Submit an Application- Quality Assurance Specialist - Everett, PA - Lampire Biological Laboratories Jobs (isolvedhire.com)
Job Description:
The Quality Assurance Specialist is responsible and accountable for quality tasks and operations. Possesses and applies a broad knowledge of Quality principles, practices and procedures. Supports change control process, CAPA system, deviation process, nonconforming material process, customer complaints, supplier approval, material receiving, internal audit process ad document control. Requires experience in ISO-9001/ISO 13485 or cGMP manufacturing environment plus demonstrated familiarity with standard quality concepts..
Responsibilities Include (but are not limited to):
Position Requirements:
Qualifications based upon education, resume and/or work experience.
- Minimum of 3 years of experience.
- Excellent communication skills (English) both written and verbal
- Possess a great attention to detail.
- Must be able to work independently with minimal direction or oversight.
- Must be able to maintain accurate and organized records.
- Windows-based computer skills, familiarity with Microsoft Word and Excel
- Good organizational skills with ability to manage multiple priorities.
Responsibilities Include (but are not limited to):
- Must be able to take a leadership role in Quality related decisions.
- Proactively ensure batch records are reviewed prior to material release, ensuring paperwork is completed accurately, neatly and fully.
- Performs through root cause analysis and establishes in-depth and robust corrective and preventative actions for both internal non-conformances and customer complaints.
- Assesses materials received against internal procedures and performs the necessary approval to release materials.
- Ability to read unplanned deviations, change controls, validations and other technical documents/reports to identify errors and/or potential non-compliance issues and to assess potential product/process risk.
- Complete supplier approval paperwork for new incoming suppliers.
- Participate in internal audits and inspections including planning for audits, execution, and follow-up on audit findings.
- Assists in the tracking and maintenance of document control activities.
- Write, revise and review standard operating procedures (SOPs) and custom specifications.
- Become thoroughly knowledgeable of the applicable SOPs and maintain that knowledge base.
Education:
- 4 year college degree in quality/compliance related field or science-related field with 2-4 years related experience.
Physical Requirements:
- Must be able to lift or move up to 10lbs.
- Ability to sit, stand and walk for periods of time.
Working Conditions:
- Generally quiet office environment with minimal noise.
- May require climbing stairs in office.
- Education:
Minimum of an Associate’s degree, a Bachelor’s degree in a scientific field is preferred.
Job Benefits: Lampire Biological Laboratories offers a competitive salary, medical, dental, life, vision LTD and STD disability insurances, 401k with matching contribution and profit sharing.
Lampire Biological Labs, Inc. is an equal opportunity employer. All qualified applicants receive consideration for employment without regard to race, color, religion, sex, or national origin.