QC Specialist II, Analytical Investigations

PCI Pharma Services; Tennessee; On-site; USD 65,000 - 90,000; Full time

Job summary

PCI Pharma Services is seeking a QC Specialist in Tennessee to lead investigations into analytical deviations and support audits, change controls, and method validation.

You will perform QC testing, review data for trends, and collaborate cross-functionally to close quality events while maintaining cGMP compliance. Strong documentation and communication skills are essential in a fast-paced environment.

This role offers growth in a GMP environment supporting both clinical and commercial lifecycles.

Qualifications

• 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 Fischer, Particle Size Analyzer, Densitometer, and Osmometer.
• Solid understanding of cGMP, ICH, USP, and global compendia guidelines, especially in analytical method validation and stability studies.
• Strong organizational and documentation skills, technical writing ability, and excellent communication skills (written and verbal).
• Ability to thrive in a fast-paced, dynamic environment, juggling multiple priorities while maintaining a sharp eye for detail.
• Proficiency in MS Office; experience with lab-based data management systems a plus.

Responsibilities

• 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.

Skills

Attention to detail

Technical writing

Communication

Education

Bachelor’s degree in Analytical Chemistry

Tools

UPLC

HPLC

GC

FTIR

UV/VIS

Karl Fischer

Particle Size Analyzer

Densitometer

Osmometer

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.

Join us and be part of building the bridge between life changing therapies and patients.

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.