QC Chemist II

MedPharm; Durham (NC); On-site; USD 65,000 - 85,000; Full time

Job summary

MedPharm is seeking a QC Chemist II to perform testing in a GMP environment within the Analytical QC team. The role requires experience in HPLC, FTIR, UV-Vis and other analytical methods, with emphasis on accurate data handling and documentation.

The candidate will support investigations for OOS/OOT, maintain notebooks, and revise methods as needed. B.S./M.S. in chemistry or related field with GMP exposure is preferred.

Qualifications

• B.S. with 4-6 years or M.S. with 3-4 years in chemistry, pharmaceutics or related field.
• Experience in GMP pharmaceutical environments.
• Proficiency with Good Documentation Practices (ALCOA++).

Responsibilities

• Perform testing using HPLC, GC, titrations and wet chemistry techniques.
• Carry out routine analytical experiments using established methods.
• Record data and draft reports for review.
• Assist in investigations for OOS/OOT and troubleshooting.

Skills

Empower

MS Excel

MS Word

Detail-oriented

GMP experience

Education

Bachelor's or Master in Chemistry or related

Tools

HPLC

FTIR

UV-Vis

Titration Equipment

Particle Size

Job description

Position Summary – The QC Chemist II position performs testing using a variety of analytical techniques. The successful candidate ensures that Testing and Documentation is compliant with GMP regulations and internal procedures. The position will be operating within a GMP environment for an Analytical QC team in a CDMO.

Essential Functions

• Well versed with various laboratory techniques, including, but not limited to HPLC, GC, titrations, and various wet chemistry techniques.
• Carry out routine laboratory work as directed by management and/or senior laboratory personnel with minimal supervision
• Performs complex analyses with moderate supervision.
• Conduct routine analytical experiments using established analytical methods and procedures.
• Data entry into reports, as directed by senior laboratory personnel.
• Verify simple transcription processes, such as checking accuracy of calculations and reviewing daily equipment verifications for compliance.
• Support testing for investigations for OOS, OOT, and aberrant results and troubleshooting.
• Review and maintain laboratory notebooks.
• Ensure data collected is processed and submitted for review in a timely manner.
• Aid in investigations for OOS, OOT, and aberrant results and troubleshooting by assisting in root cause determination and report writing.
• Maintains laboratory inventory of chemicals, standards, and consumables and orders materials as necessary.
• Revises existing methods, SOPs, and Work Instructions as needed.

Supervisory responsibilities

• Direct Reports: None
• Indirect Reports: None

Key Relationships

• Manufacturing Operations
• Analytical R&D
• Quality Assurance

Travel requirements

• N/A

Education and Experience

• B.S with 4-6 years' experience, or M.S with 3-4 years of experience: focus in chemistry, pharmaceutics or related scientific discipline
• 2-5 years´ experience in a GMP laboratory setting in the pharmaceutical industry
• Must have experience with general laboratory instruments, such as FTIR, Particle Size, Titration Equipment, and UV-Vis
• Must have experience in HPLC testing and troubleshooting
• Must have prior experience with raw materials or finished products testing in a GMP pharmaceutical environment.
• Must be well versed with Good Documentation Practices and ALCOA++ principles.
• Technical report writing proficiency preferred

Knowledge, Skills, and Abilities

• Proficiency in Empower, MS Excel, and MS Word
• Speaks, writes, listens and presents information in a logical and articulate manner appropriate for the audience
• Thorough when performing work, conscientious about attending to detail, and uses logical thinking that is well-organized and methodical and has a right first-time mentality

Physical Demands and Work Environment

• Requires constant standing, walking, seeing, gripping, & hearing
• Requires frequent sitting, bending, pushing, & reaching
• Requires occasional carrying under 20 LBS.
• Requires frequent lifting & pulling under 20 LBS, occasionally 20 – 60 LBS.
• Requires occasional twisting

You may be asked to take on any other responsibilities or tasks that are within your skills and abilities whenever reasonably asked.

Limitations and Disclaimer

The above job description is meant to describe the general nature and level of work being performed; it is not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required for the position. The Company is committed to making reasonable adjustments to the workplace to ensure the role is accessible to all candidates, including those with disabilities. To perform the job successfully, the employee must possess the abilities or aptitudes to perform each duty proficiently.