Lead QA Technician - Batch Release
Lead QA Technician - Batch Release
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Salary Not Disclosed
1 Vacancy
Job Description
Work Schedule
First Shift (Days)Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards Office Some degree of PPE (Personal Protective Equipment) required (safety glasses gowning gloves lab coat ear plugs etc.)Job Description
As part of the Thermo Fisher Scientific team youll 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 worlds toughest challenges like protecting the environment making sure our food is safe or helping find cures for cancer.
Excellent Benefits Package
Review our companys 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
Location/Division Specific Information
Greenville NC
Hours: 8am-5pm Mon - Fri (OT as needed)
GROUP/DIVISION SUMMARY
The 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 SUMMARY
The Lead QA Technician provides direct quality support to ensure compliance with regulations that govern pharmaceuticals. Ensure the site can operate without regulatory actions that impede product quality cause product stoppages or reduce customer satisfaction.
What will you do
- Champions quality culture by aiding personnel in understanding the application of policies and controls.
- Advances deviation events to the appropriate area and quality management
- Perform processes and projects of moderate complexity ensuring adherence to current regulations with little dependence on others.
- 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 makes determinations as to whether work performed meets current procedures and regulatory expectations.
- Communicates and coordinates with other departments as required to resolve issues and compliance concerns detected during review.
- Conducts risk assessments and takes 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 batch disposition (release) decisions.
Qualifications:
- High School diploma/GED required. Minimum of 3 years of proven experience; or
- Associates degree with a minimum of 2 years of experience; or
- Bachelors degree with a minimum of 1 year of experience.
- Degrees in Computer science Chemistry Biology or other technical or physical/life science preferred.
- Equivalent combinations of education training and meaningful work experience in Quality Assurance may be considered
- Previous experience in the pharmaceutical industry; preferably aseptic or sterile processes strongly preferred
- Good verbal and written communication skills (legible handwriting).
Required Experience:
IC
Employment Type
Full-Time
