Senior Analyst 1, QC Compendial Testing

About the role

The Senior Analyst 1, QC Compendial Testing ensures laboratory operations are Good Manufacturing Practices (GMP)-compliant according to United States/Europe/Japan (USP/EP/JP) regulations. The role participates in the Technology Transfer (TT) of established methods into the Quality Control Laboratory as well as performs material testing and disposition using the established analytical methods.

Responsibilities

• Supports material life cycle management (new material assessment, specification establishment, maintenance of specifications etc.).
• Authors and reviews procedures, protocols, reports and specifications related to raw materials and materials requiring compendial testing.
• Performs routine and non-routine testing of incoming materials and components following compendial (USP/EP/JP) and internal methods.
• Assesses and executes actions related to change controls and vendor change notifications from partners or driven by internal or compendial needs.
• Initiates and implements Trackwise deviations, corrective and preventive actions (CAPAs), lab exceptions and invalid assays.
• Ensures adherence to company quality policies, SOPs and industry regulations while supporting maintenance of effective laboratory systems, ensuring integrity of all laboratory results, and a safe and organized laboratory environment.
• Assists in the implementation of new technologies.
• Collaborates cross-functionally with Quality Assurance, Supply Chain, Manufacturing and Contract Laboratory teams to resolve quality related issues and support manufacturing timelines.
• Performs routine investigations in support of Out-of-Specification testing results.
• Provides technical guidance and training to junior analysts and supports continuous improvement initiatives.
• Utilizes Safety data sheets (SDS's) to properly assess chemical hazards, spill response procedures and personal protective equipment (PPE) requirements if indicated.
• Performs other duties, as assigned.

Qualifications

Minimum Qualifications:

• Bachelor's degree in Chemistry, Biology, Microbiology, Biochemistry or other relevant scientific discipline with 2+ years of applicable industry experience; OR, Master's degree in Chemistry, Biology, Microbiology, Biochemistry or other relevant scientific discipline with no previous experience.
• Experience with compendial testing methodology as it pertains to cGMP.

Preferred Qualifications:

• Master's degree in Biology, Chemistry Biochemistry, Microbiology or other relevant scientific discipline with 1+ years of experience.
• 1+ years of experience in a GMP environment.
• Experience in assay troubleshooting and problem solving.
• Experience with Trackwise.

Knowledge, Skills, and Abilities

• Excellent oral and written communications skills and fluency in English.
• Computer proficiency; excellent analytical skills; ability to analyze raw data, assess assay and system suitability criteria.
• Ability to build relationships, maintain a team-based attitude, collaborate/partner with different teams and stakeholders as well as work independently.
• Ability to follow safety procedures outlined in the Chemical Hygiene Plan.
• Excellent attention to detail and organization; capability to absorb and utilize new knowledge in a fast-paced environment.
• Flexible to support a 24/7 manufacturing facility.

Physical Requirements

• Ability to inspect or perform a task with 20/20 corrected vision, visual acuity, including distinguishing color.
• Ability to stand for prolonged periods of time for up to 240 minutes.
• Ability to sit for prolonged periods of time for up to 240 minutes.
• Ability to conduct activities using repetitive motions that include wrists, hands, and/or fingers.
• Ability to conduct work that includes moving objects up to 10 pounds.
• Ability to bend, push or pull, reach to retrieve materials from 18'' to 60'' in height, and use twisting motions.
• Will work in warm/cold environments.
• Will work in small and/or enclosed spaces.