QA Specialist

1 month ago

Worcester, United States Infobahn Softworld Inc Full time

**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

**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

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