QC Specialist II, Analytical Investigations
Company: PCI Pharma Services
Location: Bedford
Posted on: April 2, 2026
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Job Description:
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.
Keywords: PCI Pharma Services, Haverhill , QC Specialist II, Analytical Investigations, Science, Research & Development , Bedford, Massachusetts
