Senior Quality Control Analytical Chemist
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 includes processing and testing of environmental monitoring and raw material samples. QC personnel are responsible for compliance to QC policies and procedures within the QC laboratory, company policies, and cGMP guidelines. This position will report to the Director, Quality Control. This role is an 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
- A minimum of 7 years' experience in a GMP-compliant Quality Control function within the medical device and/or biopharmaceutical fields
- A high level of personal and professional integrity and trustworthiness with strong work ethic and the ability to work independently with minimal direction
- Analytical experience in the following methodologies: Buffer Characterization (pH, conductivity, osmolality), Concentration (UV/Vis and/or Fluorescence), Chromatography (HPLC, Electrophoresis)
- The ability to work effectively within cross functional teams comprised of Manufacturing, Tech Transfer, Quality Assurance, and Senior Management
- An affinity for precise and detailed documentation skills.
- The ability to effectively influence and contribute to a dynamic and fast-paced work environment
- A strong work ethic and a high level of accountability
- Strong oral and written communication and listening skills
- Excellent Problem-solving skills
Responsibilities
- Management of incoming samples utilizing a laboratory information system (LIMS) or other means.
- Perform detailed chemical analysis of samples from production, routine monitoring, stability and validation or qualification studies using compendial and non-compendial methods
- Utilize advanced instruments such as HPLC/UHPLC, SoloVPE, Maurice (cIEF and SDS Page), FTIR and UV/Vis Spectrophotometers
- Author protocols and reports including but not limited to, method qualification, method verification, method validation and method suitability.
- Apply and adhere to data integrity principals to sample handling and analysis
- Manage deviation/OOS investigations and implement CAPAs and change controls per GMP requirements
- Author and revise QC related SOPs as required
- Interface with product Sponsors on QC related inquiries.
- Participate in the review and approval of Manufacturing Batch Records for QC related activities
- Execute analytical method transfer activities, including product-specific test methods
- Train junior personnel in appropriate laboratory and safety procedures
- Execute Installation and Operational Qualification of analytical instrumentation where applicable
- Directly contributes to daily laboratory operations for QC Chemistry in full compliance with applicable SOPs and safety guidelines
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
- 10 Days of Paid Time Off (PTO)
- 10 Paid Holidays Annually
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What This Job Offers
Job Type
Full-time
Career Level
Senior
