Job Description

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. Maintains QA documentation and records. Conducts in-process as well as final inspections. Works closely with production and customer service to ensure customer specifications are met and that these specifications comply with internal operating standards.
SKILLS, KNOWLEDGE/EXPERIENCE REQUIRED TO PERFORM THE JOB
QA certificate or equivalent experience.
University/college degree in the fields of math, science or related discipline.
Experience in the pharmaceutical industry and knowledge of GMPs.
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 all levels within the organization.
Extensive computer knowledge and adeptness with various software programs including Microsoft Office, Microsoft Excel and database management.
Excellent written and verbal communication skills.
The ability to oversee project assignments and direct daily activities.
MENTAL EFFORT REQUIRED TO PERFORM THE JOB
Concentration and intense visual discernment during the scrutinizing and proofing of work in process. Attention to detail when utilizing the PC and data entering information. Mental attentiveness and professionalism with providing commentary or co-ordinating people and tasks. Requires an ability to multitask.
PHYSICAL EFFORT REQUIRED TO PERFORM THE JOB
Requires significant amount of walking and standing on a concrete floor. Works at a computer terminal for long periods of time entering and analyzing data.
RESPONSIBILITIES ASSOCIATED WITH PERFORMING THE JOB

• Consistently applies company SOPs relative to production, quality and pharmaceutical standards.
• Performs quality control inspections at prescribed intervals in the production process/cycle.
• Inspects, conducts sample assessments and logs statistical data of incoming product and materials.
• Manages the storage of retained samples.
• Develops test standards and procedures.
• Guides, coaches and directs production staff with respect to Quality issues and concerns using collaborative problem solving skills.
• Trains new staff in PCI\xe2\x80\x99s Quality Management Systems and processes.
• Complies and maintains QA documentation and data.
• Signs off Material Requisition Forms for the packaging, destruction, QA samples, rejects and any adjustments of pharmaceutical components and/or end use products.
• Performs final release of all material in ERP system.
• Updates and maintains the integrity of the QA database.
• Documents expected results and updates database with analyzed results.
• Consistently evaluates BPS quality control methods, policies, etc. and makes recommendations for improvement.
• Assists Sr. QA Associate and/or Quality Director with the preparation of quality audits.
• Investigates, develops, and documents Deviation/Incident Reports with the guidance from the Sr. QA Associate and/or Quality Director.
• Reviews and approves executed inspection and production related documentation.
• Responsible for monitoring and adhering to GMP as well as Health & Safety Practices under the Occupational Health & Safety Act, raising concerns or issues to the Sr. QA Manager.
• Reviews and maintains calibration logs.
• Inspects Return Material from the sites.
• Responsible for other duties as required.

SUPERVISION
Reports to the Quality Director. Established work schedule based on production needs and instructions from Sr. QA Associate.
WORKING CONDITIONS WHILE PERFORMING THE JOB
Works in climate-controlled office (70%) and warehouse and packaging rooms (30%). Exposure to cold temperatures i.e., Freezers, cold rooms, etc. Limited exposure to non-potent pharmaceuticals. Works with frequent interruptions both in person and by telephone.

Join us and be part of building the bridge between life changing therapies and patients.
Let\xe2\x80\x99s 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.