Work Schedule
Flex 12 hr shift/daysEnvironmental 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, OfficeAs part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner, and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.
Position based at the Plainville, MA, site and will support the Drug Substance Division (DSD) within the Pharma Services Group (PSG).
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.
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.
Perform 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.
Bachelor's preferably in technology, engineering or microbiology, or related field preferred.
High school diploma or equivalent required.
Minimum 1 year of GMP industry related experience with a Bachelor’s Degree in Life Sciences or Chemical/Biochemical engineering or related field.
2-3 years of experience may substitute in lieu of degree.
Experience with Quality oversight of batch disposition highly preferred.
Knowledge of FDA/EMA regulatory requirements applicable to biologics or pharmaceuticals.
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.
Ability to learn and work in a cleanroom environment and to perform tasks such as gowning.
Benefits
We offer competitive remuneration, annual incentive plan bonus scheme, healthcare, and a range of employee benefits! Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation.
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