Quality Control Manager

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 DESCRIPTION:

Position Title: Manager, Quality Control

Location: San Diego, CA

Department: Quality – Inspection

The Manager of Quality Control oversees Quality Control in production and warehouse areas. The Manager of Quality Control will also provide support for investigations, complaints, CAPAs, inspections, product / material release, document control, quality metrics, audits, and continuous improvements. 

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Implement, monitor, and audit corrective actions
• Direct oversight of Quality Control for site
• Knowledge of and adherence to all PCI, cGMP, and GCP policies, procedures, and rules
• Complete complaint investigations
• Complete internal investigations
• Monitor and improve Internal Batch Record Right First Time
• Provide hands-on training for staff
• Collect quality metrics and make recommendations for continuous improvement
• Implement, improve, and maintain systems and processes for Quality Control
• Conduct and/or support internal, supplier, regulatory and customer audits
• May perform QC line clearances, in-process checks and monitoring of labeling and packaging activities on the floor
• May perform QC inspection or release of incoming GMP materials according to appropriate material specifications
• Perform NMR investigations
• Ensure department and company goals are met
• Performs other duties as assigned

QUALIFICATIONS:

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.

The base salary hiring range for this position is ($95,360 - $102,000) 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), flexible spending account, and 401(k).

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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.