Interview Process = zoom video interview for scheduling
Client is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organization where people can thrive.
Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years.
Client has an 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.Key Responsibilities:
Basic Qualifications:
We are looking for professionals with these required skills to achieve our goals:
Preferred Qualifications:
If you have the following characteristics, it would be a plus:
Client is a global biopharma company with a special purpose -to unite science, technology and talent to get ahead of disease together -so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns -as an organization where people can thrive.
Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years.
Our success absolutely depends on our people.While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making Client a place where people can thrive.
We want the Client to be a place where people feel inspired, encouraged and challenged to be the best they can be.
A place where they can be themselves -feeling welcome, valued and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.
