Qa Associate I - Operations

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Job Summary

The Quality Associate I - Operations is the first of two levels within the QA Associate job family The associate I provides real-time QA support on the floor for GMP Manufacturing of drug product. The work scope includes floor oversight of manufacturing including observing critical processes and performing AQL visual inspection, executed GMP documentation review and supporting other 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 drug products.

Job Duties

• Review executed Manufacturing Batch Records and supporting documentation for completeness, accuracy and compliance
• Perform Acceptable Quality Limit (AQL) visual inspection of drug product
• Participate in site quality and process improvement initiatives. Represent QA on project teams and represent QA perspective as necessary
• Perform audits of manufacturing and support areas, including in-process batch record review for adherence to internal procedures and Good Documentation Practices
• Support the evaluation and lot disposition of intermediates, finish bulk drug substance and drug product
• Act as QA reviewer for deviations and CAPA issuance; with limited approval authority as designated by QA Management
• Act as first responder for on the floor quality issues in a timely manner, documentation of all events/investigations and required immediate corrective actions
• Guide personnel indirectly and directly involved in GMP operations pertaining to cGMP compliance, internal procedures, regulatory requirements and industry best practices
• May participate in root cause analysis using methodologies, such as: fishbone, 5 whys, etc.
• Perform QA On-the-Floor activities supporting client projects, including room release, auditing critical processes, reviewing documentation in real time, and resolving issues that occur during manufacturing
• Participate in SOP revision as it pertains to process improvements

Professional Skills –

• Strong organizational skills and attention to detail
• Demonstrated positive interpersonal skills and the ability to communicate well orally and in writing
• Ability to make risk based decisions and resolve issues with minimal guidance
• Proficiency in MS Office including Word, and Excel

Experience

• Knowledge and ability to apply basic scientific principles to solve operational, as well as routine quality tasks
• Knowledge of FDA regulations (i.e., 21CFR Part 210, 211 & 820) and some experience working with international regulations such as ICH
• Knowledge and exposure to using Risk Management Tools (FMEA, HACCP, PHA, etc.) and familiarity with ICH Q9 preferred
• Exposure to lean operation excellence highly desirable
• Exposure to RCA, technical writing, and working with quality related investigations

EDUCATION

• Bachelor’s Degree in a relevant scientific discipline preferred with a minimum of 0-2 years of pharmaceutical or biotech industry experience with 1+ years of experience in a QA Operations role supporting late stage clinical and/or commercial production preferred
• ASQ certification preferred

QUALITIES

• Able to work with some limited supervision, able to escalate issues as needed
• Ability to work in a dynamic, fast paced work environment
• Honesty, integrity, respect and courtesy with all colleagues
• Is flexible and adaptable through operational and organizational change

Physical Requirements & Mental Demands

• Frequent reading, writing, and verbal communication
• Demonstrated capacity to work on multiple projects (duties) simultaneously
• Must be able to travel between multiple local production facilities
• Able to translate ideas to actual concepts and processes

COMMUNICATIONS & CONTACTS

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

Managerial & Supervisory Responsibilities

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

TRAVEL

• < 10%

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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.