The Quality Associate supports the Quality Function that they are responsible for within Operations.

• This could include: Incoming Quality Assurance of drugs and packaging materials, Manufacturing Quality Assurance, Validation, Quality Engineering, Training and Regulatory Compliance.
• Expectations that the Quality Associate will maintain high quality levels on all aspects of their job while achieving high levels of efficiency.

Responsibilities :

• Responsible for various aspects of quality assurance and quality control related to their functional area.
• Ensures that product within the plant is consistently manufactured in conformance with company Quality System requirements and all applicable regulatory requirements.
• Support troubleshooting and resolution of quality compliance issues.
• 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 company Quality Systems and cGMPs.

Qualifications :

• Must be familiar with use of electronic document management and laboratory information management.
• Must also be familiar with Quality Systems as well as cGMP and other regulatory requirements.
• Strong communication skills, both oral and written

Are you open to look at candidates willing to relocate? n/a

Years of experience/education and/or certifications required:

• Bachelor’s Degree/ 2+ years of combined experience in Manufacturing, QA, QC, R&D in pharmaceutical or biologics industry

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

• Whether it is through manufacturing or quality control, a certain level of quality experience is necessary.
• some form of review experience: data or record review
• 1+ years within a manufacturing facility

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

• Bonus: some work with investigations
• Bonus: experience with document revisions
• Bonus: review of GMP commercial batch records

Daily Work Schedule Expectations Monday to Friday 9-5 or 10-6 is ideal

Job Type: Contract

Pay: $25.00 - $30.00 per hour

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Health insurance
• Life insurance
• Paid time off
• Vision insurance

Experience level:

• 3 years

Schedule:

• 8 hour shift
• Monday to Friday

Work setting:

• In-person

Education:

• Bachelor's (Preferred)

Experience:

• Documentation management: 2 years (Preferred)
• investigations: 3 years (Preferred)
• quality assurance: 3 years (Preferred)
• pharma or biotech or medical device industry: 2 years (Preferred)

Ability to Commute:

• Worcester, MA 01602 (Required)

Work Location: In person