Senior Quality Assurance Specialist - 2nd shift!

Essential Duties and Responsibilities:

Applies GMP/GLP in all areas of responsibility as appropriate

Applies the highest quality standard in all areas of responsibility

Demonstrates and promotes the company vision

Regular attendance and punctuality

Demonstrates strong client service skills teamwork and collaboration

Proactively plans and multitasks to maximize productivity

Meets all quality and productivity metrics and demonstrates strong teamwork and collaboration

Use opportunities to contribute to continuous quality and process improvement of QA department and of the laboratories

Demonstrate understanding of QAU operations and functions

Perform investigation writing and review including thorough root cause analysis and CAPA

Perform internal audits and walk through inspections

Review procedures methods and protocols

Release analytical reports

Host client audits appropriately respond to findings and recommendations

Provide information/entries for monthly/quarterly quality reports to management

Conducts all activities in a safe and efficient manner

Communicates effectively with clients and staff members

Take initiative to diagnose problems solve simple problems and present suggestions for solutions to complex problems

Review client or agency documents and identify requirements outside our usual practices communicate to technical operations assist with implementing appropriate changes

Keep abreast of regulatory or industry quality assurance (QA) requirements consult with clients or regulatory authorities regarding any special QA requirements they may have assist technical operations with application and interpretation of regulations

Assist and/or prepare and present training programs as needed to satisfy regulatory requirements

Serve as mentor to specialists to successfully complete assignments

Identify and drive process improvements both within the department and for laboratory operations; determine the most effective way to accomplish a goal or strategy; suggest improvements to maximize quality and productivity while remaining compliant.

Demonstrate skill in using the computer to access information perform job functions (e.g. spreadsheets power point) and prepare documents

Qualifications :

To perform this job successfully the individual must be able to independently perform the following requirements below:

• Investigation writing and review including thorough root cause analysis Technical writing and review
• Tracking action items and driving to completion
• Ability to identify trends in recurring events
• Work with the laboratory and support groups to improve quality metrics and enable CAPA implementation
• Internal audits support Review/write QAU procedures.
• Preferred Microbiology background

Basic Minimum Qualifications: 

• Bachelors degree in Biology Microbiology or related science field
• Strong computer skills including word processing spreadsheets powerpoint and databases  is preferred
• Experience in GMP environment is preferred 

Additional Information :

Position is Full-Time Monday-Friday 2nd shift with additional hours as needed. Candidates currently living within a commutable distance of Lancaster PA are encouraged to apply.

What we Offer:

• Excellent full-time benefits including comprehensive medical coverage dental and vision options

• Life and disability insurance

• 401(k) with company match

• Paid vacation and holidays

#LI-EB1

Eurofins USA BioPharma Services is a Disabled and Veteran Equal Employment Opportunity employer.

Remote Work :

No

Employment Type :

Full-time