Description
JOB SUMMARY
Responsible for supporting support and managing quality systems as they relate to the manufacturing and testing of cGMP drug products.
ESSENTIAL DUTIES & RESPONSIBILTIES
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.
Manage day to day prioritization of routine, in-process, stability, and finished product work.
Manage staff schedules to ensure over-time/weekend coverage for manufacturing support.
Work with management to maintain working schedule of all work flowing through the QC Analytical Lab.
Comply with all laboratory safety guidelines, both written and implied. Inform management
of any safety concerns.
Lead training of all new employees and maintain all training documentation via current system.
Support the OOS system, Laboratory Investigations, and assist in any related CAPAs, non-conformances, etc.
Work with management to deliver staff performance evaluations, develop individual goals, address performance and progress via routine 1x1 meetings.
Oversight of all laboratory chemical and equipment use.
Establish and maintain good technique with regards to working in an aseptic environment.
Independently author or edit internal test methods and standard operating procedures.
Perform all job responsibilities in compliance with cGMPs, company SOP's, and current industry practice.
As needed, perform physical, chemical, and instrumental analysis of active pharmaceutical ingredients, excipients and finished pharmaceutical products.
Open to a flexible and fluid work environment. Work on any assignment as directed.
Support GRAM's Core Values of Quality, Service, Collaboration, and Courage.
Support Agency, customer and vendor audits as needed.
Perform all other tasks, projects, and duties as assigned
Requirements
DESIRED SKILLS & ABILITIES
Strong attention to detail.
Ability to complete tasks with accuracy and efficiency.
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.
Consistently/Frequently - see (vision), hear, ability to read and write, ability to interpret information, basic math, reading and writing in English.
Energetic, self-motivated, organized individual who is accustomed to working in a deadline[1]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.
Ability to work well independently and in a cross-functional team environment.
Ability to learn new techniques, perform multiple tasks simultaneously, keep accurate rd records, follow instructions, and comply with company policies.
Ability to work with a diverse customer base.
Ability to manage 4 to 8 lab personnel effectively.
Ability to problem solve and make decisions that are GMP compliant.
Must have proficient computer skills in Microsoft Word, Excel and Outlook.
Ability to read and execute compendia methods from USP-NF, EP, BP etc.
Qualified candidates have a Bachelor's degree in Chemistry and/or other related discipline (e.g. Biochemistry, Biotechnology) and a minimum of 5 years pharmaceutical or testing experience. Previous leadership experience preferred.
GRAM supports Equal Opportunity Employment
