Sr QC Chemist

Sr QC Chemist

*** Relocation offered - Shift: 8-5/8:30-5:30 M-F ***

Occasionally weekend work required (delay in production, in-process sample coming – rare)

2 facilities, 10 minutes apart

MUST HAVE:

• Bachelor’s degree in Chemistry, Biochemistry, or related scientific discipline (Master’s or Ph.D. preferred).
• Minimum of 7 years of experience with a bachelor’s degree, 5 years with a master’s degree or 1 year with a PhD in a QC laboratory within the pharmaceutical, biotechnology, or chemical industry, with at least 3 years in a leadership role.
• Strong knowledge of analytical techniques such as GC, HPLC, KF, FTIR, water content, UV-Vis, titration, wet chemistry, analytical balances, and pH meters,
• Know how to validate or qualify pharmaceutical test measures (Med device) – test or chemical radiance (small molecules)
• Expedience from large molecules and validation
• Tested drug products for API
• Experience writing reports & SOPs
• Testing and validating at the same time
• GMP experience

Description

We are seeking a highly skilled and experienced Quality Control Chemistry Manager to lead and oversee the QC Chemistry team. This role is responsible for ensuring the integrity, accuracy, and compliance of all chemical testing activities in support of manufacturing and product release. The ideal candidate will bring strong leadership, technical expertise, and a deep understanding of cGMP regulations within a pharmaceutical or life sciences environment.

Independent execution of various standard laboratory techniques, including but not limited to HPLC, LC/MS, GC, GC/MS, FTIR, KF, LOD, and appearance assessment

Independent preparation of samples, solutions, instrument set-up and breakdown

Lead the transfer of analytical methods to QC from internal and external sources

Analysis of various sample types with approved prescribed test methods

Provide guidance and support on day-to-day tasks to QC personnel

Represent the Quality Control Department on internal and external matters as requested by QC Manager

Independent authoring, reviewing, and execution of analytical method validation protocols

Lead internal meetings as requested

Independent authoring, reviewing, and execution of stability study protocols

Independent preparation of data packets, stability reports, and certificates of analysis to summarize analytical testing

Participation in, or lead, Out of Specification investigations and the documentation of analytical deviations along with qualified investigators and management

A working knowledge of QC laboratory operating under US FDA/EU GMPs

Provide mentorship to co-workers as needed.

Skills

Quality control, Hplc, Gmp, pharmaceutical, gc-ms, gcms, lc-ms

Experience Level

Intermediate Level