Quality Associate

12 month contract with possible extension

Purpose :

• The Sr Quality Associate II provides leadership and direction to the Quality Function that they are responsible for within Operations.
• This role is responsible for the effective implementation of the Quality functions within operations for which they would be responsible for.
• This could include: Incoming Quality Assurance of drugs and packaging materials, Manufacturing Quality Assurance, Validation, Training, Regulatory Compliance, Quality Planning, Product Quality and strategic initiatives.
• The Sr Quality Associate II would be expected to work within a budget and leads a team who are responsible for compliance and quality systems implementation.
• Expectations that the Sr. Quality Associate II will maintain high quality levels on all aspects
• of their job while achieving high levels of efficiency.

Responsibilities :

• Leads and influences peers and colleagues within the scope of their work.
• Responsible for various aspects of quality assurance related to products produced at the plant.
• Responsible for the effective organization, administration, and training within their functional area.
• Independently troubleshoot and resolve quality compliance issues.
• Provides regulatory and technical guidance to departments.
• Communicates with Management for Quality Management Review, Quality Initiatives, etc.
• Incumbent is responsible for quality decisions related to their functional area to ensure compliance with
• Client Quality Systems and cGMPs.

Qualifications:

• Bachelor’s Degree required; preferably in Physical or Life Sciences, Pharmacy, or Engineering
• 4 years of combined experience in Manufacturing, QA, R&D in pharmaceutical, biologics, device or chemical industry
• Must be familiar with use of electronic document management and laboratory information management.
• Must also be familiar with Client Quality Systems as well as cGMP and other regulatory requirements.
• Strong communication Skills, both oral and written

Years of experience/education and/or certifcations required:

• Bachelor’s Degree required, preferably in Physical or Life Sciences, Pharmacy, or Engineering
• 4 years of combined experience in Manufacturing, QA, R&D in pharmaceutical, biologics, device or chemical industry

What are the top 3-5 skills requirements should this person have?

• Strong understanding of FDA regulations for drugs and medical devices
• Strong attention to detail
• Ability to work in various IT programs, word, excel, powerpoint, sharepoint sites
• Strong communication skills, both written and oral
• Evaluation of complaints for reportability requirements

What is a nice to have (but not required) regarding skills, requirements, experience, education, or certification?

• Pharma experinece
• Recall experience

Job Types: Full-time, Contract

Pay: $26.00 - $30.00 per hour

Schedule:

• 8 hour shift

Application Question(s):

• Bachelor’s Degree required, preferably in Physical or Life Sciences, Pharmacy, or Engineering

Education:

• Bachelor's (Preferred)

Experience:

• FDA regulations: 4 years (Preferred)
• Quality control: 4 years (Preferred)
• Quality inspection: 4 years (Preferred)
• Pharma industry: 4 years (Preferred)

Work Location: One location