POSITION SUMMARY:

The Quality Control Lead oversees the development and implementation of standards, methods and procedures for inspecting, testing and evaluating the precision, accuracy and functionality of products.

RESPONSIBILITIES:

• Write, revise, review and/or approve QC documentation
• Conduct routine and non-routine analysis of raw materials, in-process and finished formulations according to SOP’s and WI’s
• Compile data for documentation of test procedures and prepares reports
• Review data obtained for compliance to specifications and report abnormalities
• Perform a wide variety of inspections, checks, tests and sampling procedures for the manufacturing process
• Records detailed observations, analyzes data and interprets results
• Support QC material management including labeling, storage, lot control, inventory hold and release procedures
• Monitors critical equipment and instrumentation.
• Serve as a subject matter expert for various analytical procedures related to ArcherDX products
• Work with various departments to establish QC specifications for new products
• Leads component and finished product stability and validation projects
• Additional duties as assigned

QUALIFICATIONS:

• Minimum 3-5 years related industry experience
• GMP experience as it pertains to the life sciences/pharmaceutical industry
• Experience leading a team
• Excellent organizational and leadership skills

KEY ATTRIBUTES:

• Attention to detail and desire for quality
• Strong time management skills (schedules, timelines, task prioritization) and the ability to adapt to changing priorities
• Excellent multi-tasking and problem-solving skills; solution-oriented; self-motivated
• Ability to participate with others as a member of the team to ensure success of cross-departmental projects, while, maintaining strong relationships within all parts of company

EDUCATION:

• BS/MS/PhD in molecular biology, biochemistry or related field and/or equivalent combination of education and experience