Specialist Quality Assurance (JP7623)
West Greenwich, RI. (Onsite Essential)
ARI Quality Operations
6+ months (with likely extensions)
3 Key Consulting is hiring a Specialist Quality Assurance
for a consulting engagement with our direct client, a leading global biopharmaceutical company.
We have two positions – 2nd
shift. 2nd shift (Tues-Fri 1pm to 11pm) and 3rd shift (Tues-Fri 10pm to 8am). The ideal candidate will have quality system experience. Someone who’s worked on deviation records and has been able to make decisions based on this. Drug substance manufacturing experience is a plus.
The Specialist will be responsible for Quality Oversight on-the-floor in support of Manufacturing activities. This position provides the opportunity to work directly with Manufacturing staff during bulk drug substance operations to facilitate real-time decision-making regarding quality requirements and deviations. This is a unique opportunity to foster a strong partnership and learning environment between Manufacturing and Quality staff. Clients’s Quality Assurance On-the-Floor position provides coaching, guidance and direction to Manufacturing, Quality Control and Facilities & Engineering staff in regard to compliance and quality systems.
Why is the Position Open?
Additional workload on the team.
Top Must-Have Skill Sets:
Day to Day Responsibilities:
- Previous QA oversight of manufacturing, analytical and engineering activities.
- Experience in investigations and quality systems process knowledge (beginner to intermediate level of experience).
- Biotechnology quality assurance/manufacturing experience (insight into quality assurance) (beginner to intermediate level).
- Ability to gather relevant information to understand and solve complex problems and make scientific risk-based decisions. (troubleshooting experience/problem solving/ to best provide a quality assurance concepts).
- Demonstrated proficiency of written and verbal communication skills with ability to communicate and collaborate effectively with peers, manufacturing partners, and management staff.
- This role requires a high level of communication as there are 20 people working over 5 shifts so the candidate will need to be able to effectively communicate what was done and be able to pick up and ask questions from the previous shift.
Employee Value Proposition:
- Responsible for providing Quality oversight to ensure that operations products are manufactured, tested, stored, and distributed according to current Good Manufacturing.
- Practices (cGMP), Good Documentation Practices (GDP) and other applicable regulations.
- Ensures that facilities, equipment, materials, organization, processes, procedures and products comply with cGMP practices and other applicable regulations.
- Performs review and approval of cGMP processes, procedures, documents and records, including but not limited to Standard Operating Procedures (SOP), Batch Records, Nonconformance, and Corrective Action/Preventative Actions (CAPA) records.
- Establish and enable LEAN practices.
- Ensures that deviations from established procedures are investigated and documented per procedures.
- Ensures that production records and testing results are complete, accurate, and documented according to written procedures and cGMP requirements.
- Alerts senior management of quality, compliance, supply and safety risks.
Not a desk job. This is a quality role partnership with manufacturing on their floor to insure we are compliant to FDA regulations that is safe and effective - going out of the door as should - cross collaboration between quality assurance teams and manufacturing teams (10-12 people).
- Quality Control Laboratory experience ONLY is not a good fit.
- We are looking for Quality Assurance experience.
- Must have a minimum of 2 - 3 years GMP industry experience in either a Manufacturing or Quality Assurance role.
- An introvert will not be the best fit - cross collaboration is big factor in this role!
Video Skype Panel Interview.
We invite qualified candidates to send your resume to firstname.lastname@example.org
. If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.