QA Associate

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.

JOB SUMMARY

Responsible for applying and maintaining quality standards for PCI Pharma Services and products. Responsible for the maintenance and performance of all quality management systems. Works closely with production and customer service to ensure customer specifications are met and comply with internal operating standards and regulatory standards (GMPs). Reports to the Quality Director.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Consistently applies company SOP's relative to production, quality, and pharmaceutical standards
• Reviews and approves executed inspection and production-related documentation.
• Guides, coaches, and directs production staff with respect to Quality issues and concerns using collaborative problem-solving skills
• Compiles and maintains QA documentation and data
• Consistently evaluates PCI quality control methods, policies, etc. and makes recommendations for improvement
• Prepares Deviation/Incident Reports
• Investigates customer complaints and provides a detail report to client outlining results of investigation
• Reviews IORFs and determines type of documentation required to support the incident.
• Annual Product Assessments as required by clients.
• Responsible for monitoring and adhering to GMP as well as Health and Safety.
• Practices under the Occupational Health and Safety Act, raising concerns or issues to the Sr. QA Associate and/or Quality Director.
• Conducts training on PCI's Quality Management Systems, processes and performs annual GMP refresher training.
• Conducts environmental monitoring of Production Areas
• Investigates temperature and humidity excursions in GMP areas
• Performs weekly assessments of temperature and humidity reports
• Assists Quality Director with external audits.
• Assists with responses to external, internal, and Regulatory audit observations
• Undertakes quality control inspections, line clearances and line audits as required
• Approves material requisition forms for packaging, destruction, QA samples, rejects and any adjustments of pharmaceutical components and/or end use products
• Performs new product assessment to determine if new product (API) can be primary or secondary packaged at our site.
• Lead, measure, and assess the procedures associated with the initiation and reporting of deviations, complaints, self- inspections and CAPA's
• Initiate CAPA's resulting from deviations, customer complaints, identified non- conformances, audits, or any other means of problem identification
• Ensure resolution of corrective actions is accomplished in a timely manner using sound methods for root cause analysis, short term containment, and permanent solutions
• Communicate the status, results, and impacts of corrective actions to the appropriate stakeholders
• Ensures products and processes conform to SOPs, documented procedures, and expected quality levels.
• Develop, monitor, and publish quality metrics that will accurately represent the performance levels as they relate to deviations, complaints, CAPA's, self- inspections
• Assess procedures currently in place for compliance. Identify gaps and make recommendations on improving compliance
• o Manages the storage of retained samples
• o Revise GMP documentation (SOP's, Forms, etc) via the change control system.
• o Develops test standards and procedures
• Assigned delegated Sr. QA Associate Responsibilities and acts as a back-up to Sr. QA Associate and Quality Director as required.
• Responsible for other duties as required.

SKILLS, KNOWLEDGE / EXPERIENCE REQUIRED TO PERFORM THE JOB

• Consistently applies company SOP's relative to production, quality, and pharmaceutical packaging.
• University degree /college certificate and 2-5 years of equivalent experience in the fields of math or science.
• Experience in the pharmaceutical industry and knowledge of GMP's.
• In-depth knowledge and experience with manufacturing and packaging processes.
• Exceptional attention to detail and accuracy in the maintenance of records and data.
• Excellent organizational, and time management skills to ensure deadlines are met.
• Effective interpersonal and teamwork skills.
• The ability to problem solve, coach as well as influence and negotiate at al levels within the organization.
• Extensive computer knowledge and adeptness with various software programs including Microsoft Word, Excel, Outlook and Database Management.
• Excellent mathematical as well as written and oral communication skills.
• The ability to oversee project assignments, direct daily activities and provide on the job training to temporary employees.

MENTAL EFFORT REQUIREDTO PERFORM THE JOB

Concentration and intense visual discernment during the scrutinizing and proofing of work in process. Attention to detail when utiliz