New · posted Oct 15
Celldex Therapeutics · Biotechnology
Quality Assurance Associate II
- Fall River, MA
- On-site
- Full-time
- Associate & Specialist
Closes Sep 3, 2027 · 323 days left
The role
The Quality Assurance Associate II performs documentation activities associated with manufacturing operations while ensuring compliance with GXP quality systems.
What you need
- Associate Degree with 2+ years GMP experience or 4+ years GMP experience without a degree
- Document Management experience in GMP environment preferred
- Broad knowledge of GMP and other GxP quality systems, policies, and regulations
- Strong communication and organizational skills
- Proficiency using MS Office Suite
- Proficiency using an EDMS
- The ability to multi-task and manage and prioritize workload in a proactive manner
- The ability to take initiative, maintain confidentiality, meet deadlines, and work independently and as part of a team
What you'll do
- Document Management
- Electronic Document Management System (EDMS) workflow coordinator for GMP documentation and other GxP documentation, as needed
- Document formatting and review
- Attachment issuance support, that includes, but is not limited to, issuing and reconciling Batch Records, Solution Records and Validation Testing documentation and maintaining tracking tools, both hard copy and electronic
- Assignment of raw material part numbers
- Support raw material and product release
- Label generation
- Maintenance of label and ribbon inventory and scheduling annual maintenance of labeling machines
- Write/revise QA SOPs and reports, as related to document control
- Maintain, scan and archive Quality Assurance documentation
- Report on Vendor Change Notifications to determine their effects, if any, on manufacturing
- Responsible for organizing and maintaining off-site storage shipments for Fall River
- Training Program Support
- Perform internal training, including, but not limited to, off-site storage preparation
- Maintain training documentation including the hard copies and the electronic training files in SharePoint, as needed
- Assist with the annual audit of training files
- Auditor
- Conduct annual documentation audits
- Support internal GMP audits
- Support external audit documentation requests
- Other related job functions and QA support as needed
Pay and benefits
$66,413 – $86,250 a year
Employer providedAnnual discretionary bonus
Long term incentive
401(k) with employer contribution
Health care and other insurance benefits
Paid holidays
Vacation and sick days
Where you'll work
Fall River, MAOn-siteOpen in Maps (opens in a new tab)
More jobs in Fall River, MAFrom the posting
About Celldex Therapeutics
About Celldex
Celldex is pioneering new horizons in immunology to deliver life-changing therapies. We are relentless in our pursuit of novel antibody-based treatments that engage the human immune system and directly affect critical pathways to improve the lives of patients with allergic, inflammatory and autoimmune disorders. We have built a culture where innovative and talented people thrive—focusing a significant effort on attracting and retaining passionate and motivated employees who want to play a role in helping people with serious health conditions and who see this effort as personally rewarding. In our highly entrepreneurial environment, employees are empowered and the opportunity for professional development occurs every day.
Equal opportunity, accessibility and legal noticesCelldex Therapeutics's statements, word for word
The expected base salary for this position is: $66413.00 to $86250.00. We are committed to compensating employees equitably based on several factors including experience, education, licensure/certifications, skill level, location of the position, and availability of similar talent in a competitive market. Subject to eligibility and applicable plan terms, compensation includes base salary, annual discretionary bonus, long term incentive, 401(K) plan with employer contribution, health care and other insurance benefits (for employee and family), paid holidays, vacation, and sick days. A summary of our benefits can be found on our careers page Celldex is proud to be an equal opportunity employer that strives to foster a culture of diversity, equity, and inclusion. We are committed to promoting a diverse environment through development, recruiting and community outreach.
Job intelligence
The context around this role
Live data · October 15, 2026
Salary intelligence
How the pay compares
This role's midpoint is 3% below the US median for Quality Assurance roles at this level.
This roleEmployer provided
Associate & Specialist roles in the US157 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $66,413 | — | $86,250 |
| All US (middle half) | $59,000 | $78,500 | $94,000 |
This role: Celldex Therapeutics's own published range. Comparisons: the base pay employers published on open Quality Assurance roles at the same level on Regulatory Jobs, October 15, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Quality Assurance
The general path across 845 open Quality Assurance roles on Regulatory Jobs, with the titles they carry most. Not Celldex Therapeutics's own promotion track.
Career resources on Quality Assurance
Skills DNA
What this role leans on
How many of the posting's 13 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- GMP and compliance7
- Documentation and SOPs5
- Collaboration and leadership3
- Quality systems and risk2
- Lab testing and methods1
- Validation and qualification1
- Regulatory submissions1
Regulatory intelligence
The rules behind this role
Frameworks and standards this posting's work falls under, matched from its own words, each linked to the official source.
From Regulatory News
Manufacturing and quality coverage for this professionCompany hiring pulse
Celldex Therapeutics on Regulatory Jobs
- 5
- Open roles
- 5
- Distinct roles
- 2
- Locations
By discipline
- Quality5 100%
By level
- Director2 40%
- Associate & Specialist2 40%
- Senior & Principal1 20%
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Quality Assurance Associate II at Celldex Therapeutics
Applications close September 3. $66K–$86K a year, employer provided.