Quality Control Chemist
Tedor is a small customer-focused oral solid dose CDMO with a strong track record of meeting aggressive development and commercialization timelines for small to mid-size pharma companies. Over the past 16 years we have helped our customers receive many product approvals, including 10 in the last 3 years. We attribute this success to our company-wide focus on quality, customer service and meeting timelines. Everything we do, and how we do it, is focused on helping you to achieve your product objectives. In short- we are small enough to care and experienced enough to deliver.
The role of the Quality Control Scientist is responsible for supporting the operations and manufacturing process by performing routine and non-routine analytical chemistry assays of raw materials, finished formulations, stability samples, client-based & company-based pharmaceutical projects, method development and/or transfers, and cleaning study qualifications.
This is a full-time, non-exempt position that includes a competitive salary, stock option package, and strong benefits. The Quality Control Scientist will report directly to the Quality Control Manager.
- Perform In-Process, Finished Product and Stability testing using HPLC, GC, Dissolution, and wet chemistry techniques
- Perform raw materials analysis using USP/NF or in-house development testing methods.
- Perform timely instrument qualification as they are due
- Perform all assigned tasks in a timely and organized manner in accordance with cGMP, GLP, and company policies & procedures
- Provide training and assistance to other group members
- Investigate and troubleshoot analytical problems, write OOS reports, Deviation reports, and CAPA reports
- Have the capability to work on multiple projects in a fast-paced environment
- Maintain good cGMP practices by following detailed SOPs, maintain training, laboratory notebooks, and good documentation practices
- Operated and maintain all analytical instrumentation & equipment as per established procedures
- Perform calibrations and preventative maintenance of laboratory instruments, including completing appropriate documentation
- Maintain a safe and clean working environment by performing routine area housekeeping and reporting unsafe conditions
Position Type & Expected Hours of Work
This is a full-time, non-exempt position requiring a minimum of 40 hours of work per week, Monday through Friday. Some responsibilities may require work outside of normal office hours.
Level 2: Office Environment and Laboratory Environment
The work environment characteristics described here are representative of those a teammate encounters while performing the essential functions of this role and within the daily operations of a professional office environment. Reasonable accommodations may be made to enable employees with disabilities to perform essential functions.
This job operates in a professional office environment, as well as the laboratory environment. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets, as well as standard laboratory equipment and instrumentation. An employee in this role will be exposed to standard hazards founds within a laboratory environment such as chemicals; bloodborne pathogens; fumes; select agents; confined spaces. Proper laboratory attire and safety gear such as protective eyewear; laboratory coat; appropriate gloves must be observed.
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
This role requires standard physical demands within a standard office and laboratory environment where sustained periods of standing, sitting, or walking will be part of an employee’s daily routine, whether they are at their desk or in the laboratory. While performing the duties of this role, an employee is regularly required to talk or hear; use hands or fingers to handle or feel; reach with arms; bend or stoop; climb stairs; crawl or crouch; kneel; push or pull; type on a keyboard; use a computer mouse. Lastly, an employee must be able to lift ten (10) pounds.
No travel expected.
Required Education & Experience
- Bachelor of Science degree in Chemistry or related Physical Sciences
- A minimum of two – four (2 – 4) years of laboratory experience in the pharmaceutical industry in Quality Control, Development, or Research & Development/Analytical Research & Development
- A minimum of two – four (2 – 4) years of experience in the laboratory testing of pharmaceutical/biologic products in a GMP environment
- Proven experience in the QC testing of pharmaceutical/biologic products in a GMP environment
- Demonstrated collaborative skills are essential
Preferred Education & Experience
- Experience working closely with manufacturing and development teams
- Proficient with Microsoft Office
- Excellent interpersonal, verbal, and written communication skills
- Is comfortable in a fast-paced, small company environment with the ability to adjust workload based upon changing priorities and business needs
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. All duties, responsibilities, and activities may be subject to change at any time with or without notice.
Tedor Pharma, Inc. is proud to be an Equal Employment Opportunity and Affirmative Action employer. All aspects of employment including the decision to hire, promote, discipline, or discharge, will be based on merit, competence, performance, and business needs. We do not discriminated based upon race, religion, color, marital status, national origin, gender, sexual orientation, gender identity, gender expression, age, status as a protected veteran, ancestry, medical condition, pregnancy, genetic information, status as an individual with any mental and/or physical disabilities, or any other status protected under federal, state, or local law.
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