View all jobs
Quality Assurance Senior Associate, Biopharma (JP10483)
West Greenwich, RI · Biotech/PharmaceuticalJob Title: Quality Assurance Senior Associate, Biopharma (JP10483)
Location: West Greenwich, RI. 02817
Employment Type: Contract
Business Unit: Quality
Duration: 12 months with likely extensions or conversion to permanent
Job Posting Date: 6/23/2022
Target Start Date: 7/25/2022
3 Key Consulting is hiring a Quality Assurance Senior Specialist for a consulting engagement with our direct client, a leading global biopharmaceutical company.
Job Description:
The Quality Assurance Senior Associate to be a part of our Client’s Rhode Island Quality Assurance team. The role will support the inspection, sampling, and testing of raw materials that are received at the site. This role will ensure that raw materials received for use in our cGMP manufacturing plants meet all specification requirements and master inspections characteristics required for use in our manufacturing process. This role will also demonstrate leadership skills in support of scheduling, coordination, and staff training. There will be opportunities to advance Quality learning through additional responsibilities and training.
Basic Qualifications:
Master’s degree OR Bachelor’s degree and 2 years of cGMP inspecting and/or sampling experience
Preferred Qualifications:
Why is the Position Open?
Supplement additional workload on team.
Top Must-Have Skill Sets:
Day to Day Responsibilities:
Red Flags: Lack of experience in GMP concepts
Interview process:
Phone screening followed by in-person interview.
We invite qualified candidates to send your resume to recruiting@3keyconsulting.com. If you decide that you’re not interested in pursuing this position, please feel free to look at the other positions on our website www.3keyconsulting.com/careers. You are welcome to also share this opportunity with anyone you think might be interested in applying for this role.
Location: West Greenwich, RI. 02817
Employment Type: Contract
Business Unit: Quality
Duration: 12 months with likely extensions or conversion to permanent
Job Posting Date: 6/23/2022
Target Start Date: 7/25/2022
3 Key Consulting is hiring a Quality Assurance Senior Specialist for a consulting engagement with our direct client, a leading global biopharmaceutical company.
Job Description:
The Quality Assurance Senior Associate to be a part of our Client’s Rhode Island Quality Assurance team. The role will support the inspection, sampling, and testing of raw materials that are received at the site. This role will ensure that raw materials received for use in our cGMP manufacturing plants meet all specification requirements and master inspections characteristics required for use in our manufacturing process. This role will also demonstrate leadership skills in support of scheduling, coordination, and staff training. There will be opportunities to advance Quality learning through additional responsibilities and training.
Basic Qualifications:
Master’s degree OR Bachelor’s degree and 2 years of cGMP inspecting and/or sampling experience
Preferred Qualifications:
- Strong understanding of cGMP regulations and GDP requirements
- SAP, LIMs, LMES, Maximo and TrackWise experience
- Experience with RAMAN technology
- Experience in raw material inspections, sampling, and testing
- Strong written and verbal communication skills
Why is the Position Open?
Supplement additional workload on team.
Top Must-Have Skill Sets:
- Strong understanding of cGMP regulations and GDP requirements
- Strong written and verbal communication skills
- Experience in raw material inspections, sampling, and testing
- Bachelor’s degree and 2 years of cGMP inspecting and/or sampling experience
Day to Day Responsibilities:
- Inspect materials including biobags, tubing, filters, and other components to ensure all inspection-related specification requirements and master inspections characteristics are met
- Collect samples from a statistical number of containers for all chemicals to facilitate the testing of samples
- Use RAMAN technology with TruScan and NIR equipment to identify chemicals
- Ensure that inspection & sampling results are complete and detailed according to written procedures, specifications and cGMP requirements
- Responsible for accurately documenting inspection, sample, and test results in the systems
- Responsible for ensuring that characteristics that could potentially impact product quality are assessed according to procedures
- Ability to determine the color of raw materials match required attributes
- Support inspection readiness activities including site audits and inspections
- Maintains project plan commitments supporting critical projects
- Support Continual Improvement initiatives, programs and projects
- Own controlled documents for the area including SOPs and FORMs
- Initiate and own deviation records and CAPAs associated with events and projects in ARI’s raw material inspections, samples, and testing areas
Red Flags: Lack of experience in GMP concepts
Interview process:
Phone screening followed by in-person interview.
We invite qualified candidates to send your resume to recruiting@3keyconsulting.com. If you decide that you’re not interested in pursuing this position, please feel free to look at the other positions on our website www.3keyconsulting.com/careers. You are welcome to also share this opportunity with anyone you think might be interested in applying for this role.
Regards,
3KC Talent Acquisition Team