Benefits and Pay RangeBenefits for this position are available, subject to applicable eligibility requirements. These include:
- Medical, Dental, and Vision Insurance
- Company-Paid Life Insurance (equal to 1X annual salary)
- Voluntary Life Insurance Options
- Long-Term and Short-Term Disability Insurance
- Flexible Spending Account (FSA) and Health Savings Account (HSA)
- 401(K) Retirement Plan
- 10 Days of Paid Time Off (PTO)
- 10 Paid Holidays Annually
The pay range for this position is between $33.00 - $45.00 per hour. Factors which may affect starting pay within this range may include geography/market, skills, education, experience, and other qualifications of the successful candidate.
Position OverviewThe purpose of this position is to provide support services to QC and manufacturing, primarily by receiving and testing raw materials, and managing shipping of materials and products to customers and 3rd party testing labs. The QC Associate may also support the QC department by means of executing the analysis of in-process, finished product, and stability test samples. 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 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. Exceptions to the schedule must be approved by the manager in advance.
Responsibilities and Duties- Execute incoming inspection of raw materials in accordance with company policy and procedures
- Oversee sample receipt and disposition for testing within the QC lab
- Assist in the expedition of test sample shipment to sponsors and 3rd party laboratories
- Execute deviation/OOS investigations and implement CAPAs and change controls per GMP requirements, as needed
- Directly contributes to daily laboratory operations for QC Chemistry in full compliance with applicable SOPs and safety guidelines
- Occasionally analyzes in-process, release, and stability test samples in accordance with established QC test methods and specifications
- May assist in the execution of analytical method transfer activities, including product-specific test methods
- Assists QA in calibration/preventive maintenance activities associated with lab instrumentation
Requirements and Qualifications- Undergraduate degree (B.A. or B.S.) in a Life Science discipline
- Applicable academic or industrial laboratory experience
- High-level of personal and professional integrity and trustworthiness with strong work ethic and the ability to work independently with minimal direction
- 5-10 years' GMP experience in a Quality Control function within the biopharmaceutical field
- Experience with raw materials and sample management in a GMP environment
- The ability to perform daily tasks with a 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
