Quality Assurance Associate

Job description

Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description The Role When you are part of Thermo Fisher Scientific, you will do ambitious work, and be part of a team that values performance, quality, and innovation. As a member of a successful, growing global organization, you will be encouraged to perform at your best. With revenues of $40 billion and the largest investment in R&D in the industry, we give our people the resources and opportunities to make significant contributions to the world. As part of our global team, what you do contributes directly to our Mission:- enabling our customers to make the world healthier, cleaner and safer, alongside receiving strong support for your own career growth. Fisher Clinical Services, part of Thermo Fisher Scientific, has an unwavering commitment to service, science and process engineering, Fisher Clinical Services is powered by people with an exceptional commitment to quality, deeply instilled ethics of personal responsibility and unrivalled expertise. We are exclusively focused on serving the packaging and distribution requirements of clinical trials across the world. Whether planning, packaging, labelling, storing, or distributing the important supplies needed to perform clinical research, for more than 27 years Fisher Clinical Services has been committed to delivering the highest possible value while ensuring adherence to the highest level of quality, performance, reliability and sustainability standards. How will you make an impact? Position Summary & Key Responsibilities: We’re looking for a dynamic, detail orientated individual, to assist the Quality Assurance (QA) team to complete required reviews to ensure products are packaged to high quality standards. You’ll do this by executing daily pre-approval, post-production and supporting documentation reviews to required standards and business needs within one of the QA disciplines (Clinical or Commercial). QA Responsibilities ·         Pre-approval of Clinical or Commercial packaging orders and associated documents ·         Post-production review of Clinical or Commercial batch records ·         Execute Quality review of Clinical or Commercial supporting documentation ·         Archive – assist with archiving of Clinical or Commercial batch records ·         Perform other relevant additional duties as requested by the QA Supervisor Experience, Knowledge & Skills: ·         Understanding of GxP pharmaceutical packaging/distribution activities ·         Skilled in degree of accuracy, concentration, verbal and written communication ·         Ability to cooperate with inter department team to provide support to other colleagues ·         Ability to prioritise own workload to deliver personal and team objectives within set timeframes ·         A-level or equivalent in relevant subjects or equivalent experience required How will you get here? ·         Demonstrate behaviours in line with the Thermo Fisher Core Competencies and 4i Values. ·         Takes ownership, accepts responsibility for your actions and always make sound decisions with solid communication skills. ·         Demonstrate an adaptive and flexible work style shown to be effective working across varied types of clients, product types and front-line team members. ·         Ensure compliance with cGMP and training requirements are met in line with business need. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued. REQUIREMENTS: • Minimum 2 years experience in document control or quality systems in a regulated environment • Preferred Fields of Study: science, business administration, or related field • Relevant technical certifications in GMP/GxP documentation practices a plus • Proficiency in document management systems and quality control software (e.g., Agile, SAP, OCPLM, TrackWise) • Strong working knowledge of GMP requirements and documentation practices • Advanced Microsoft Office skills, particularly in Excel and Word • Excellent attention to detail and organizational abilities • Strong written and verbal communication skills • Ability to manage multiple priorities and meet deadlines • Experience with change control procedures and quality management systems • Additional language skills beneficial • Demonstrated ability to work independently and collaborate effectively with cross-functional teams • Experience with batch record review and documentation preferred • Knowledge of regulatory requirements in pharmaceutical/medical device industry