QA Specialist II - Doc Control

QUALIFICATIONS:

• Required:
• High School Diploma; and at least 10 years of industry experience with a minimum of 6 years document control experience in the Biotech, Pharmaceutical or Medical Device industries is required.
• Previous Document Control and/or eQMS configuration and system management experience required.
• Advanced knowledge of cGMPs, EU regulatory requirements, and FDA 21 CFR Parts 210,211 and 820 and Industry best practices required.
• Working knowledge of Computer System Validation and Change Control requirements.
• Assist is leading large or cross-functional projects and improvement initiatives as assigned.
• Preferred:
• Superior professional communication skills across all levels of the organization written and verbally
• Superior customer service.
• Identify and lead large or cross-functional projects and improvement initiatives.
• May support more than one production facility.
• Expert skill level in MS Office, general computer uses and the electronic Quality Management System and associated tools.
• Excellent professional written and verbal skills. Team oriented.
• Excellent Organizational skills. Highly Efficient.
• Excellent attention to detail.
• Perform repetitive tasks with high level of detail, requiring decision making on daily tasks and improvement initiatives. Sound decision making ability required. Recommend solutions to Management for critical decisions.
• #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.