- Applies Good Manufacturing Practices (cGMP) in all areas of responsibility.
- Demonstrates and promotes the company vision.
- Performs approval of specifications and incoming inspections on material (i.e. drug, components) and distribution shipments.
- Performs material and process inspections and samplings.
- Review and approve Packaging Electronic Production Orders.
- Participates in continuous improvement initiatives and assists with root cause investigations for nonconforming issues.
- Author's, revises, and complies with all relevant SOP's and Work Instructions and properly documents activities when necessary.
- Resolve and assure that issues potentially affecting product quality/compliance are escalated to the attention of the Team Leader and/or Management.
- Assures that issues are resolved in a timely manner and corrective actions are implemented accordingly.
- Performs all activities in a safe and efficient manner.
- Other duties may be assigned to meet business needs.
- High school diploma or equivalent required, with 2 years experience
- Associates degree preferred.
- A minimum of 1 year of experience in Pharmaceutical or of a related, regulated industry and a high school diploma.
- Familiar with Quality Systems (Change Control, deviations, complaint manage
- Must be able to work in a refrigerated environment (35F to 46F) with provided protective wear.
- Must be able to work in a freezer (-20F) environment with provided protective wear.
- Must be able to work in potent compound suites with provided protective wear (PPE).
- Good reasoning and problem-solving skills, basic math skills, good communication skills, basic computer skills.
- Must be willing to work various shifts and overtime depending on business needs.
- Must be able to work independently.
- Mastery of skills required to read, understand, and adhere to the SOPs and policies of a GMP environment.
- Must not be allergic to penicillin or cephalosporin products.
- Extensive standing and walking on packaging floor in order to monitor room activities.
- Work schedule, Monday through Friday, 8 hours per day. Additional overtime and weekend (Saturday or Sunday) work may be required.
- This position requires standing, bending and lifting. Exerting and lifting up to 25lbs of materials occasionally, and 10lbs of materials regularly.
- The position is exposed to cold temperatures for more than one hour at a time.
- The position is exposed to -20F temperatures for at least 15 minutes at a time.
- The position will be exposed to atmospheric conditions could require special personal protection equipment.
- Incumbent must meet applicable visual acuity/color blindness standards to perform visual inspections in a cGMP environment
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Lead QC Technician - Allentown, United States - Thermo Fisher Scientific
Description
Job Description
Lead QC Technician - 2nd Shift
As part of the Thermo Fisher Scientific team, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world's toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.
A day in the Life:
Keys to Success:
Education
Experience
Knowledge, Skills, Abilities
Physical Requirements
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.
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 *. 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.