Vacancy expired!
Job Title: Lead QA Technician QA Specialist IWhen you’re part of the team at Thermo Fisher Scientific, you’ll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and you’ll be supported in achieving your career goals.Location/Division Specific InformationWe have industry leading sterile injectable facilities providing solutions to take essential product from Pre-Clinical to the market. Pharmaceutical products come in many different dose forms including inhalations, oral dose, cream/ointments and injectables.How will you make an impact?Provides direct quality support to ensure compliance with regulations that govern pharmaceuticals for laboratories. Ensures the site operates in compliance with regulatory standards that ensures product quality, avoids stoppages and reinforces customer satisfaction.What will you do?Processes and projects of moderate complexity, perform compliance assessments, make decisions regarding regulatory requirements; ensure adherence to current regulations with little dependence on others.
Provides internal and external customer support (as needed)
Provides leadership and team participation as assigned for assignments related to quality initiatives and compliance improvements, product transfers, facility expansions, etc.
Performs document reviews and make determinations as to whether work performed meets current procedures and regulatory expectations. Communicate and coordinate with other departments as required to resolve issues and compliance concerns detected during review.
Conducts risk assessments and take appropriate actions during quality oversight activities (e.g. during review/approval) to ensure adequate controls in relation to the level of product quality, safety and business risks.
Performs QA decisions.
Performs QA Client release decisions
Comply with all job-related safety and other training requirements.
Perform other duties as assigned.
How will you get here?Associate Degree required, preferably in technology, engineering, scientific related field or related field.Bachelor degree in related field (Computer science, Chemistry, Biology, or other technical or physical/life science) is preferred.0-2 years of related experience if candidate has obtained a bachelor degree.2-3 years of related experience if candidate has an associate degree. Preferably in direct interaction with operations/laboratory or related STEM experience.Experience in Quality Assurance, Quality control or Operations/Manufacturing in a regulated industry and direct interaction with operations/laboratory is preferred. Equivalent combinations of education, training, and relevant work experience may be considered if at least an Associate degree is obtained.Knowledge, Skills, AbilitiesVery high degree of interpersonal skills to establish and maintain effective working relationships with employees and the public, including tact to handle sensitive matters.Highly effective verbal and written communication skills.Outstanding attention to detail and organizational skills.Self-starter, mature, independent and dependable.Demonstrated ability to mentor professional staff in order to achieve goals, evaluate and resolve complex technical problems.Ability to command authority and remain firm in complex situations.Ability to motivate, energize, and retain key staff by direct interactions with supervisors and staff.Self-starter, mature, independent and dependable. Ability to work in a fast-paced environment under pressure, able to multi-task and is results-oriented.Requires discretion and independent judgment. Very high degree of interpersonal skills to establish and maintain effective working relationships with employees and the public, including tact to handle sensitive matters.Ability to respond disciplined and rationally under pressure.Multiple computer skills including working experience with MS Office applications such as Word and Excel and general experience in computer systems associated with quality systems such as lot review, SOP review and approval, lab results reviews (LIMS), disposition of product and validation document reviews.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 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.At Thermo Fisher Scientific, each one of our 70,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer.Apply today! http://jobs.thermofisher.comThermo 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.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.
Vacancy expired!