QA Operations Specialist

The Senior QA Assurance Specialist is responsible for providing Quality Assurance Compliance support to Clinical or Commercial Operations. Responsible for a diverse and challenging set of activities, all of which are related to setting and maintaining quality standards aligned with US FDA cGMP and other applicable international GMP regulations and guidelines. Will work with Quality project teams and Clinical/Commercial Operations groups to assure appropriate consistency in GMP systems. Demonstrates the ability to function independently and productively. Has the ability to make significant, independent contributions to the development of new technologies and methodologies. Contributes to long-term strategic development of a project or function area. Organizes and provides written and/or oral presentations of work with minimal input from supervisor.
?Has solid experience in regulatory compliance. Is knowledgeable on US and international regulatory guidelines. Has built credibility within the group by performing high quality work.
?May have oversight responsibility. Has the confidence and technical knowledge to mentor junior staff. Train staff as necessary to ensure compliance with functional, GMP, and corporate training requirements.
?Identifies technical problems and utilizes problem-solving skills in consultation with supervisor. Provides guidance to other departments on compliance issues. Can independently design and carry out a series of studies to solve a problem or evaluate a process/procedure. Solutions may involve the development of new techniques and procedures. Uses the literature and colleagues as resources in order to solve problems.
?Participates in internal, regulatory, and corporate compliance audits and corrects deficiencies as required.
?May be involved in leading investigations on product complaints. Reports results through established systems.
?Author, review and edit documents as required such as annual product reviews and certification documents. Actively participates in investigations and compliance related issues.
?Carries out technical duties as assigned.

Requirements:
?BS w/10+ years., MS w/8+ years, PhD +0 years.
?Has received training in cGMP, relevant regulatory guidelines, and internal Wyeth policies and procedures. Working knowledge with database and/or electronic document management systems required (Microsoft Word, Excel) and familiarity with other software a plus (Microsoft Project, Access, etc.). Has considerable knowledge in a specific field or general knowledge across many areas of Quality. This may be relatively practical and focused, reflected in the application of specialized complex technologies, or conceptual, reflected in an ability to integrate intellectually complex and diverse pieces of information.
?BS in Chemistry or relevant science discipline with 10 plus years experience in Quality and/or a bio/pharmaceutical industry. MS in Chemistry or relevant science discipline with 8 plus years experience in Quality and/or a bio/pharmaceutical industry. PhD in Chemistry and/or relevant science discipline. Without PhD, 8-10+ years experience in a regulated environment in Quality Assurance, Quality Control, Compliance or Manufacturing.
?Experience with validation processes (systems, utilities, methods, and process) and manufacturing processes within a regulated environment and experience with biopharmaceutical equipment, systems, and utilities are required.
?Bio/pharmaceutical unit operations, aseptic processing, validation technology experience are a plus.




Wyeth offers competitive compensation and benefits programs including stock
options, child-care subsidies, flex-time, business casual attire,
educational assistance and professional development programs. Please
forward your resume with salary requirements and job reference code to the
address below.

For more information, visit our website at