Compliance Specialist - Level 3 US- First Shift - Randstad USA

job summary:

As the largest staffing and recruitment agency in the world, we can commit to finding you the perfect role that gives you the opportunity to learn and grow in the life sciences arena. Utilizing a recruiter for your job search gives you access to a large network of top employers as well as detailed information about hundreds of positions. Focusing on immune diseases like HIV that affect a large percentage of the population, the work our longtime partner conducts is imperative to a better, healthier future. To be recognized as a crucial part to furthering this goal, join this growing team now!

 
location: Cambridge, Massachusetts
job type: Contract
salary: $72.00 - 74.73 per hour
work hours: 9 to 5
education: Bachelors
 
responsibilities:

• 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.
  
  

  Job 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 the company 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:

• Required 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 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.

  Preferred Qualifications:

  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.

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