QA Specialist III - Batch Release

Work Schedule

Environmental Conditions

Job Description

POSITION SUMMARY

In this position youll drive quality execution across the sterile operations including manufacturing filling packaging and inspection and associated non batch specific activities in for both commercial and product development services products. Additionally this position will provide quality guidance and expertise for implementation of practical process improvements and continuous improvement initiatives.

Key Responsibilities:

• Perform daily quality assessments of facility personnel and documentation both classified and non-classified areas to uncover errors or deficiencies assure quality and compliance per site procedures and cGMPs.
• Daily interaction with employees to assist with troubleshooting documentation corrections/notes and guidance with aseptic technique
• Champions quality culture by aiding personnel in understanding application of policies and controls
• Participates in RAPID event response and provides quality guidance for deviation events
• Advances deviation events to the appropriate area and quality management
• Performs quality review and approval of procedures training documents and forms of moderate to high complexity
• Performs quality review and approval of deviation and change control of moderate to high complexity
• Participates as the quality assurance representative in Root Cause Analysis to support deviation investigations of moderate to high complexity
• Performs quality batch record review
• Aids in identification of continuous improvement opportunities; Participates in practical process improvement initiatives

Qualifications:

• Bachelors degree required preferably in technology engineering or microbiology related field.
• 4 years of experience with previous experience in Quality Assurance or Quality control or Operations/Manufacturing
• Equivalent combinations of education training and relevant work experience may be considered
• Previous experience in pharmaceutical industry; preferably aseptic or steriles processes strongly preferred experience in other regulated environments may be considered (i.e. ISO 9001)
• Effective time management and prioritization skills.
• Good interpersonal skills to establish and maintain effective working relationships with employees and the public including tact to handle sensitive matters.
• Good verbal and written communication skills (legible handwriting).
• Good Presentation Skills.
• Demonstration of active listening skills.
• Ability to troubleshoot process and equipment issues
• Self-driven demonstrated ownership & responsibility
• Ability to lead support & motivate a team
• Ability to learn Technical Writing experience
• Professional certifications (ex: CQA) and training (Six Sigma) is a PLUS
• Ability to develop solutions that are mutually beneficial to the client and to Thermo Fisher.
• Ability to function independently and as part of a team.
• Demonstrated Commitment to our fundamental principles of Integrity Respect and excellence.
• Understanding of the Quality systems and investigation documentation
• Ability to adapt to a changing environment quickly and easily
• Ability to respond disciplined and rationally under pressure
• Ability to display command authority and remain firm in complex situations

Physical Requirements:

Position requires ordinary ambulatory skills and physical coordination sufficient to move about office locations. Ability to stand walk stoop kneel crouch periodically for prolonged periods of time Manipulation (lift carry move) of light to medium weights of 10-35 pound pounds. Arm hand and finger dexterity including ability to grasp and type for prolonged periods of time. Visual acuity to use a keyboard computer monitor operate equipment and read materials for prolonged periods of time. Ability to sit reach with hands and arms talk and hear for prolonged periods of time. Safety glasses safety shoes lab coat nitrile or similar gloves safety apron organic respirator occasionally.

BENEFITS

We offer competitive remuneration annual incentive plan bonus 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!

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 with PPD part of Thermo Fisher Scientific where diverse experiences backgrounds and perspectives are valued.

Apply today!

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race color religion sex sexual orientation gender identity national origin protected veteran status disability or any other legally protected status.

Accessibility/disability access

Job Seekers with a Disability: Thermo Fisher Scientific offers accessibility service for job seekers requiring accommodations in the job application process. For example this may include individuals requiring assistance because of hearing vision mobility or cognitive impairments. If you are a job seeker with a disability or assisting a person with a disability and require accessibility assistance or an accommodation to apply for one of our jobs please submit a request by telephone at 1-*. Please include your contact information and specific details about your required accommodation to support you during the job application process.

This telephone line is reserved solely for job seekers with disabilities requiring accessibility assistance or an accommodation in the job application process. Messages left for other purposes such as not being able to get into the career website following up on an application or other non-disability related technical issues will not receive a response.