Work Schedule

Flex 12 hr shift/days

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Office

Job Description

How will you make an impact?

The QA Specialist’s primary responsibility is to ensure quality and compliance at VVS Thermo Fisher’s Plainville, MA clinical manufacturing site with respect to relevant Standard Operating Procedures, applicable Regulatory requirements (FDA, EU, ICH), and current industry standards and practices. The individual will work together with professional Quality Assurance personnel to support internal and external customers in matters of product quality. The incumbent is encouraged to improve and maintain a quality culture with a goal of consistency.

What will you do?
To perform this job efficiently, the individual must have sound knowledge and experience in the application of current Good Manufacturing Practices, United States Pharmacopoeia, current Code of Federal Regulations.
  
The Individual performs on-the-floor Quality Assurance activities supporting cGMP production and provides routine updates on outstanding commitments.

•    Ensures the quality of and supports all GMP manufacturing activities.
•    Review of completed batch records in accordance with specified timelines. 
•    Performs robust document review and approval activities to meet specified timelines and ensure the adherence to Quality Agreements. Documentation may include batch records, SOPs, investigations, corrective actions, change controls, technical documents, 
•    Provides support on investigations related to manufacturing, utility, equipment, and process activities.  Reviews and assesses criticality of events/investigations as required by the applicable procedure and client quality agreements.

•    Provides support for change controls, exceptions and CAPAs as needed.
•    Works collaboratively with manufacturing, QC, Facilities & Engineering and cross-functional partners to complete exception investigations, CAPAs and Change controls appropriately.
•    Supports Quality by performing other documentation review or QA compliance activities, including audits, as needed.
•    The employee will be required to gown into a cGMP aseptic manufacturing facility. Required to sit and stand for extended periods. The employee is occasionally required to lift, stand; walk; use hands to finger, handle, or feel; reach with hands and arms; and stoop, kneel, or crouch.

How will you get there? 
Education
Bachelor's preferably in technology, engineering or microbiology, or related field preferred. High School Diploma or equivalent is required. Equivalent combinations of education, training, and other relevant work experience accepted.

Experience
Minimum 1+ years GMP industry related experience.

Knowledge, Skill, and Requirements:
Knowledge of FDA/EMA regulatory requirements applicable to biologics or pharmaceuticals. Experience with Quality oversight of batch disposition.
Excellent organizational skills and analytical and problem-solving abilities, strong verbal and writing skills and good interpersonal skills.
Possesses outstanding time management and multi-tasking abilities to meet commitments.

Excellent Benefits

Benefits & Total Rewards | Thermo Fisher ScientificMedical, Dental, & Vision benefits-effective Day 1Paid Time Off & Designated Paid HolidaysRetirement Savings PlanTuition Reimbursement

OTHER

Relocation assistance is NOT providedMust be legally authorized to work in the United States now and in the future, without sponsorship.Must be able to pass a comprehensive background check, which includes a drug screening.