QC Specialist, I-Investigations

Thrive in the dynamic and challenging environment of a contract development and manufacturing organization. Driven to excel through self-leadership and thriving team engagement. If this describes you, then look no further than LSNE. We have the experience, expertise and a successful track record in completing development of life-changing pharmaceuticals and medical devices. Together with our clients, we work to bring about treatment of many forms of cancers, Diabetes, communicable diseases, and many other illnesses. Come make a difference. Your work will matter and your contributions will be significant in these endeavors.

We offer a competitive compensation and benefits package and a very generous paid time off benefit. Join our team!

JOB SUMMARY-

The QC Specialist's primary responsibility is to perform data analysis of environmental monitoring and facility monitoring data, and write quarterly trend reports to summarizing these data. Perform and author investigations for environmental monitoring excursions and deviations which occur during routine and aseptic operations. Write and revise cGMP documentation. Assist with corrective action plans.

JOB DUTIES -

• Trend environmental monitoring data and preparation of trend reports
• Write and revise cGMP documents and technical reports to meet industry standards
• Initiating deviations/OOS/EEIs, CAPAs, and non-conformance investigations
• Perform data analysis and data review
• Other duties as necessary

PROFESSIONAL SKILLS -

• Proficient in Microsoft Office including Word, Excel and PowerPoint
• Excellent written and oral communication skills are required; proficiency in English language

EXPERIENCE -

• 1-3 years of GMP experience, including investigation, environmental trend reports, CAPAs
• Experience in pharmaceutical aseptic operations preferred

EDUCATION -

• BS/BA Degree in Scientific/Technical field (Microbiology preferred)

QUALITIES -

• Self-motivated and ability to work with minimal supervision
• Ability to meet aggressive deadlines while multi-tasking; excellent organizational and interpersonal skills

• Must be able to walk and drive between locations
• Ability to sit or stand for prolonged period of time
• Able to work in a highly complex environment with competing demands and priorities
• Able to deal with ambiguity

• Works closely with quality assurance, operations, and facilities staff

• None

TRAVEL -

• <10%. Travel generally consists of routine daily movement between buildings.

The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of personnel so classified.

Recommended Skills

• Communication
• Corrective And Preventive Action (Capa)
• Data Analysis
• Data Quality
• English
• Environmental Monitoring