Manager, Quality Operations
Impax Laboratories - Hayward, CA

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Essential Duties and Responsibilities include the following.
  • Develops and maintains quality assurance goals and objectives that are complementary and support corporate policies and goals.
  • Performs quality assurance review of design documentation to ensure compliance with stated requirements, including company quality records (SQARs, master MBRs, study protocols, PDRs, etc.)
  • Responsible for bulk batch disposition.
  • Reviews all data obtained during quality assurance activities to ensure consistency with company policies and procedures (completed batch records, in-process test results, AQL attribute inspection, etc.).
  • Leads investigations of product quality problems and writes investigation reports.
  • Reviews, approves, and closes out investigation reports.
  • Directs the activity of technical workers (30+) engaged in quality assurance activities.
  • Represents Quality Assurance at Material Review Board (MRB) meetings. Collects pertinent data and presents information to MRB.
  • Writes, reviews, approves company GMP-related policies and SOPs.
  • Manage, monitor, evaluate and coach QA personnel (30+) in the performance of their duties.
  • Reviews / approves documents related to process validation, cleaning validation
  • Participates in projects related to process validation and continuous improvement.
  • Serves as Dept lead in presenting QA’s position concerning decisions related to cleaning validations.
  • Designs and implements quality assurance training programs.
  • Responsible for the training and development of QA personnel on the night shift as well as other personnel (30+) whose work requires QA knowledge and skills.
  • Develops new approaches to solve problems identified during quality assurance activities.
  • Maintains a working knowledge of government and industry quality assurance codes and standards.
  • Other relevant duties as assigned.

Supervisory Responsibilities include oversight of QA Supervisors, Team Leaders, Associates and Technicians.

  • BS/BA degree in science and 8-12 years of pharmaceutical QA experience (within an oral solid dosage manufacturing environment strongly preferred).
  • Requires experience in auditing and with FDA inspections.
  • Knowledge/experience in DEA procedures for controlled substances desirable.
  • Excellent writing skills are required; must have the ability to write reports, memos, SOPs, proposals, etc.
  • Must have good verbal communication skills and must be able to prepare and deliver presentations (e.g. PowerPoint) to staff and/or senior management audiences.
  • To be successful an individual must model both professional and ethical behavior while managing employees and/or interacting with internal and external customers.
  • To be successful an individual must be organized and capable of multi-tasking, while at the same time remaining flexible to accommodate changing business needs.
  • Must be capable of working individually and delivering projects on time.
  • Must be able to work with “teams” and be responsible for fostering team participation and success.
  • Must be capable of applying knowledge, experience and training to make quick sound decisions.
  • Must be proficient with computers (e.g. Word, Excel, Access, PowerPoint etc.).

Physical Requirements and Working Conditions:
Requires the ability to sit, stand and walk for extended periods of time; communicate via telephone, computer and/or face-to-face contact; vision sufficient to monitor and use basic office equipment such as a personal computer, telephone, copier and FAX machines regularly in the course of work. Work is performed in an office, laboratory and manufacturing environments. Noise level in this environment is within a normal to moderate range.

IMPAX Laboratories - 2 years ago - save job
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