Support quality systems as they relate to the onboarding of new QC analytical testing related to cGMP drug products. These duties include, but are not limited to document authoring and review, test method validation/verification execution and continuous improvement projects.
ESSENTIAL DUTIES & RESPONSIBILITIES
- Author and review test method validation, verification and transfer protocols.
- Execute test method validation protocols.
- Train Quality Control Chemists in new or revised test methods / procedures.
- Manage new and existing stability programs.
- Work alongside Quality Control Management, Quality Assurance, Client Pharmaceutical Services, and GRAM clients, to successfully transfer projects into the QC Analytical lab.
- Independently, or with a vendor, troubleshoot instrumentation issues.
- Perform or schedule preventive maintenance of laboratory equipment as needed.
- Qualify new laboratory equipment.
- Troubleshoot methods and complete continuous improvement projects related to existing methods.
- Work with QC Management and CPS to author and execute CAPAs and Change Controls.
- Perform data review to ensure that the client receives quality data by reviewing laboratory data for accuracy, clarity, and adherence to GMP and/or GLP regulations.
- Process data, generate reports, and evaluate data.
- Author test method protocol deviations.
- Perform all job responsibilities in compliance with cGMPs, company SOPs, and current industry practice, as applicable.
- Open to a flexible and fluid work environment. Work on any assignment as directed.
- Support Agency, customer and vendor audits as needed.
- Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company's policies and practices.
- Perform all other tasks, projects, and duties as assigned.
DESIRED SKILLS & ABILITIES
- Ability to work independently and as part of a team, self-motivated, adaptable, and possess a positive attitude.
- Ability to learn new techniques, perform multiple tasks simultaneously, keep accurate records, follow instructions, and comply with company policies.
- Ability to work with a diverse customer base.
- Ability to work well independently and in a cross-functional team environment.
- Portrays appropriate levels of integrity and professionalism.
- Excellent written and verbal skills; Ability to communicate effectively with management, staff, and regulatory agencies by exhibiting excellent interpersonal skills.
- Energetic, self-motivated, organized individual who is accustomed to working in a deadline-focused, high-pressure entrepreneurial environment.
- Results oriented and efficient; Acts with a sense of urgency.
- Creative and open-minded individual who fosters an environment in which sharing of ideas is encouraged.
- Must have proficient computer skills in Microsoft Word, Excel and Outlook.
- Ability to read and execute compendial methods from USP, and EP.
Qualified candidates possess a Bachelor's degree in Chemistry and/or other related discipline (e.g. Biochemistry, Biotechnology) and 5 years to 7 years of pharmaceutical or chemical testing experience or Master's degree and a minimum of 3 years of pharmaceutical or chemical testing experience.
GRAM supports Equal Opportunity Employment