Principal Associate
Healthcare
PrincipalAssociateQA
“Principal Associate - QA at Principal Associate. Skills: Quality Systems, cGMP compliance, Pharmaceutical manufacturing. Ensure execution of Quality Systems. Sustain cGMP compliance”
Industry & Context.
Ability to gather, edit, organize, and summarize information; good judgement in making decisions
Onsite presence the majority of the time
What They're Looking For.
Must Have
Bachelor of Science degree in STEM related field, or equivalent experience, Minimum 3-5 years of experience in pharmaceutical manufacturing
Nice to Have
CT packaging experience, knowledge of cGMPs, Quality Systems, FDA Regulations, SAP Power user experience, Standard Operating Procedure writer experience, Ability to work across functional areas with people of all levels of the organization, oral and written communication skills, Demonstrated interpersonal and networking skills, Ability to gather, edit, organize, and summarize information from multiple sources including databases, websites, site interviews and audits, Ability to influence team interactions and lead initiatives, Must exhibit attention to detail, Ability to work under time pressure with proven demonstration of good judgement in making decisions under minimal supervision, Excellent teamwork skills
What You'll Do.
Ensure execution of Quality Systems
Sustain cGMP compliance
Ensure document control
Ensure data integrity
Review/approve/release batch records
Create/verify Certificates of Analysis
Provide quality support
Investigate deviations
Review/approve change controls
Review/approve protocols
Review/approve master label proofs
Review/approve dating
Provide Quality oversight
Assist with regulatory audits
Assist with site self-inspections
Provide guidance to counterparts
How You'll Work.
Team & Collaboration
Work across functional areas with people of all levels of the organization; Influence team interactions
Communication Scope
oral and written communication skills
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