Job DescriptionGROUP/DIVISION SUMMARYThe Drug Product Division - North America (DPD-NA) is one of the five divisions that make up the Pharma Services Group. We are made up of approximately 4400 colleagues across six sites who specialize in taking sterile injectable and oral solid dose drug products from development to commercialization.POSITION SUMMARYThe Engineer/QC Scientist II will be responsible for managing stability related project activities for both commercial and early phase products. The individual will attend customer project meetings to identify the scope of stability activities and will work directly with the customer and internal analytical representatives to craft the stability studies. The role provides direct support to ensure compliance with regulations that govern the pharmaceutical stability program.Key Responsibilities:
Managing all stability activity for projects of mid-level complexity
Writing Stability Protocols
Building Stability Frameworks in SampleManager 12 and SLIM
Coordination of batch identification, receipt, labeling and storage of stability studies
Generation and issuance of Stability Reports to the customer
Initiating billing requests for stability related activities
Communicates and coordinates with other departments as the need arises to resolve issues related to stability activities
Makes decisions regarding regulatory requirements around stability
Ensures adherence to current regulations with little dependence on others.
Education:
Bachelor’s degree required, preferably in Chemistry, Biology, or other technical science related field.
Qualifications:
3+ years of proven experience in a Quality function in the pharmaceutical industry is required. Some level of experience with stability related activity is helpful.
Equivalent combinations of education, training, and relevant work experience may be considered
Multiple digital literacy including working experience with MS office applications such as Word and Excel and general experience in computer systems associated with quality such as SOP and document review.
Very high degree of interpersonal skills to establish and maintain effective working relationships with employees and clients. Highly effective verbal and written communication skills.
Outstanding attention to detail and interpersonal skills. Self-starter, mature, independent and diligent. Ability to work in a fast-paced environment under pressure, able to multi-task and is results oriented.
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 typing. Visual acuity to use a keyboard, computer monitor, operate equipment, and read materials. Ability to sit, reach with hands and arms, talk, and hear. Safety glasses, safety shoes, lab coat, nitrile or similar gloves, safety apron, organic respirator occasionally.BENEFITSWe 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 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 with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.Apply today! http://jobs.thermofisher.comAccessibility/disability accessJob 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 1-855-471-2255. 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.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.