FOR MORE DETAILS ON THESE POSITIONS AND OTHERS, PLEASE CALL RITA AT 609 716 7060 EXT 4100.  WE HAVE SEVERAL OTHER POSITIONS AS WELL.  THIS IS OUR DIRECT CLIENT.

NEW POSITION : QA SYSTEMS SPECIALIST

CANDIDATE SPECIFICATIONS:
•    BA/BS degree required in a related technical field.  Degree in other discipline if sufficient technical depth has been achieved by professional experience.
•    3-5 years pharmaceutical experience in a Quality Organization.
•    In-dept experience in quality systems, including validation, documentation, compliance in a high volume, rapid turnaround release office or compliance department.  Strong technical understanding of industry and science practicies related to the business.
•    Fully versed in GMP’s, NIH Guidelines, FDA and other regulatory agency requirements for validation and operations, analytical and stability functions and compliance.
•    Demonstrated ability to drive initiatives across multiple business units under tight deadlines.
•    Excellent analytical skills and attention to detail.
•    Strong communication and problem solving skills with a demonstrated ability to work well with and influence others without direct reporting relationships.
•    Must have demonstrated self-direct work habits and strong communication skills.
•    Sense of urgency, flexibility and accountability.
•    Ability to communicate at all levels.
•    Ability to work in a high complex matrix environment.
•    Must be a committed team player prepared to work in and embrace a team based culture.
•    Ability to follow written procedures and document results in a neat and precise manner.
•    Intermediate computer skills required.
•    Proven record of providing excellent internal and external customer service.
•    Stay current on developments in the field
•    Work within a Multi-skilled team.
•    Maintain attention to detail, while completing multiple or repetitive tasks.
•    Demonstrate a serious commitment to accuracy and quality while meeting goals or deadlines.
•    Maintain a high level of integrity while balancing multiple priorities and responsibilities.

POSITION #1 - COMPLIANCE SPECIALIST

•    B.S or B.A in a technical discipline, preferable Microbiology, Biology/Virology, Biochemistry, Chemistry or Pharmacy.  Degree in other discipline if sufficient technical depth has been achieved from profressional experience.
•    Minimum of 3 years pharmaceutical experience investigationg manufacturing deviations either in a QA or manufacturing role; preferable in Biologics Secondary Manufacturing.
•    Working knowledge of pharmaceutical facilities, equipment and systems.  Including  a technical understanding of industry and science practices related to the business in order to apply  knowledge to daily activities.
•    Demonstrated problem solving and investigational skills.
•    Knowledge of GMP’s, NIH Guidelines, FDA and other regulatory agency requirements sufficIent to apply to quality operations and compliance.
•    The ability to commuincate both verbally and in writing with all levels both inside and outside of the oragniziation.  The ability to clearly write technichal documentation as necessitated by regulatory agancies an internal policy.
•    Ability to establish and maintain working relationships with staff and the abiliy to analyize data and implement changes.  
•    Able to interact with peers, subordinate and senior personnel in multidisciplinary environment including engineering, facility operations, validation, production and QA.  Ability to work in a high complex matrix environment.
•    Able to prioritize and decide appropriate course of actions and to effectively  implementing decisions.
•    Ability to facilitate and generate the exchange of ideas to resolve problems, prioritize solutions, select optimal solutions and implement decisions.
•    Able to maintain attention to detail while executing multiple tasks.

POSITION # 2 - QA RELEASE SPECIALIST

•    BS or BA in a relevant technical discipline.  Degree in other discipline if sufficient technical depth has been achieved from professional experience.  
•    In-depth experience in quality systems, including validation, documentation and compliance in a high volume, rapid turnaround Release Office or compliance department.
•    Minimum of 2 years industrial experience in quality organizations, either in operations or assurance functions.  
•    Working technical understanding of industry and science practices related to the business.
•    Fully versed in GMP’s, NIH and WHO Guidelines, FDA and other regulatory agency requirements sufficient to comply to quality operations and compliance.
•    Computer skills in Microsoft Office applications and the ability to quickly and easily learn new applications.
•    Demonstrated ability to exhibit: flexible thinking; a willingness to develop oneself; the ability to build and maintain relationships; be customer focused; enable and drive change in a dynamic work environment; and exhibit a continuous improvement mindset.


PLUS TO HAVE

•    User experience with SAP is highly preferred.
•    Prior experience with licensed bio-pharmaceutical or biological products.

•    Able to perform job duties with minimal supervision.
•    Sense of urgency, flexibility and accountability.
•    Intermediate computer skills required.
•    Stay current on developments in the field
•    Demonstrate a serious commitment to accuracy and quality while meeting goals or deadlines.