Job Title: Specialist Product Quality, Biopharma - Remote (JP9961) Location: West Greenwich, RI. (Remote) Employment Type: Contract Business Unit: Stability Program Management Duration: 3 years with possible conversion to FTE Posting Date: 03/21/2022
3 Key Consulting is hiring a Specialist Product Quality for a consulting engagement with our direct client, a leading global biopharmaceutical company.
As a Specialist Stability you will provide support to the Product Quality (PQ) organization as a subject matter expert of clinical and commercial product stability studies and GMP data management. In this team-based role, you will directly add to the success of a Product Quality Team by collaborating with diverse functional areas including Supply Chain, Manufacturing, Quality Control, Regulatory, Quality Assurance, Quality Engineering, International Quality and Process Development on projects, issue resolution and investigations.
The Specialist Stability builds and monitors stability studies within quality systems (e.g. LIMS), owns and handles product quality and stability data and may serve as a primary author on regulatory filings and directly participate in and support site-based GMP inspections. Additional responsibilities include business process support, such as SOP authoring and management, or gap assessments to regional regulations. Expertise in project management, time management and successfully navigation skills for matrixed team environments are essential.
Master’s degree & 3 years of Quality, Operations, Scientific, or Manufacturing experience, or
Bachelor’s degree & 5 years of Quality, Operations, Scientific, or Manufacturing experience
B.S. or advance degree in chemistry, biochemistry, biology, or a related pharmaceutical sciences field and
Experience with growing responsibility in a quality, analytical development, process development,pharmaceutics, regulatory, or manufacturing environment
Experience working in a regulated environment (either direct GMP or technical support)
Strong project management skills
Understanding of biologic and synthetic pharmaceutical bulk and drug product manufacturing andanalytical techniques
General knowledge of cGMP and US and international filing regulations pertaining to the manufacture andtesting of pharmaceuticals and/or bio-pharmaceuticals
Experience working on a cross-functional team in a matrix environment
Excellent written and verbal communication skills, including facilitation and presentation skills
Why is the Position Open? Backfill
Top Must-Have Skill Sets:
Stability Study Design
GMP or previous pharmaceutical experience
Must have a degree; science background is preferred
Day to Day Responsibilities: Key Responsibilities include:
• Build and maintain technical GMP documents and product stability studies
• Review, verify, report, and archive GMP data for clinical and commercial products
• Apply keen attention to detail to conduct data review and reports
• Execute transactions in relevant GMP computer-based systems (change control, LIMS, etc.)
• Adeptly manage time-sensitive activities independently
Employee Value Proposition: Flexible work hours/time zones. Two workers from this role recently converted to permanent so there is a great potential for long term employment beyond this 3 year contract duration.
Red Flags: No degree
No pharmaceutical experience
No analytical experienc
Interview process: Phone screening followed by Video 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 position, please feel free to take a 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.