BioPharma Consulting JAD Group
The Quality Control Operations (QCO) Analyst II Contractor plays a key role in ensuring the highest standards of quality and compliance across development, manufacturing, and commercialization activities. This position performs routine and non‑routine testing, supports method transfers and validation activities, contributes to investigations and data trending, and assists with daily laboratory operations. The role is essential in driving QC efficiency, accuracy, and continuous improvement.
Key Responsibilities
Perform routine and non‑routine analytical (HPLC/UPLC) and/or microbiological assays for raw materials, in‑process samples, product release, and stability studies in accordance with SOPs
Support weekend laboratory operations and maintain up‑to‑date training records
Assist with laboratory equipment maintenance, inventory management, reagent preparation, and sample handling
Review analytical data in a timely manner and serve as a qualified data reviewer
Execute operational assignments including raw material processes, environmental monitoring, and in‑process testing
Contribute to the revision and creation of controlled documents such as SOPs, work instructions, and test methods
Adhere to internal policies, SOPs, and regulatory requirements including GMP, GLP, and ICH guidelines
Participate in continuous improvement initiatives and collaborate cross‑functionally to enhance QC operations
Support regulatory submissions, inspection readiness activities, and internal/external audits
Requirements
B.S. in Chemistry, Biology, Biochemistry, or a related scientific discipline
4-8 years of pharmaceutical or biotech experience in a GMP QC environment or equivalent
Experience with method transfer and implementation; familiarity with method lifecycle management is preferred
Strong technical writing, data analysis, problem‑solving, and organizational skills
Excellent communication skills and ability to work effectively in a team‑oriented environment
Proficiency with LabWare LIMS, Microsoft Excel, Word, and PowerPoint preferred
Benefits
Weekend Shift Role
10‑month contract with possible extension
#J-18808-Ljbffr
Key Responsibilities
Perform routine and non‑routine analytical (HPLC/UPLC) and/or microbiological assays for raw materials, in‑process samples, product release, and stability studies in accordance with SOPs
Support weekend laboratory operations and maintain up‑to‑date training records
Assist with laboratory equipment maintenance, inventory management, reagent preparation, and sample handling
Review analytical data in a timely manner and serve as a qualified data reviewer
Execute operational assignments including raw material processes, environmental monitoring, and in‑process testing
Contribute to the revision and creation of controlled documents such as SOPs, work instructions, and test methods
Adhere to internal policies, SOPs, and regulatory requirements including GMP, GLP, and ICH guidelines
Participate in continuous improvement initiatives and collaborate cross‑functionally to enhance QC operations
Support regulatory submissions, inspection readiness activities, and internal/external audits
Requirements
B.S. in Chemistry, Biology, Biochemistry, or a related scientific discipline
4-8 years of pharmaceutical or biotech experience in a GMP QC environment or equivalent
Experience with method transfer and implementation; familiarity with method lifecycle management is preferred
Strong technical writing, data analysis, problem‑solving, and organizational skills
Excellent communication skills and ability to work effectively in a team‑oriented environment
Proficiency with LabWare LIMS, Microsoft Excel, Word, and PowerPoint preferred
Benefits
Weekend Shift Role
10‑month contract with possible extension
#J-18808-Ljbffr