Quality Assurance

Title : Quality Assurance

Duration : 12 Months (Potential Extension)

Location : : J23, 1675 Lakeside Drive

Job Description and Qualifications :

Description :

This individual will work in the Global Quality System & Strategic Transformation organization supporting global

projects and initiatives. Activities include all aspects of project management for Drug Shortage Prevention Plans

DSPP), creation of deliverables, working with stakeholders and driving technical enhancements. The individual

will directly work with the Global Quality Risk Management team and be responsible for establishing and maintaining records.

DSPP work involves active collaboration with a cross-functional team in manufacturing sites,

external manufacturing, regulatory, supply chain, product quality, compliance, and other global functions.

This global function includes monitoring, tracking, and supporting various efforts and initiatives in the Quality System.

Responsibilities :

• Lead meetings to facilitate and / or support the DSPP Project.
• Actively collaborate with a cross-functional team to complete project milestones and DSPPs per

established timeline.

• Assist the functional areas on completing the DSPP risk factors and input in the DSPP.
• QA review of DSPP content in compliance with established governing documents.
• Oversee, monitor and track key deliverables associated with DSPP Implementation Project Metrics and related initiatives.
• Support other DSPP Project deliverables or initiatives as requested.

Qualifications :

• Bachelor's degree in Chemistry, Pharmacy, Biology, Microbiology, Engineering, or other technical / scientific area.
• Minimum of 5 years of experience in Quality Assurance and / or Quality System oversight.

Risk Management, supply chain, compliance and drug shortages experience preferred.

Lead meetings with technical professionals and experience in leading cross-functional teams with a

results-orientated approach.

Preferred :

Knowledge of regulatory documents such as ICH, US / EU and other key GMP regulations.

Skills : Result-oriented, strong oral and written communication skills, excellent interpersonal skills,

initiative, attention to details, time management in a fast-paced environment, teamwork, problem solving

and project management.

Computer system skills including Microsoft Office; proficient in Power Point and Excel.

What are the top 3-5 skills, experience or education required for this position :

1. Project Manager (Pharma)

2. Quality Assurance experience (Pharma); more than 5 years

3. Experience in Quality Risk Management, compliance, drug shortages

Benefits : SPECTRA FORCE offers ACA compliant health benefits as well as dental, vision, accident, and hospital indemnity insurances.

Additional benefits SPECTRA FORCE offers to the eligible employees include commuter benefits, 401K plan with matching and a referral bonus program.

SPECTRA FORCE offers unpaid leave as well as paid sick leave when required by law.

Equal Opportunity Employer : SPECTRA FORCE 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 [email protected] if you require reasonable accommodation.