Associate Scientist, Quality Control

Sigmapharm Laboratories, LLC; Northern (KY); Hybrid; USD 55,000 - 75,000; Full time

Job summary

Sigmapharm Laboratories, LLC seeks an Associate Scientist in Quality Control to perform analytical testing of raw materials, in-process samples, and released products in a GMP-regulated laboratory environment.

You will record experimental data, support method development and validation, calibrate instruments, and ensure documentation compliance with CGMP and FDA guidelines while collaborating with QA and manufacturing to support product releases.

Qualifications

• BS in Chemistry or Pharmaceutical Sciences required with 1–3 years of pharma lab experience.
• Experience with CGMP compliance and documentation.
• Strong analytical mindset and data interpretation skills.

Responsibilities

• Perform physical and chemical testing of materials and products.
• Record data, analyze results, and maintain notebooks.
• Maintain lab compliance with SOPs, FDA/CGMP guidelines.
• Operate and calibrate HPLC, GC, UV-VIS, IR equipment.
• Assist in method development and validation work.
• Prepare technical documents and SOP revisions as needed.

Skills

Verbal and written communication

Multi-tasking

CGMP experience

Data analysis

Detail oriented

Education

BS in Chemistry or Pharmaceutical Sciences

Tools

HPLC

Dissolution

GC

UV-VIS

IR

Job description

All Jobs > Associate Scientist, Quality Control

DUTIES AND RESPONSIBILITIES – PRIMARY ROLE:

• Perform physical and chemical testing of raw material, packaging material, in-process, release, and stability samples.


• Record experimental data, analyze results, and maintain accurate and up-to-date notebooks.


• Assist in maintaining the laboratory in compliance with SOPs, CGMPs, FDA, OSHA and other guidelines.


• Assist in filing laboratory documents.


• Use and maintain instruments, such as HPLC, GC, Dissolution, UV-VIS, IR, Titrator, etc.


• Troubleshoot and perform minor maintenance and repair of lab instrumentation.


• Support investigation and troubleshooting of analytical issues.


• Carry out duties in compliance with all state and federal regulations and guidelines including FDA, DEA, EPA and OSHA.


• Support ANDA/NDA projects from development to approval with guidance.


• Support method development and method validation work.


• Perform calibration and maintenance of various analytical equipment.


• Assist in writing technical documents (for example specifications, test methods, protocols and reports).


• Periodically review SOPs for compliance with CGMP and revise SOPs, if necessary.


• Execute EQ protocols and set up qualification program for new instruments with some guidance.


• Perform calibration and maintenance of various analytical equipment.


• Assist in preparing documents for ANDA/NDA filing.


• Provide formal/informal mentoring to technicians.

DUTIES AND RESPONSIBILITIES – SECONDARY ROLE:

• Maintain laboratory in clean and organized condition.


• Order, receive and maintain a record of chemicals and lab supplies.


• Perform regular inspection of chemical storage areas to ensure the proper storage of chemicals and to remove expired chemicals from storage.


• Packaging all samples to be sent out.


• Dispose laboratory organic waste and solid waste timely manner.


• Assist in filing of laboratory documents.

Requirements

ABILITIES/SKILLS:

• Strong verbal and written communication skills.


• Demonstrated proficiency with General Chemistry and various analytical instruments (HPLC, Dissolution, GC, UV-VIS, IR, etc.)


• Ability to multi-task and prioritize.


• Prior experience with CGMP.


• Must be capable of performing routine / new procedures with minimal direct supervision.


• Must be able to understand technical terminology, names of drugs and ingredients used.


• Must have good understanding of basic statistics and be able to analyze/plot data in an understandable fashion.

EDUCATION/EXPERIENCE:

• BS in Chemistry or Pharmaceutical sciences with 1-3 years of relevant pharma laboratory experience.

PHYSICAL DEMANDS:

• Light work (exerting up to 20 pounds of forces occasionally, and/or up to 10 pounds of force frequently) to medium work (exerting up to 50 pounds of forces occasionally, and/or up to 30 pounds of force frequently).


• Stooping-bending body downward and forward by bending spine at the waist.


• Reaching-extending hand(s) and arm(s) in any direction.


• Standing-particularly for sustained periods of time.


• Walking-moving about on foot to accomplish tasks, particularly for long distances or moving from one work site to another.


• Subject to Noise-sufficient noise to cause worker to shout in order to be heard above ambient noise level.


• Subject to proximity to moving mechanical parts, or exposure to chemicals.