Quality Assurance Specialist

The Quality Specialist I is responsible for providing Quality Assurance oversight and support within a GMP-regulated manufacturing environment. This role ensures compliance with applicable Standard Operating Procedures (SOPs), FDA, EU, and ICH regulations, and internal quality system requirements. The Quality Specialist I plays a key role in maintaining product quality, ensuring regulatory compliance, and supporting continuous improvement of the site's quality management system.

This position requires on-the-floor presence in manufacturing and cleanroom environments and supports quality operations across production, documentation review, investigations, and compliance activities.

*
* Location:

** Plainville, MA

*
* Employment Type:

** Temporary (minimum 1-year)

** Pay Rate:**  $34.50/hr. (32.20/hr.)

** Shift:
** Night Shift (Flex 12 Rotating Schedule)

+ Week 1:
Monday, Tuesday, Friday, Saturday

+ Week 2:
Sunday, Wednesday, Thursday

+

Hours:

6:45 PM - 7:15 AM (30-minute unpaid meal break)

** Key Responsibilities*
* + Provide on-the-floor Quality Assurance oversight of GMP manufacturing operations.

+ Review executed batch records and GMP documentation for accuracy, completeness, and compliance with established procedures.

+ Support investigations, deviations, CAPAs, and change control activities under the direction of senior QA personnel.

+ Identify, escalate, and document quality events, compliance risks, and non-conformances in a timely manner.

+ Partner with Manufacturing, Quality Control, and cross-functional teams to ensure adherence to GMP requirements.

+ Support internal audits, client audits, and regulatory inspection readiness activities.

+ Maintain working knowledge of applicable GMP regulations, site procedures, and quality systems.

+ Ensure proper documentation practices and compliance with electronic quality systems.

+ Contribute to continuous improvement initiatives within the quality management system.

** Qualifications*
* ** Education*
* + Bachelor's degree preferred in Life Sciences, Microbiology, Engineering, Technology, or related field.

+ Equivalent combinations of education, training, and relevant work experience may be considered.

** Experience*
* + Minimum 1+ year of GMP industry experience required (with Bachelor's degree in Life Sciences or related field preferred).

** Knowledge, Skills, and Abilities*
* + Working knowledge of FDA, EMA, and applicable GMP regulations.

+ Understanding of GMP manufacturing operations and quality systems.

+ Familiarity with deviations, CAPAs, investigations, change controls, and risk management processes.

+ Strong attention to detail with ability to review complex GMP documentation.

+ Excellent written and verbal communication skills.

+ Strong organizational, problem-solving, and time management skills.

+ Ability to work independently and escalate issues appropriately.

+ Proficiency with electronic quality systems and Microsoft Office applications.

+ Ability to work effectively in a fast-paced regulated environment.

** Physical Requirements*
* + Routine presence in GMP manufacturing and cleanroom environments requiring PPE use.

+ Ability to gown and comply with controlled environment procedures.

+ Frequent standing, walking, and computer-based work.

+ Ability to lift up to 25 pounds occasionally.

+ Visual acuity required for document review and quality inspections.

+ Ability to work night shifts and support non-standard hours as needed.

** Additional Details*
* + Role requires strict adherence to GMP compliance and site quality standards.

+ Strong emphasis on documentation accuracy and regulatory readiness.

+ Position supports manufacturing quality operations and continuous improvement initiatives.

+ Night shift rotating schedule with extended 12-hour shifts.

** Why work for Adecco?*
* + Weekly Pay

+ 401(k) Plan

+ Skills Training

+ Excellent medical, dental, and vision benefits

Benefit offerings include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits and 401K plan. Our program provides employees the flexibility to choose the type of coverage that meets their individual needs.  Available paid leave may include Paid…