Specialist Quality Control

Summary:

The Quality Control Specialist will be supporting the Quality Control Organization. The environment is challenging, fast-paced and ever-changing with varying degrees of process definition, but very rewarding for those who like hands-on science and want to make meaningful improvements in the QC space.

Responsibilities:

Report, evaluate, trend and approve analytical data.

Troubleshoot, solve problems and communicate with stakeholders.

Generate complete, accurate, and concise documentation using electronic systems and laboratory notebook.

Participate in audits, initiatives, and projects that may be departmental or organizational in scope.

Execute protocols and perform assay transfer/validation and equipment qualification/verification. Evaluate lab practices for compliance and operational excellence improvement on a continuous basis. Providing and communicating results, maintaining/operating specialized equipment and drafting and revising documents such as Analytical Methods, SOPs and technical reports.

Collaborate cross-functionally to drive the efficient transfer of technologies and to ensure appropriate execution of procedures and processes.

Support introduction of new methods/techniques into the lab.

Perform complex assay and instrument troubleshooting.

Top 3 Must Have Skill Sets:

Experience owning Quality Records (Deviations/Change Controls)

Experience managing Stability Programs/Studies

Experience establishing/maintaining processes and procedures for sample handling and storage

Preferred Qualifications:

Knowledge of analytical methods commonly used in the quality testing of Pharmaceutical Biologics

Theoretical and practical knowledge of applying and developing separation and mass spectrometric methods for characterizing biologics

Proven record of scientific technical writing skills as demonstrated by peer-reviewed publications in science and technology journal

Experience and knowledge of Data Integrity Requirements of QC Systems

Proficient in Microsoft Office (e.g. Outlook, Word, Excel, PowerPoint)

Excellent problem-solving capabilities and attention to detail

Experience of collaboration within and across functional areas and outstanding customer service focus

Experience:

Experience with managing quality records

Technical writing is a huge plus

Compensation:

The pay rate range above is the base hourly pay range that Aditi Consulting reasonably expects to pay someone for this position (compensation may vary outside of this range depending on several factors, including but not limited to, a candidate's qualifications, skills, competencies, competencies, competencies, experience, location and end client requirements).

Benefits and Ancillaries:

Medical, dental, vision, PTO benefits and ancillaries may be available for eligible Aditi Consulting employees and vary based on the plan options selected by the employee.