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QA Group LeadPCI TRGR Penn Pharmaceutical Services Ltd • San Diego, California, United States
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QA Group Lead

PCI TRGR Penn Pharmaceutical Services Ltd
  • US
    San Diego, California, United States
  • US
    San Diego, California, United States
Jetzt Bewerben

Über

SUMMARY The QA Group Lead is responsible for performing a wide variety of semi‑routine, moderate to highly complex activities pertaining to assuring compliance with applicable regulatory requirements, providing QA oversight of manufacturing operations, documentation and record management, facility and equipment management, change controls, investigations, and support of validation activities. The role includes coordinating and coaching junior QA staff to resolve issues and ensure compliance with applicable regulations and client requirements. ESSENTIAL JOB FUNCTIONS Leads the review and approval of executed technical documentation in support of the manufacture and testing of Drug Substance and Drug Product. Ensures completeness and accuracy of information contained in all documents, document files, databases, and documentation systems. Coordinates and schedules quality functions to support cGMP processes. Supports cGMP activities by providing oversight, guidance, and quality decision making. Communicates shift team status to other team leaders within QA and other cross‑functional departments as needed. Monitors and communicates team metrics. Coaches cross‑functional team members to ensure compliance with internal documents and applicable regulations. Independently investigates, troubleshoots, and rectifies issues as a result of QA analysis. Performs review of production records and associated data to ensure compliance. May be responsible for batch approval/rejection. Provides training, leadership, and guidance to QA personnel. Maintains regular and reliable full‑time attendance. Exhibits professional behavior with both internal and external business associates that reflects positively on the company. Embodies PCI’s cultural values and aligns daily actions with department goals and company culture. EDUCATION AND EXPERIENCE Bachelor’s degree in Life Sciences discipline or equivalent. Minimum of four (4) years of relevant experience in documentation review, QA, or equivalent. Minimum of one (1) year of functional leadership experience. Working knowledge of cGMP regulations 21CFR Part 11, 210, 211, 600 & EU guidelines and good documentation practices. Knowledge of cGMP operations within medical device or pharmaceuticals. Fill, Finish and Biologics production environments are preferred. LEADERSHIP RESPONSIBILITIES Champions PCI Pharma Services culture and empowers employees to take responsibility for their jobs and goals. Engages employees by creating a climate in which they want to do their best. Sets performance standards and encourages employee engagement and results through delegation, continuous feedback, goal setting, and performance management. Maintains employee work schedules. Provides oversight and direction to employees in accordance with PCI Pharma Services policies and procedures. SALARY & BENEFITS The hiring rate for this position is $36.54 - $41.10 per hour plus eligibility for an annual performance bonus. 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). 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.
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  • San Diego, California, United States

Sprachkenntnisse

  • English
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