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 - 22 months ago