GMP Quality Specialist — 1st Shift

Sharp Services, LLC; Macungie (Lehigh County); On-site; USD 70,000 - 95,000; Full time

Benefits offered by this job

Health benefits

Job summary

Sharp Services, LLC is seeking a Quality Specialist to provide quality oversight, GMP guidance and support, and make quality-related decisions for designated functional areas within Sharp Commercial sites. The role collaborates with internal teams daily and may represent Quality in customer interactions, driving GMP initiatives and continuous improvement through data analysis and coaching.

Qualifications include a Bachelor's in science with 1–3 years in pharmaceutical or related inspection

Qualifications

• Bachelor's degree in science is preferred with 1–3 years related experience.
• Experience inspecting Pharmaceutical or related industry is required.
• Professional quality certifications (ASQ, CQIA, CQI, CQT, Lean Six Sigma) are highly desired.

Responsibilities

• Participate in non-conformance investigations with root-cause analysis and CAPA planning.
• Review and approve quality documentation such as forms and work instructions.
• Execute QMS actions related to change controls, non-conformance, complaints and CAPAs.
• Support customer relationships related to Quality as needed.
• Identify risks and drive continuous improvement with operations.

Skills

Quality assurance

GMP knowledge

FDA regulations

Analytical skills

Education

Bachelor's degree in science

Tools

MS Office

QMS software

Data analysis

Job description

Sharp Services, LLC is seeking a Quality Specialist to provide quality oversight, GMP guidance and support, and make quality-related decisions for designated functional areas within Sharp Commercial sites. The role collaborates with internal teams daily and may represent Quality in customer interactions, driving GMP initiatives and continuous improvement through data analysis and coaching.

Qualifications include a Bachelor's in science with 1–3 years in pharmaceutical or related inspection