QC Specialist II, Analytical Investigations

Reposted 13 Days Ago
Be an Early Applicant
Bedford, NH, USA
In-Office
Mid level
Pharmaceutical
The Role
As a QC Specialist II, you will lead investigations, manage analytical testing, draft technical documents, and ensure compliance in a GMP environment.
Summary Generated by Built In

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.


We are PCI. 


Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.

   

What You’ll Do

As a QC Specialist, you will:

  • Lead investigations into QC Analytical deviations, OOS/OOT/OOE results, and other quality issues.

  • Serve as a key point of contact during audits and inspections, ensuring timely and compliant responses.

  • Draft and revise change controls, technical reports, cGMP documents, and protocols.

  • Perform QC analytical testing, review data, and identify trends to proactively address risks.

  • Assist in managing analytical equipment to maintain compliance and efficiency.

  • Collaborate cross-functionally to close out quality events and audit findings on time.

  • Help shape and refine QC processes that support continuous improvement.

What You Bring

  • Education/Experience: Bachelor’s degree in Analytical Chemistry, Chemistry, Pharmaceutical Sciences, or related field; 2–5 years of QC Analytical Chemistry experience (pharma experience preferred).

  • Technical Skills: Hands-on experience with UPLC, HPLC, GC, FTIR, UV/VIS, Karl Fisher, Particle Size Analyzer, Densitometer, and Osmometer.

  • Knowledge: Solid understanding of cGMP, ICH, USP, and global compendia guidelines, especially in analytical method validation and stability studies.

  • Strengths: Strong organizational and documentation skills, technical writing ability, and excellent communication skills (written and verbal).

  • Mindset: Ability to thrive in a fast-paced, dynamic environment, juggling multiple priorities while maintaining a sharp eye for detail.

  • Tech: Proficiency in MS Office; experience with lab-based data management systems a plus.

Why Join Us

  • Be part of a collaborative team where your expertise directly impacts patient safety and product quality.

  • Gain exposure to diverse analytical techniques and regulatory processes.

  • Opportunity to work in a GMP environment supporting both clinical and commercial product lifecycles.

  • Professional growth through hands-on problem solving, cross-functional collaboration, and continuous learning.

#LI-LL1

Join us and be part of building the bridge between life changing therapies and patients. Let’s talk future

Equal Employment Opportunity (EEO) Statement:
PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.

At PCI, Equity and Inclusion are at the core of our company’s purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity – at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.

Skills Required

  • Bachelor's degree in Analytical Chemistry, Chemistry, Pharmaceutical Sciences, or related field
  • 2-5 years of QC Analytical Chemistry experience (pharma experience preferred)
  • Hands-on experience with UPLC, HPLC, GC, FTIR, UV/VIS, Karl Fisher, Particle Size Analyzer, Densitometer, and Osmometer
  • Solid understanding of cGMP, ICH, USP, and global compendia guidelines
  • Strong organizational and documentation skills, technical writing ability, and excellent communication skills
  • Proficiency in MS Office; experience with lab-based data management systems a plus

PCI Pharma Services Compensation & Benefits Highlights

The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about PCI Pharma Services and has not been reviewed or approved by PCI Pharma Services.

  • Retirement Support Feedback suggests the company provides a 401(k) with an employer match in the mid‑single‑digit range, with immediate vesting noted in certain cases. This is viewed as a solid component of the overall package.
  • Leave & Time Off Breadth PTO and paid holidays are commonly available, and some roles indicate vacation is accessible from early tenure. Availability of time off is frequently described as a positive element of the package.
  • Affordable Benefits Health insurance is sometimes described as reasonably priced depending on plan tier. Feedback suggests core medical, dental, and vision coverage is part of a standard offering.

PCI Pharma Services Insights

Am I A Good Fit?
beta
Get Personalized Job Insights.
Our AI-powered fit analysis compares your resume with a job listing so you know if your skills & experience align.

The Company
HQ: Philadelphia, PA
2,259 Employees

What We Do

PCI is a leading provider of integrated pharmaceutical development services to the global healthcare market. With facilities in North America and Europe, PCI supports pharmaceutical and biotech companies with products destined for more than 100 countries around the world. PCI provides services for each stage of the product lifecycle – from early Phase I through commercial launch and long-term supply – and partners with customers to provide key insight and expertise in enabling successful commercialization and bringing lifesaving medications to patients. For more information, go to www.pci.com.

Similar Jobs

Zscaler Logo Zscaler

Program Manager

Cloud • Information Technology • Security • Software • Cybersecurity
Easy Apply
Remote or Hybrid
USA
8697 Employees
127K-182K Annually

Silverfort Logo Silverfort

Regional Sales Manager

Information Technology • Sales • Security • Cybersecurity • Automation
Remote or Hybrid
United States
507 Employees

Silverfort Logo Silverfort

Senior Sales Engineer

Information Technology • Sales • Security • Cybersecurity • Automation
Remote or Hybrid
United States
507 Employees

Silverfort Logo Silverfort

Account Manager

Information Technology • Sales • Security • Cybersecurity • Automation
Remote or Hybrid
United States
507 Employees

Similar Companies Hiring

Formation Bio Thumbnail
Artificial Intelligence • Big Data • Healthtech • Biotech • Pharmaceutical
New York, NY
150 Employees
Pfizer Thumbnail
Artificial Intelligence • Healthtech • Machine Learning • Natural Language Processing • Biotech • Pharmaceutical
New York, NY
121990 Employees
Cencora Thumbnail
Healthtech • Logistics • Pharmaceutical
Conshohocken, PA
51000 Employees

Sign up now Access later

Create Free Account

Please log in or sign up to report this job.

Create Free Account