QC STABILITY SPECIALIST

QUALIFICATIONS:

• Required:
• Bachelor’s degree in a scientific field with 3 or more years’ experience in a CGMP / laboratory environment.
• 3+ years of relevant experience in a cGMP organization
• 2+ years stability program experience
• Experience working in a cGMP/ laboratory required.
• Experience working in a (CMO) contract manufacturing/development organization preferred.
• Ability to work independently with minimal supervision and in compliance with cGMPs.
• Scientific technical writing ability including authoring and revising SOPs or technical documents and reports.
• Must have strong attention to detail as well as ability to work in a cross-functional team environment
• Excellent organizational skills and the ability to work within a fast-paced environment
• Must have proven logic and decision-making abilities, critical thinking skills.
• Working knowledge of cGMP, ICH, USP, and global compendial regulations guidelines specifically how they pertain to stability programs.
• Proficient in Microsoft Office, Excel, and PowerPoint.
• Excellent communication and interpersonal skills are must.
• Proficiency in standard QC laboratory equipment (HPLC, GC, FTIR, UV, KF, etc.) desirable
• Background in data trending desirable
• Excellent interpersonal skills and the ability to communicate well both orally and in in writing
• Ability to multi-task in a dynamic environment with changing priorities
• Resilient, can quickly move forward despite challenges
• A drive to achieve results for self and clients
• Positive attitude and strong team, cross team collaboration
• Honesty, integrity, respect and courtesy with leadership and peers
• #LI-RS1
• 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.

Bachelor’s degree in a scientific field with 3 or more years’ experience in a CGMP / laboratory environment.