Qc Analyst Jobs

About The Position

Requirements

• Ability to handle multiple tasks concurrently and complete tasks in a timely manner.
• Effective organizational skills and ability to plan and suggest resolutions to technical problems.
• Demonstrates some knowledge of assays/equipment in functional area.
• Computer literate and competent with a general knowledge of word processing and spreadsheets (such as Microsoft Office).
• Proficient use of laboratory equipment and tools.
• Must be detail-oriented, conscientious, and responsible.
• Must have effective verbal and written communication skills.
• Some knowledge of applicable CTP/SOPs, EHS requirements, FDA Regulations application of CGMP/GDPs.
• Must be able to learn new computer systems and programs in a timely manner.
• Applicants must be authorized to work for any employer in the U.S. We are unable to sponsor or take over sponsorship of an employment visa at this time.

Nice To Haves

• Bachelor’s degree in the life sciences and experience with a medical device/pharma, or other similarly regulated industry, preferred.

Responsibilities

• Perform routine environmental monitoring for cleanrooms, compressed gas systems and water systems.
• QC Data entry in Sample manager- BaxLIMS
• Complete all testing, including special project / protocol testing in a timely and appropriate manner.
• Perform equipment maintenance and calibrations as required.
• Maintain data integrity and ensure compliance with company SOPs and specifications, FDA, GLP, QSR and cGMP regulations.
• Perform/or support all NCRs, CAPAs, and LIRs and be the point of contact for other departments for updates.
• Participate in functions involving teams, which impact production, increase efficiency, solve problems, generate cost savings, and improve quality.
• Perform laboratory and manufacturing audits as required.
• Audit and update, as required, plant/lab SOPs.
• Ensure Environmental Monitoring area is always maintained in a GMP state while following all EHS and 6S guidelines.
• Flexibility to perform other duties, as assigned, or as business needs require.
• Works and communicates effectively and professionally with others inside and outside the company.

Benefits

• medical and dental coverage that start on day one
• insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance
• Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount
• 401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching
• Flexible Spending Accounts
• educational assistance programs
• paid holidays
• paid time off ranging from 20 to 35 days based on length of service
• family and medical leaves of absence
• paid parental leave
• commuting benefits
• Employee Discount Program
• Employee Assistance Program (EAP)
• childcare benefits