Let’s do this! Let’s change the world! In this vital role, 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.
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.).
Bachelor's degree 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).
Previous experience with either synthetic or biologic stability program management (e.g., designing studies, authoring stability study documents, reviewing data monthly and annually, coordinating with Supply Chain/Manufacturing groups to obtain samples, collaboration with Quality Control testing groups, etc.,).
Strong project management skills.
Understanding of biologic and synthetic pharmaceutical bulk and drug product manufacturing and analytical techniques.
General knowledge of cGMP and US and international filing regulations pertaining to the manufacture and testing of pharmaceuticals and/or bio-pharmaceuticals.
Experience using computer software such as MS Office (i.e., Excel, Word, Project), LIMS, document management systems, regulatory application systems, etc.
Experience working on a cross-functional team in a matrix environment.
Excellent written and verbal communication skills, including facilitation and presentation skills.
Top 3 Must Have Skill Sets:
Stability Study Design
Data Analysis
Technical Writing
GMP or previous pharmaceutical experience
Must have a degree; science background is preferred
About Us: Established in 2004, SPECTRAFORCE® is one of the largest and fastest-growing diversity-owned staffing firms in the US. The growth of our company is a direct result of our global client service delivery model that is powered by our state-of-the-art A.I. proprietary talent acquisition platform, robust ISO 9001:2015/ISO 27001 certified processes, and strong and passionate client engaged teams. We have built our business by providing talent and project-based solutions, including Contingent, Permanent, and Statement of Work (SOW) services to over 140 clients in the US, Canada, Puerto Rico, Costa Rica, and India. Key industries that we service include Technology, Financial Services, Life Sciences, Healthcare, Telecom, Retail, Utilities and Transportation. SPECTRAFORCE is built on a concept of “human connection,” defined by our branding attitude of NEWJOBPHORIA®, which is the excitement of bringing joy and freedom to the work lifestyle so our people and clients can reach their highest potential. Learn more at: http://www.spectraforce.com
Benefits: SPECTRAFORCE offers ACA compliant health benefits as well as dental, vision, accident, critical illness, voluntary life, and hospital indemnity insurances to eligible employees. Additional benefits offered to eligible employees include commuter benefits, 401K plan with matching, and a referral bonus program. SPECTRAFORCE provides unpaid leave as well as paid sick leave when required by law.
Equal Opportunity Employer: SPECTRAFORCE is an equal opportunity employer and does not discriminate against any employee or applicant for employment because of race, religion, color, sex, national origin, age, sexual orientation, gender identity, genetic information, disability or veteran status, or any other category protected by applicable federal, state, or local laws. Please contact Human Resources at LOA@spectraforce.com if you require reasonable accommodation. At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $45.00/hr.
