QC Analytical Analyst, Raw Materials Testing
About The Position
We are seeking a Quality Control (QC) Analytical Analyst, to ensure that manufactured products meet established quality, safety, and regulatory standards. The daily QC activities include raw material, intermediate product and final drug product release testing of sterile injectable radiopharmaceutical products used to detect and treat cancer. Additional laboratory duties include performing stability testing, analytical method transfers and analytical method validations. Qualified Analysts are expected to provide training on testing protocols and safety measures for junior staff members. The QC Analytical Analyst will have the opportunity to draft documents related to these efforts as well. This position is based in Springfield, NJ and requires a presence on-site five days per week, and open to applicants authorized to work for any employer within the United States. This role will be on First Shift (approximately 8 AM – 5 PM).
Requirements
- Bachelor’s degree in Chemistry or Biochemistry required
- Minimum of 3+ years of applicable GMP laboratory experience required
- Radiopharmaceutical experience preferred.
- Experience using analytical techniques, such as High-Performance Liquid Chromatography (HPLC) and radio-Thin Layer Chromatography (rTLC).
- Strong organizational, and problem-solving skills while working under strict timelines.
- Ability to convey complex ideas in a simple manner to management and customers, exercise independent judgement during method development/transfer processes.
- Knowledge of analytical methods currently used for testing, release, and stability of sterile pharmaceutical products.
- Team oriented mindset and demonstrates ability to work easily with cross functional teams.
- Fluent in Microsoft Word and experienced in working with laboratory information management systems (LIMS).
Nice To Haves
- Strong written and oral communication skills, as well as the ability to critically review and interpret quality event investigations.
- Understanding of quality risk management strategies, as well as demonstrated ability to continuously improve the QMS and manufacturing/testing operations.
- Skilled at initial interpretation of issues and effectively communicating such issues to Upper Management for further consideration.
- Ability to lead quality initiatives that enhance site QMS, and adjacent activities.
- Ability to work efficiently when working independently on quality-related tasks.
- Ability to implement corrective and preventive actions on the shop floor, with assistance from cross-functional team members.
- Ability to quickly recognize conflicts/issues and notify management with proposed recommendations for resolution.
- Ability to verbally communicate updates, problems, projects, and any required information clearly to all audiences.
- As this job involves working within proximity to radiation, the individual must have a “safety-first” mindset.
Responsibilities
- Perform Raw Material Sampling
- Perform USP ID testing, both chemical and instrumentation
- Perform QC release and stability testing on drug products
- Execute experimental protocols, SOP’s, etc., consistent with cGMP/GLP.
- Validate analytical procedures to meet QC’s needs.
- Adapt, maintain, and operate analytical instrumentation.
- Develop and transfer analytical methods to and from QC and contract manufacturers as assigned by management.
- Adhere to all safety requirements.
- Conduct radiation safety duties conforming to regulations.
- Participate in department meetings via input, feedback, and execution of assigned tasks.
- Ensure the work environment is clean, safe and in compliance with safety and pharmaceutical regulations.
- Report monthly on supplies for QC orders involving devices and reagents.
- Participate in laboratory investigations and root-cause analyses.
- Prepare chemical reagents for manufacturing and QC.
Benefits
- comprehensive health benefits package that includes medical, prescription drug, dental, and vision coverage.
- life and disability benefits
- pre-tax accounts
- a 401(k) with company contribution
- a variety of other benefits.
- generous time off package including paid vacation, holidays, sick days, and paid parental leave.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
