- Lead event investigations to adequately identify root causes 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
- 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, and knowledge of Microsoft Office products Word, Excel, Office.
- Collaborate with cross-functional teams to integrate compliance measures into various aspects of manufacturing operations.
- Ability to work in a clean room environment and comply with hygiene standards and use of cleanroom 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)
-
Compliance Specialist I
4 days ago
LexisNexis Risk Solutions Cambridge, United States**Essential Job Functions**:This job description indicates the general level and nature of work expected of the incumbent. It is not a comprehensive list of specific duties or activities associated with the position. The incumbent may be asked to perform other duties as assigned. ...
-
Compliance Specialist
1 week ago
Randstad North America, Inc. Cambridge, United StatesExciting 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 complian Compliance Specialist, Compli ...
-
Compliance Specialist
1 week ago
eTeam Cambridge, United StatesTitle: Compliance Specialist - Level 2 · Location:- Cambridge, MA · Duration - 12 months, but we are looking to make it full-time if the contractor performs well** · Hybrid Remote · Pay Rate Range:- $61.42 on w2 · ***Candidate MUST have a MFG background*** · Shift = 1st shi ...
-
Compliance Specialist
2 days ago
LanceSoft Cambridge, United StatesRole: Compliance Specialist - Level 2 · Location: Cambridge, MA, 02142 · Duration: It is a contract for 12 months (but we are looking to make it full time if the contractor performs well.) · On Site Position · Shift: 1st shift hours (flexible with times) · Description:Will wo ...
-
Compliance Specialist
4 days ago
Randstad USA Cambridge, United States Freelance, Full timejob summary: · 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 ...
-
compliance specialist
2 weeks ago
Randstad Cambridge, United Statescompliance specialist - level 2 us- first shift. · + cambridge , massachusetts · + posted today · **job details** · summary · + $55 - $58.70 per hour · + contract · + bachelor degree · + category life, physical, and social science occupations · + reference48012 · job details · jo ...
-
compliance specialist
2 weeks ago
Randstad Cambridge, United Statescompliance specialist - level 2 us- first shift. · + cambridge , massachusetts · + posted 2 days ago · **job details** · summary · + $55 - $58.70 per hour · + contract · + bachelor degree · + category life, physical, and social science occupations · + reference48012 · job details ...
-
compliance specialist
2 weeks ago
Randstad Cambridge, United Statescompliance specialist - level 2 us- first shift. · + cambridge , massachusetts · + posted 1 day ago · **job details** · summary · + $55 - $58.70 per hour · + contract · + bachelor degree · + category life, physical, and social science occupations · + reference48012 · job details ...
-
Operations Compliance Specialist
1 week ago
The RMR Group Newton, United StatesOverview: · The Operations Compliance Specialist ensures the accuracy and compliance of all Service Contracts/Service Orders, Construction Contracts, Certificates of Insurance as well as the Building Engines - CMMS (Work Order) System control. The Operations Compliance Specialist ...
-
Manufacturing Compliance Specialist
6 days ago
The Accuro Group Cambridge, United StatesBusiness Title: | Manufacturing Compliance Specialist Location: Cambridge, MA 02142 Job Type: Contract (12 Months) Note: Parking will not be reimbursed by the CLIENT. Parking is roughly $420/mo. Important: MFG background is mandatory. Job Description: THE CLIENT is a global bioph ...
-
Compliance Specialist I
1 week ago
LexisNexis Risk Solutions Cambridge, United StatesAbout the Business · LexisNexis Risk Solutions is the essential partner in the assessment of risk. Within our Business Services vertical, we offer a multitude of solutions focused on helping businesses of all sizes drive higher revenue growth, maximize operational efficiencies, a ...
-
RZ Compliance and Process Specialist
1 week ago
Nebula Ventures Mendon, United StatesAre you known for your collaborative work style, enjoy a wide variety of tasks, and take responsibility with enthusiasm? · Then FI-TS is the right place for you. · As one of the largest IT outsourcing partners in the financial and insurance industry, FI-TS serves leading banks, i ...
-
Sr. Drug Safety Specialist, Compliance
1 week ago
Proclinical Cambridge, United States ContractSenior Drug Safety Specialist, Compliance - Contract - Cambridge, MAProclinical is on the lookout for a dedicated and experienced professional to fill the role of Drug Safety and Pharmacovigilance Compliance Specialist. This is a contract position located in Cambridge, MA. · Prim ...
-
Partners Healthcare System Somerville, United StatesCome join our team and play a pivotal role in promoting and ensuring an environment where human subject research is conducted according to the highest standards · Our Team · Our Human Research Affairs Compliance and Education Office was established in June 1999 as the Quality Ass ...
-
Partners , Inc. Somerville, United States: · Come join our team and play a pivotal role in promoting and ensuring an environment where human subject research is conducted according to the highest standards · Our Team · Our Human Research Affairs Compliance and Education Office was established in June 1999 as the Quali ...
-
Senior Quality and Compliance Specialist
2 weeks ago
MMS Boston, MA, United StatesJob Description MMS is an innovative, data focused CRO that supports the pharmaceutical, biotech, and medical device industries with a proven, scientific approach to complex trial data and regulatory submission challenges. Strong industry experience, technology-enabled services, ...
-
Partners Healthcare System Somerville, United StatesCome join our team and play a pivotal role in promoting and ensuring an environment where human subject research is conducted according to the highest standards · Our Team · Our Human Research Affairs Compliance and Education Office was established in June 1999 as the Quality A ...
-
Senior Quality and Compliance Specialist
2 weeks ago
MMS Boston, MA, United StatesJob Description · Job Description · MMS is an innovative, data focused CRO that supports the pharmaceutical, biotech, and medical device industries with a proven, scientific approach to complex trial data and regulatory submission challenges. Strong industry experience, technol ...
-
Senior Quality and Compliance Specialist
1 week ago
MMS Holdings Inc Boston, MA, United StatesMMS is an innovative, data focused CRO that supports the pharmaceutical, biotech, and medical device industries with a proven, scientific approach to complex trial data and regulatory submission challenges. Strong industry experience, technology-enabled services, and a data-drive ...
-
Senior Quality and Compliance Specialist
1 week ago
MMS Holdings Inc Boston, MA, United StatesMMS is an innovative, data focused CRO that supports the pharmaceutical, biotech, and medical device industries with a proven, scientific approach to complex trial data and regulatory submission challenges. Strong industry experience, technology-enabled services, and a data-drive ...
Compliance Specialist II - Cambridge, United States - Randstad Life Sciences US
Description
Job Description
This 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.
Job Responsibilities
Education & Qualifications
Preferred Qualifications:
