Senior Associate Quality Control - Days
About The Position
The Senior Associate Quality Control performs raw material testing using sophisticated instrumentation, manages samples and data, and operates and maintains laboratory equipment in a dynamic team environment. The role works under minimal supervision and supports quality control activities in accordance with cGMP practices and applicable regulatory requirements. The position includes performing analytical tests and data reviews, documenting work in electronic systems and notebooks, participating in investigations and audits, supporting training and continual improvement, and ensuring that potential impacts to product quality are assessed according to procedures.
Requirements
- High school diploma or GED and 4 years of Quality experience, or an associate's degree and 2 years of Quality experience, or a bachelor's degree and 6 months of Quality experience, or a master's degree.
- Detail-oriented.
Nice To Haves
- Experience in HPLC, GC, ICP-MS, and/or GC-MS.
- Demonstrated laboratory technique, including accurately pipetting small volumes.
- 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.
- Ability to identify, manage, and champion innovative projects to advance productivity and enable LEAN principles across different functions.
- Experience auditing and defending processes, procedures, and decisions during regulatory inspections.
- Demonstrated innovative thinking and ability to transform work organizations.
- Strong technical writing, oral communication, facilitation, and presentation skills.
- Exposure to Operational Excellence initiatives.
- Ability to navigate ambiguity and provide structured problem solving.
- Demonstrated ability to deliver on schedule.
Responsibilities
- 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.
- Follow 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.
- Review and approve procedures, assays, documents, and records, including deviation records and CAPAs.
- Alert management to quality, compliance, supply, and safety risks.
- Complete required assigned training to permit completion of required tasks.
- Support continual improvement initiatives, programs, and projects.
- Ensure changes that could potentially impact product quality are assessed according to procedures.
Benefits
- Health and welfare plans for staff and eligible dependents
- Retirement and Savings Plan with generous company contributions
- Group medical coverage
- Dental coverage
- Vision coverage
- Life insurance
- Disability insurance
- Flexible spending accounts
- Discretionary annual bonus program, or a sales-based incentive plan for field sales representatives
- Stock-based long-term incentives
- Award-winning time-off plans
- Flexible work models where possible
- Career development opportunities
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What This Job Offers
Job Type
Full-time
Career Level
Senior
Education Level
High school or GED
