Principal Associate

Healthcare

PrincipalAssociateQA

$65–169k Indianapolis, Indiana, United States FULL TIME Remote Friendly
The Brief

“Principal Associate - QA at Principal Associate. Skills: Quality Systems, cGMP compliance, Pharmaceutical manufacturing. Ensure execution of Quality Systems. Sustain cGMP compliance”

Industry & Context.

Healthcare
Problems you'll solve

Ability to gather, edit, organize, and summarize information; good judgement in making decisions

Eligibility Requirements

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

Free ATS check

Applying for this Principal Associate - QA role?

Most applicants get filtered before a human reads their resume. See if yours makes the cut.

How to Apply on Workday

  • Workday has a multi-step form — save your progress after every section.
  • "Apply With LinkedIn" can fail or lose data; manual entry is more reliable.
  • Watch for the "Submit for Review" final step — hitting "Save" alone does not submit.
  • Job requisition numbers are useful when following up with HR by email.

ANONYMOUS · UNFILTERED

What do employees actually say about Principal Associate?

Real rants from real employees. Read before you apply.

Read Company Rants →