SDO_Quality Assurance Specialist

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. Summary of Objective: The Quality Assurance Specialist will support investigation for clinical trail and packaging/labeling and distribution operations. The Quality Assurance Specialist will support PCI’s packaging/labeling and distribution operations. This full time position will report to the Quality Operations Director focusing on supporting the Quality department with inspection, product or material release, document control, production monitoring, tracking quality metrics and assisting with validations, preventative actions, audits, and continuous improvement. This position will report to the Quality Assurance Manager. Essential Duties and Responsibilities: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The essential duties and responsibilities include the following but other duties may be assigned. 1. Perform product lot disposition by reviewing executed packaging records for completeness, accuracy, and compliance to GMP and company procedures. 2. Perform document change control activities as needed. 3. Perform and lead in investigations, NCMRs and Complaints. 4. Track and monitor CAPAs. 5. Perform training as needed. 6. Support Distribution activities. 7. Collect quality metrics. 8. Support the Quality Operations Director with internal, supplier, regulatory and customer audits. 9. Perform QC line clearances, in-process checks and monitoring of labeling and packaging activities on the floor. 10. Perform QC inspection or release of incoming GMP materials according to appropriate material specifications 11. Ensure department and company goals are met. 12. May perform other department tasks. Qualifications: The requirements listed below are representative of the knowledge, skill, and/or ability required for the stated position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Required: High School Diploma and/or 3-5 years related experience and/or training. Basic Mathematical Skills Basic Computer Skills: Ability to perform basic computer tasks and has the ability to operate common computer programs. Minimum Professional Proficiency: Ability to speak in a way that allows one to participate effectively in various conversations. Ability to read various types of standard items addressed to general readers. High Reasoning: Ability to solve practical problems and deal with a variety of concrete variables in situations where there is only limited standardization. Ability to interpret a variety of instructions that may be provided in various forms. Preferred: 3+ years of experience in Quality Assurance within a cGMP-regulated environment. Knowledge of Six Sigma / A3 problem-solving methodologies. The hiring rate for this position is $70,304-$75,928 plus eligibility for an annual performance bonus. Final offer amounts are determined by multiple factors, including but not limited to specific and relevant experience, education, credentials, geography, and subject matter expertise. PCI offers full-time employees a competitive benefits package that includes paid time off, health insurance coverage (including dental and vision), a flexible spending account, and a 401(k) plan. #LI-SW1 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. Why work for PCI Pharma Services? At PCI, we have an uncompromising focus on providing quality and operational excellence and providing the industry leading customer experience. Our people make all of this happen, so providing an industry leading experience for our people is equally as important. By creating an authentic culture of purposeful work, we aspire to be an interesting and fulfilling place for talented individuals to grow careers. We live a philosophy of intentional learning combined with real-life experience supported by a fair and competitive rewards program. We are individuals, teams and a company that believes in our purpose and our approach is simple, the people who work at PCI fuel our business; we don’t say no, we figure out how.