Senior Associate Quality Control - Days

What we expect of you

Preferred Qualificationsnice to have

• Experience in HPLC, GC, ICP-MS and/ or GC-MS
• Demonstrated laboratory technique with pipetting small volumes accurately
• Professional work experience in a fast-paced, flexible GxP laboratory
• Experience executing analytical testing per Methods and/or Compendia
• Experience with QC analytical systems and/or Quality systems
• Excellent interpersonal, written and verbal communication skills with all levels within the organization
• Ability to work in a team matrix environment and build relationships with partners
• Experience leading teams or projects
• Identify, manage, and champion innovative projects to advance productivity and enable LEAN principles across different functions
• Experience in auditing and defending processes, procedures and decisions during regulatory inspections
• Demonstrated innovative thinking and ability to transform work organizations
• Strong communication skills (technical writing and oral), facilitation and presentation skills
• Exposure to Operational Excellence initiatives
• Demonstrated ability to navigate through ambiguity and provide a structured problem solving
• Demonstrated ability to deliver on schedule.

Responsibilities include

• Perform testing methods including HPLC, GC and GC-MS
• Perform testing and data analysis for compendia, non-compendia methods, and routine laboratory procedures
• Perform routine and non-routine evaluations and data review
• Generate accurate and concise laboratory documentation using electronic systems and notebooks
• Operate and maintain specialized laboratory equipment and instrumentation
• Participate in laboratory investigations, inspections and audits
• Stay in sync with safety guidelines, cGMPs and other applicable regulatory requirements
• Support training of new staff as applicable
• Ensure facilities, equipment, materials, organization, processes, procedures and products align with cGMP practices and other applicable regulations
• Perform review and approval of procedures, assays, documents and records, including but not limited to deviation records and CAPAs
• Alert management of quality, compliance, supply and safety risks
• Completes required assigned training to permit completion of required tasks
• Support Continual Improvement initiatives, programs and projects.
• Ensure that changes that could potentially impact product quality are assessed according to procedures.

What you can expect of us

• A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts

• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan

• Stock-based long-term incentives

• Award-winning time-off plans

• Flexible work models where possible. Refer to the Work Location Type in the job posting to see if this applies.