[ref. g20355202] Scientist I, Quality Control

Overview:

This role includes responsibility of QC testing according to Standard Operating Procedures (SOPs) and current Good Manufacturing Practices (cGMP), managing or overseeing the work of more junior QC staff, setting up and maintaining systems for QC laboratory, assist with scheduling, reviewing of tests results, assist in the management of the QC laboratory, participation in assay transfer and validation activities.

This position is based in our Milton Park location and typically has a 5-day on-site expectation.

Responsibilities:

Key responsibilities:

• Perform QC testing following Standard Operating Procedures (SOPs).
• Assist with the maintenance of QC laboratory and equipment.
• Generate protocol and report for assay transfers/validation.
• Review and complete documentation in accordance with current Good Manufacturing Practices (cGMP).
• Author and review SOPs, forms, Deviations, Change controls CAPA, CoA (Certificate of Analysis) reports
• Lead or assist with OOS, OOT, and lab investigations as needed.
• Participate in regulatory inspections and submissions, as needed.
• Lead QC laboratory equipment introduction and participate in validation activities.
• Interact within internal as well as across other functional group to communicate QC requirements.
• Manage receipt and storage of QC samples, reagents and maintain retain inventory.
• Coordinate shipping of samples to Milton Park and contract testing laboratories.
• Training others within department for methods and processes according to GMP standards.
• Become SME/Trainer for method or process and lead troubleshooting or method optimization as required
• Line management responsibility for direct reports if applicable

• Manage technical studies performed with external companies.
• Represent QC at inter-departmental meetings and interact with external vendors, as necessary.

Qualifications:

Preferred Educational requirements:

• A BA or BS in Chemistry/Biochemistry/Microbiology or other related science.

Experience and skill requirement:

• 4 years or more GLP / GMP experience in a relevant work environment.
• Computer literacy (including MS Word and Excel)
• Ability to work well with others
• Effective communication skills
• Good organizational skills

Location:

• This position is based in our Milton Parklocation and typically has a 5-day on-site expectation.