Qc Stability Specialist

PCI Pharma Services • Bedford, NH

7d • Onsite

About The Position

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.

This position has primary responsibility for facilitation of PCI PHARMA SERVICES’s stability program including authoring stability protocols, set-down of samples, removal of samples from storage according to schedules, coordination of testing with internal/external laboratories, and collation of data for QA review. Also supporting activities related to the on-time completion of testing for QC stability samples as required per the applicable stability programs. Additional areas of responsibility include but are not limited to QC data review / trending and generation or reports.

Requirements

• 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.
• 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.

Nice To Haves

• Experience working in a (CMO) contract manufacturing/development organization preferred.
• 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

Responsibilities

• Coordinate daily activities for the QC analysts and other departments performing stability workflows, ensuring all activities are completed as required per the stability testing program.
• Using influence strategies to drive testing completion without direct authority over testing groups.
• Support laboratory investigations and deviations, identifying root causes and enacting effective CAPAs to improve overall laboratory performance (%RFT).
• Interact with clients both internal and external providing status updates.
• Provide support in resolving technical QC issues.
• Perform technical data review, data analysis, and trending.
• Author(s) and Revise(s) technical documentation (e.g. Stability Reports, SOPs, forms, etc.) as required.
• Implement and applies cGMP concepts in association with department specific responsibilities.
• Actively engage in continuous improvement for areas of responsibility, collaborating with other departments to identify and implement process efficiencies and workflows.
• Drive testing efficiencies in order to reduced testing time and improve compliance.
• Conflict resolution, problem solving in a cross functional setting, and ability to meet testing timelines.
• Occasional and infrequent testing support with advanced analysis and wet/physical chemistry.
• Supports audits, including laboratory walkthroughs with client and regulatory agencies.
• Other duties, as needed

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level