- Serves as the quality subject matter expert related to all quality matters involving Mission's manufacturing, packaging, warehousing and supporting operations.
- Reviews and approves Mission's Good Manufacturing Practices (GMP) Master documents and oversees release of manufactured batches.
- Responsible for the Internal Audit and Supplier Audit Programs.
- Reviews and approves change controls, deviations, CAPAs, non-conformances, and customer complaint investigations in MasterControl.
- Communicates any Quality matters with Mission's customers as agreed upon in Quality Agreements.
- Facilitates and hosts customer audits to support review of Mission's manufacturing and quality systems.
- Participates/supports Regulatory audits of the facility by the FDA and other health authorities.
- Assist in the coordination and approval of annual product reviews; and sharing of approved reports with business customers (as required per contract).
- Conducts routine introductory training of new hires on the basic GMP requirements needed for the Pharmaceutical industry.
- Works with QA Director on continuous improvement projects for existing processes and Quality Systems.
- Bachelor's Degree from an accredited college or university and at least five (5) years of related experience and/or training; or equivalent combination of education and experience.
- Possess thorough understanding of U.S. cGMPs, applicable GMPs from other regulatory bodies for which Mission produces pharmaceutical products, and Mission's Quality Systems.
- Ability to maintain objectivity and perform root cause analysis.
- Possess excellent interpersonal and communication skills.
- Must have advanced computer software skills in Microsoft Office Suite.
- Knowledge of Master Control Quality Management and the Ross ERP system is preferred.
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Description
Job Description
Job DescriptionCOMPANY INFORMATION:
Mission Pharmacal Company ("Mission") is a privately held pharmaceutical company based in San Antonio, TX. For more than 75 years, the company has been improving the lives of people, through every stage of life, by identifying unmet healthcare needs and delivering innovative, high-quality prescription, over-the-counter products and medical devices to meet these needs using only the purest ingredients and state-of-the-art methods of manufacturing.
We are leaders in the therapeutic areas of women's health, urology, and dermatology. Mission provides a comprehensive portfolio of product and service offerings that help Mission and other pharmaceutical companies more effectively deliver needed prescription and consumer products into the hands of physicians, pharmacists and ultimately, patients.
GENERAL RESPONSIBILITIES:
The Quality Assurance (QA) Manager has overall responsibility for all internal quality assurance functions, which includes batch release and the execution of the following quality systems including: Complaints, Events (Deviations and non-conformances), (Corrective Actions/Preventive Actions (CAPAs), Effectiveness Checks, Annual Product Reviews and other quality related tasks. The Quality Assurance Manager leads the QA team in accordance with Mission's policies and applicable state and federal laws including but not limited to: interviewing, hiring and training employees; planning, assigning and directing work; appraising performance and developing team members coaching and counseling when appropriate; ensures a harmonious and efficient team operation by addressing concerns and resolving team issues.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
EDUCATION AND EXPERIENCE REQUIREMENTS:
The successful candidate must possess the following:
Mission offers competitive salaries and a comprehensive benefit package including a four-day work week, health insurance (medical, dental, vision), generous Paid Time Off plan, company match 401(k), STD/LTD and Life insurance and more
Mission Pharmacal believes the success of an organization is dependent upon its people. If you are a motivated professional who meets the above requirements, we look forward to meeting you
Mission is a government contractor
EOE/Minority/Female/Disabled/Veteran
Drug Free Workplace
