QC Technician II
Thermo Fisher Scientific
Job Info
Job Description
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.
Location/Division Specific Information
Location: Bohemia, NY
Hours: Monday - Friday; 8:00am - 4:30pm
How you will make an impact...
The In-Process Inspector is responsible for verifying that customer and internal manufacturing design specifications are followed in the creation of clinical labels. Responsibilities include translations, label design and client service processes associated with the clinical label creation.
What you will do...
- Perform visual and software inspection of all label proofs and associated documents, translation, and regulatory documentation (Translation work orders, order reports, excel results, client text and protocols), and randomizations, link reports, sample configurations, finished goods and replacement label requests.
- Inspection processes performed include but are not limited to plate ready's, text compare, replacements, and change notice to assure CGMP's are met and performed according to customer specifications and regulatory requirements.
- Use camera inspection software program to detect potential label text and documentation errors.
- Correct documentation by noting and forwarding deficiencies to be corrected, tracking correction of deficiencies and verify corrections prior to approval.
- Identify, reject, and report non-compliance documentation.
- Release and approve inspected documents from inspections for customer final approval.
- Responsible for reviewing and update the daily schedules and workflow in the In Process Inspection (IPI) department and ensuring that all inspections are completed on time and in accordance with customer requirements.
- Communicate with the group leader, Project Managers and Project Support Associates during processing, and follow job completion.
- Maintain official documentation related to errors and trending for IPI, translations, Client Service and Label Design, reporting this information monthly to the Manager of Client Services - IPI.
- Assist with organizing, revising, and implementing SOP's, WI's, and Maser Forms.
- Ensure all relevant Standard Operating Procedures (SOPs), Work Instructions (WIs), master forms and Customer protocols are being followed in accordance with current Good Manufacturing Practices and company SOPs and WIs. This includes ensuring all current procedures and processes are being followed within the department.
- Provide suggestions and improvements to the department regarding work-related processes and procedures.
- Advise management to needs associated with increased efficiencies and quality.
- Other duties may be assigned to meet business needs.
Education
- High School Diploma or GED
- 2+ years' experience in a quality/ FDA cGMP environment
- 2+ years' proof-reading experience
- Computer Literate with experience and knowledge of Microsoft Word and Excel
- 2+ years of pharmaceutical or clinical experience preferred
- Excellent interpersonal skills (written and oral communication)
- Comprehension of label and customer specifications
- The ability to work with confidential information
- Attention to detail
- Excellent time management skills: the ability to manage timelines
- Works well in a fast-paced, high-pressure environment
- The ability to work effectively and accurately in busy open floor plan environment
- Adaptability to change
- Applies Good Manufacturing Principles in all areas of responsibility
- Demonstrates and drives the Thermo Fisher values - Integrity, Intensity, Involvement, and Innovation (The Four I's).
- Conduct all activities in a safe and efficient manner
Excellent Benefits Package
- Review our company's Total Rewards
- Medical, Dental, & Vision benefits-effective Day 1
- Paid Time Off & Holidays
- 401K Company Match up to 6%
- Tuition Reimbursement - eligible after 90 days
- Employee Referral Bonus
- Employee Discount Program
- Recognition Program
- Charitable Gift Matching
- Company Paid Parental Leave
- Career Advancement Opportunities
At Thermo Fisher Scientific, each one of our 100,000+ outstanding minds has a unique story to tell. Join us and contribute to our unusual mission-enabling our customers to make the world healthier, cleaner and safer.
Apply today! http://jobs.thermofisher.com
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. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
Compensation and Benefits
The hourly pay range estimated for this position based in New York is $18.00-$24.00.
This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes:
- A choice of national medical and dental plans, and a national vision plan, including health incentive programs
- Employee assistance and family support programs, including commuter benefits and tuition reimbursement
- At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy
- Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan
- Employees' Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount
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