Quality Assurance Associate

Work Schedule

Environmental Conditions

Job Description

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:

Were 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. Youll 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 100000 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