QC Chemist II

MedPharm; North Carolina; On-site; USD 70,000 - 90,000; Full time

Job summary

MedPharm in North Carolina seeks a QC Chemist II to join our GMP Analytical QC team within a CDMO. You will perform testing with HPLC, GC and other techniques while ensuring documentation complies with GMP and internal procedures; data is submitted promptly for review.

Ideal candidates hold a BS/MS in chemistry and 2–5 years of GMP pharma lab experience, with proficiency in Empower, Excel and Word, and strong attention to detail. On-site role emphasizing method improvements and investigations.

Qualifications

• BS with 4–6 years or MS with 3–4 years of experience in chemistry or related discipline.
• 2–5 years of GMP laboratory experience in the pharmaceutical industry.
• Experience with HPLC testing and troubleshooting.
• Proficiency with Good Documentation Practices and ALCOA++ principles.
• Proficiency with Empower, MS Excel and MS Word.

Responsibilities

• Perform testing using analytical techniques (HPLC, GC, titrations, and wet chemistry) in a GMP environment.
• Document and review results, maintain laboratory notebooks and data integrity.
• Support investigations for OOS/OOT and aberrant results; assist in root-cause determination and reporting.
• Review and revise methods, SOPs and work instructions; ensure timely data submission.
• Maintain lab inventory of chemicals, standards and consumables; order materials as needed.

Skills

Analytical Chemistry

Documentation

Team collaboration

Education

BS in Chemistry

MS in Chemistry

Tools

HPLC

FTIR

Particle Size

Titration Equipment

UV-Vis

Empower

MS Excel

MS Word

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

While performing the duties of this job, there may be certain physical demands required for the position.

• 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

Other Duties

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.