QA Specialist II - API Batch Release & Compliance

Initial Therapeutics, Inc.; Clayton (NC); On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

Annual bonus

14 holidays

Health insurance

Dental insurance

Vision insurance

401K match

Parental leave

Family medical leave

Tuition assistance

Life insurance

Disability insurance

Referral program

Job summary

Novo Nordisk in Clayton, NC is seeking a QA professional to perform batch review activities, review API/Intermediate documentation in LIMs, SAP, and NovoGlow, and ensure compliance with cGMP manufacturing standards.

You will review and approve minor change controls and deviations, guide departments on quality activities, participate in root-cause analysis, and provide on-floor production support and quality oversight.

Qualifications

• Bachelor's Degree in Life Sciences, Engineering, or related field
• Minimum of three (3) years of QA or related experience in the pharmaceutical or medical device industry preferred
• Understanding of cGMP manufacturing & production processes & how to apply required
• Understanding of the Batch review Processes preferred
• Understanding of quality management systems preferred
• Understanding of quality oversight & on floor production support preferred
• Strong written & verbal communication skills required
• Strong computer skills in MS Office, PowerPoint, Word, Excel, etc required
• Understanding of cGMPs in pharmaceutical manufacturing required
• Understanding of Quality & Production processes required
• Good stakeholder relations required
• Capable of prioritizing & managing workload required

Responsibilities

• Perform Batch review activities
• Review API/Intermediate Batch documentation in LIMs, SAP, NovoGlow
• Ensure site compliance with Regulations, ISO standards, & Corporate/Local SOPs
• Review & approve minor change control requests & low complex major change controls
• Review & approve minor deviations & low complexity major deviations
• Provide guidance to departments regarding quality & related activities
• Participate & provide input to root-cause analysis
• Participate in process confirmations & quality oversight
• Authorized person according to Novo Nordisk Quality Manual
• Other accountabilities, as assigned

Skills

QA experience

cGMP knowledge

On-floor support

Root cause analysis

Communication skills

MS Office

Education

Bachelor's degree in Life Sciences/Engineering

Tools

LIMS

SAP

NovoGlow

Job description

Novo Nordisk in Clayton, NC is seeking a QA professional to perform batch review activities, review API/Intermediate documentation in LIMs, SAP, and NovoGlow, and ensure compliance with cGMP manufacturing standards.

You will review and approve minor change controls and deviations, guide departments on quality activities, participate in root-cause analysis, and provide on-floor production support and quality oversight.