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Quality Assurance Chemist I
2 months ago
The Quality Control Scientist I is responsible for executing routine analyses and documentation of various samples, including In-Process and Finished Product samples for pharmaceutical batch Release, Stability samples, or Projects within the QC Chemistry Laboratory, adhering to established standards.
This role supports internal development and manufacturing operations, ensuring detailed observations are made, and test results are documented and communicated effectively.
KEY RESPONSIBILITIES:
- Conduct routine chemical testing of finished products and stability samples using both internally developed and compendial test methods.
- Execute validated test methods for pharmaceutical finished products to assess strength, impurities, identity, and characteristics through HPLC and wet chemistry techniques.
- Identify and report any out-of-specification or unexpected results and address non-routine analytical and product issues promptly.
- Perform daily instrument calibrations and verifications as required.
- Accurately document testing and analysis results, ensuring clear communication of findings.
- Prepare test solutions, including diluents and mobile phases, while maintaining a clean and organized work area and instrumentation.
- Adhere strictly to Standard Operating Procedures, Good Manufacturing Practices, Good Laboratory Practices, and Safety guidelines.
- Maintain compliance with company and facility standards.
REQUIRED QUALIFICATIONS:
- 1-2 years of experience in chemical testing with chromatographic techniques is preferred.
- Proficient theoretical knowledge of HPLC is required, along with practical application skills.
- Equivalent combinations of education, training, and relevant work experience may be considered.
- Strong understanding of basic instrumental technologies and qualitative and quantitative chemical analyses.
- Familiarity with quality and regulatory requirements in the pharmaceutical sector.
- Effective problem-solving skills and a logical approach to scientific challenges.
- Commitment to following all company policies, SOPs, cGMPs, work instructions, methods, and analyst guidelines.
- Ability to multitask and manage time efficiently to meet workload demands.
- Proactive in seeking additional assignments upon completion of primary responsibilities.
- Demonstrated initiative in pursuing training and learning opportunities to enhance personal skills and share knowledge with team members.
- Strong interpersonal and communication skills, both oral and written.
- Capability to apply mathematical operations for tasks such as test reliability determination, variance analysis, and correlation techniques.
- Able to thrive in a fast-paced work environment.
PHYSICAL REQUIREMENTS:
This position requires ordinary ambulatory skills and physical coordination sufficient to navigate office locations; ability to stand, walk, stoop, kneel, and crouch for extended periods; manipulation of light to medium weights (10-35 pounds); dexterity in hands and fingers for prolonged typing and grasping; visual acuity for using a keyboard, computer monitor, and reading materials; and the ability to sit, reach, talk, and hear for extended durations.
SAFETY EQUIPMENT:
- Safety glasses
- Safety shoes
- Lab coat
- Latex or similar gloves
- Safety apron
- Organic respirator (occasionally)
EDUCATION:
Accredited Bachelor's degree or higher in a physical science, preferably in Chemistry.
WORK SCHEDULE:
Full-Time; Monday to Friday.