Work Schedule

Second Shift (Afternoons)

Environmental Conditions

Office

Job Description

Provide Quality expertise and oversight of the batch disposition process which includes assessments of documentation to assure quality and compliance by site procedures and cGMPs.Responsible for assembling and or review of batch release documentation packages (BPR/LPR/COA/COC).Daily interaction with business management, planning, and technical services associates to assist with troubleshooting, documentation corrections/notes, and mentorship.Aids in identification of continuous improvement opportunities; Participates in practical process improvement initiatives.Education

Minimum requirement High School Diploma, preferably an Associates/Bachelor’s Degree in, Science, or applicable field.

Experience

Minimum 2 years’ experience in QC, QA, Analytical Development, Process Engineering, Engineering services or OSD Manufacturing

Experience in cGMP or pharmaceutical, medical device, or related manufacturing industry

Equivalent combinations of education, training, and meaningful work experience may be considered.

Knowledge, Skills, Abilities

Knowledge of FDA/EMA regulatory requirements applicable to biologics or pharmaceuticals.

Knowledge of Quality oversight of batch disposition.

Excellent organizational skills and analytical and problem-solving abilities.

Strong verbal and writing skills

Possesses exceptional time management and multi-tasking abilities to meet commitments.