Supervisor, Chemistry

Cardinal Health•Mansfield, MA

2d•Onsite

About The Position

Quality develops and implements quality policies, procedures, and processes to ensure products and services comply with regulatory standards and specifications. Chemistry performs laboratory testing to characterize the chemical properties of our medical device and pharmaceutical products. This job family develops and executes test protocols using specialized instrumentation and analytical techniques to assess chemical properties of finished drug products, medical devices, materials, processing aids, and the chemical constituents which may be released when a device is used in a clinical setting as well as the stability of pharmaceutical products.

Requirements

4-8 years of experience
Possesses working knowledge of USP, FDA, and ICH and ISO regulatory requirements as applicable to pharmaceutical stability testing
Possess a thorough understanding of Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP) to ensure compliance of systems and procedures

Nice To Haves

Bachelor’s degree in related field preferred or equivalent work experience.
Experience with Quality Management Software (QMS), such as Veeva or Agile and compliance software like Laboratory Information Management System (LIMS), such as LabWare, preferred
Prior experience leading a team of analysts and scheduling laboratory testing, preferred
Experience with authoring standard operating procedures (SOPs), work instructions, and other documentation contributing to continuous improvement initiatives, preferred
Strength in authoring and reviewing analytical method transfer, qualification and validation/verification protocols and reports, preferred
Experience with pharmaceutical testing techniques such as HPLC, UV-vis spectroscopy, Karl Fischer titration, and dissolution preferred

Responsibilities

Plan and schedule work according to laboratory needs.
Participate in laboratory budgets planning, including ordering equipment and supplies, ordering consumables, and tracking costs.
Serves as a department representative in cross-functional working teams and/or working with outside customers to meet stability testing needs.
Ensure all testing is conducted according to cGMP principles.
Review analytical method verification, validation and analytical method transfer protocols following the regulatory requirements (ICH, USP and FDA).
Participate in investigations of Out of Specification (OOS) test results as needed follow FDA guidelines.
Manage and maintain compliance with relevant regulatory requirements (e.g. ICH and FDA) related to testing and data documentation.
Maintain a clean, safe work environment, comply with safety policies, and dispose of waste according to local, state, and federal regulations.
Ensure that the laboratory equipment and instruments are in good working conditions to perform analytical testing and minimize down time.
Collaborate with cross-functional teams to discuss stability concerns and address issues.
Monitor, track, and publish metrics and react to key process performance indicators (KPI).
Identifies areas for improvement and drives projects to implement solutions.
Train and mentor chemists in the department for continued improvement in the areas of technical knowledge, productivities and regulations.
Coordinates and supervises the daily activities of operations or business staff.
Administers and exercises policies and procedures.
Ensures employees operate within guidelines.