Senior Quality Control Analytical Lab Associate
About The Position
The purpose of this position is to provide support services by means of executing the analysis of in-process, finished product, and stability test samples. Further support services include Environmental Monitoring and Raw Material receipt activities. QC personnel are responsible for compliance with QC policies and procedures within the QC laboratory, company policies, and cGMP guidelines. This position will report to the Supervisor, Quality Control. This role is 100% on-site position Monday - Friday 8 hours/day (excluding lunch break). Overtime, weekends and holidays may be required. Flexible start time between 7:00 am - 9:00 am with a consistent schedule.
Requirements
- Undergraduate degree (B.A. or B.S.) in a Life Science discipline
- Analytical experience in the following methodologies: Buffer Characterization (pH, conductivity, osmolality), Concentration (UV/Vis and/or Fluorescence), Chromatography (HPLC, Electrophoresis).
- High-level of personal and professional integrity and trustworthiness with strong work ethic and the ability to work independently with minimal direction
- The ability to work effectively within cross functional teams comprised of Manufacturing, Tech Transfer, Quality Assurance, and Senior Management
- 5+ years' GMP experience in a Quality Control function within the medical device and/or biopharmaceutical fields
- The ability to perform daily tasks with keen attention to detail
- An affinity for precise and detailed documentation skills
- The ability to work effectively and contribute to a dynamic and fast-paced work environment
- Well-developed oral communication and listening skills
Responsibilities
- Analysis of samples using a variety of analytical instrumentation and compendial methods
- Performing analytical method transfers and qualifications
- Troubleshooting analytical method performance
- Assist in the expedition of test sample shipment to sponsors and 3rd party laboratories
- Manage deviation/OOS investigations and implement CAPAs and change controls per GMP requirements
- Directly contributes to daily laboratory operations for QC Chemistry and Microbiology, in full compliance with applicable SOPs and safety guidelines
- Manage incoming inspection of raw materials in accordance with company policy and procedures
- Analyzes on a routine basis in-process, release, and stability test samples in accordance with established QC test methods and specifications
- Train QC personnel in appropriate laboratory and safety procedures
- Execute Installation and Operational Qualification of analytical instrumentation where applicable
- Author and revise QC related documents, study reports and batch records as required
- Interface with Sponsors on QC related inquiries
Benefits
- Medical, Dental, and Vision Insurance
- Company-Paid Life Insurance (1x Annual Salary)
- Voluntary Life Insurance Options
- Short-Term and Long-Term Disability Insurance
- Flexible Spending Account (FSA) & Health Savings Account (HSA)
- 401(k) Retirement Plan with Company Matching
- 14 Days of Paid Time Off (PTO)
- 10 Paid Holidays Annually
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Number of Employees
101-250 employees
