"All candidates must be directly contracted by ASK Consulting on their payroll and cannot be subcontracted. We are unable to provide sponsorship at this moment".

Job Title: Quality Records Specialist

Location: Summit, NJ

Duration: 12 months

Pay rate: $34.45/ hr on W2

Job Description:

• This role will partner cross functionally with Global Product Quality, External Manufacturing Supply Chain, and Global Supplier Quality to release vector in a timely manner for commercial, clinical and early development programs.

Required Competencies:

Knowledge, Skills, and Abilities:

• Experience with deviation and change control management, preferably with Infinity systems.
• Strong organizational skills, including ability to follow assignments through to completion.
• Ability to work in a fast paced environment, meet deadlines, and prioritize work from multiple projects.
• Excellent verbal and written communication skills, and ability to work within inter-disciplinary and cross-functional teams.
• Detail oriented with demonstrated application in problem solving.
• With moderate oversight from manager, think strategically and understand global impact of decisions.

Desired competencies:

Knowledge, Skills, and Abilities:

• Advanced project management skills such as process excellence/six sigma methods and approaches including process mapping, root cause analysis and problem definition.
• Experience within the Cellular Therapeutics and/or gene-based products. Experience with biologics will be considered.
• Experience with Clinical and/or Commercial products manufacture, supply and post-approval change management.
• Knowledge of applicable FDA/EMA regulations in the biotechnology industry.
• Experience managing external suppliers and other supply chain issues.
• Experience with Quality Systems (change control, deviation and investigation).

Qualifications & Experience:

• Minimum 3 years experience. Minimum bachelors degree required.
• 3+ years in QA.
• Create and revise SOPs.

About ASK : ASK Consulting is an award-winning technology and professional services recruiting firm servicing Fortune 500 organizations nationally. With 5 nationwide offices, two global delivery centers, and employees in 42 states-ASK Consulting connects people with amazing opportunities

ASK Consulting is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all associates.