QA Operations Specialist I - Medical Device Floor Support

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.

The QA Operations Specialist I - Medical Device Floor Support is responsible for providing QA support of Manufacturing and Visual Inspection activities for clinical and commercial medical device products in a GMP facility. The work scope includes on-the-floor Quality oversight of manufacturing activities including observing formulation and fill processes, GMP documentation and Batch Record review, line clearance, disposition of incoming raw materials, review and approval of facility work orders, and other various QA functions as needed. Real time continuous monitoring of manufacturing related systems and processes to ensure compliance with applicable regulatory and industry standards, needed quality improvements, and safety/efficacy for phase appropriate GMP manufacture of Medical device products.

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.

• Perform QA on-the-floor activities supporting client projects, including room release, auditing critical processes, reviewing GMP documentation in real time.
• Perform periodic walkthroughs of manufacturing and support areas to ensure adherence to policies and procedures.
• Batch record review for adherence to internal procedures and Good Documentation Practices
• Review, approval and disposition of incoming materials such as consumables, excipients, and bulk device Ingredient, as applicable.
• QA review and approval of new and revised GMP documents such as SOP's and raw material specifications.
• Act as first responder for on the floor quality issues in a timely manner, documentation of all events/investigations and required immediate corrective actions.
• Assist in nonconforming material investigations.
• Review of Quality Control Environmental Data
• Review and approval of work orders impacting manufacturing facilities and utilities
• May participate in root cause analysis using methodologies, such as: fishbone, 5 whys, etc.
• Advise and coach internal customers on proper documentation of tasks
• Assist in the initiation of Quality Systems (deviations, CAPA, Nonconformances).
• Support Visual Inspection, packaging, and labeling operations
• Create, review, and approve final product labels
• Participate in SOP revision as it pertains to process improvements.
• Participate in site quality and process improvement initiatives. Represent QA on project teams and represent QA perspective as necessary.
• Guide personnel indirectly and directly involved in GMP operations pertaining to cGMP compliance, internal procedures, regulatory requirements and industry best practices

Special Demands: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. The employee must be physically capable to perform the duties listed below with or without reasonable accommodations which may be made to enable individuals with disabilities to perform the essential functions.

* Ability to work in a dynamic, fast-paced work environment

* Honesty, integrity, respect, and courtesy with all colleagues

* Creative with the ability to work with minimal supervision and balance with independent thinking

* Resilient through operational and organizational change

* Exceptional organizational skills and attention to detail

* Ability to make risk-based decisions and resolve issues with minimal guidance

* Excellent interpersonal skills and the ability to communicate well orally and in writing

* Proficiency in MS Office including Word, and Excel

* Excellent verbal and written communication skills required

Work Environment: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

* Ability to don Device gowning requirements

* Frequent reading, writing, and verbal communication

* Must be able to travel between multiple local production facilities

* Able to translate ideas to actual concepts and processes

* Proven ability to manage multiple projects (duties) simultaneously

* Able to work in a highly complex environment with competing demands and priorities

* Cross functional staff, members of management, internal and external clients, members of the Quality organization

* No managerial responsibilities. This is an individual contributor role.

* < 10% Travel

#LI-LL1

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.