Person2Person, LLC
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| QA Associate Based in Northern, NJ |
| Outstanding Contract opportunity with a global pharmaceutical Company focused on multiple therapeutic areas including Neurology, Oncology and Critical Care. They continue to move forward with an entry into biologics with the development of therapeutic antibodies and other such agents, which contributes to their innovate drug discovery process. Be a part of this global market leader! |
| SCOPE & DUTIES |
Performs batch/lot record review to ensure that all reviewed records have been executed per procedure
and meet all quality requirements. Responsible for the disposition decision for commercial product
manufactured at Baltimore.
Conducts investigations in collaboration with the production unit to fully understand the impact of the
deviation and determine appropriate CAPA.
Investigates product complaints and conducts follow-up with customer. Drafts or contributes to QA
documentation, including investigation reports, standard operating procedures, and annual product
reviews (APR)/product quality reviews (PQR). Trends Quality data.
May represent QA on cross-functional department teams and function as supervisor in the absence of
department manager. Trains other QA personnel on procedures. Requires minimal direction and
supervision.
• -Reviews executed commercial production records ensuring that records are in compliance with
GMP’s and standard operating procedures. Upon completion of review, assigns the appropriate
disposition.
• -Conducts, writes and performs risk assessments for investigations/deviations in collaboration
with the production unit to fully understand the impact of any deviation. With assistance from the
production unit determines root cause and assigns appropriate CAPA.
• -Product Complaints – Contacts customers, conducts and writes investigation, trends complaints,
collaborates with the production unit to fully understand the impact of the complaint, and with assistance
from production unit determines/assigns appropriate CAPA
• -Drafts or contributes to QA documentation, including investigation reports, standard operating
procedures, and annual product reviews (APR)/product quality reviews (PQR). Trends Quality data.
• -Represents QA at departmental meetings and on cross-functional department teams involving
Baltimore, ECL, and external partners and companies
-Other Duties/Responsibilities:
- Executes AQL inspections and sampling
- Performs Area Clearance
- Periodically summarizes status and progress of assigned activities as requested by supervisor.
and meet all quality requirements. Responsible for the disposition decision for commercial product
manufactured at Baltimore.
Conducts investigations in collaboration with the production unit to fully understand the impact of the
deviation and determine appropriate CAPA.
Investigates product complaints and conducts follow-up with customer. Drafts or contributes to QA
documentation, including investigation reports, standard operating procedures, and annual product
reviews (APR)/product quality reviews (PQR). Trends Quality data.
May represent QA on cross-functional department teams and function as supervisor in the absence of
department manager. Trains other QA personnel on procedures. Requires minimal direction and
supervision.
• -Reviews executed commercial production records ensuring that records are in compliance with
GMP’s and standard operating procedures. Upon completion of review, assigns the appropriate
disposition.
• -Conducts, writes and performs risk assessments for investigations/deviations in collaboration
with the production unit to fully understand the impact of any deviation. With assistance from the
production unit determines root cause and assigns appropriate CAPA.
• -Product Complaints – Contacts customers, conducts and writes investigation, trends complaints,
collaborates with the production unit to fully understand the impact of the complaint, and with assistance
from production unit determines/assigns appropriate CAPA
• -Drafts or contributes to QA documentation, including investigation reports, standard operating
procedures, and annual product reviews (APR)/product quality reviews (PQR). Trends Quality data.
• -Represents QA at departmental meetings and on cross-functional department teams involving
Baltimore, ECL, and external partners and companies
-Other Duties/Responsibilities:
- Executes AQL inspections and sampling
- Performs Area Clearance
- Periodically summarizes status and progress of assigned activities as requested by supervisor.
| REQUIREMENTS |
BS/BA or MS in Chemistry, or closely related field
• 2 to 4 years of experience in Quality Assurance within the pharmaceutical or closely related industry.
• Demonstrated experience performing batch record review and disposition, investigating product
complaints and conducting deviation investigations.
• In depth knowledge of CGMPs and Regulatory Guidelines.
• Excellent communication skills (oral and written)
• Demonstrated organizational skills
• Critical thinking with ability to identify issues requiring further attention, and ability to initiate and
facilitate resolution of those issues.
• Strong interpersonal relationship skills
• Computer skills including a working knowledge of Microsoft Office (Access, PowerPoint, Word and
Excel).
• Working knowledge of Trackwise desirable.
• Ability to work independently with minimal supervision and direction.
• Supervisory experience preferred by not required.
** Must have a Pharma background
**Must be Hands-On
**Must be an Independent worker able to work in a fast paced environment
• 2 to 4 years of experience in Quality Assurance within the pharmaceutical or closely related industry.
• Demonstrated experience performing batch record review and disposition, investigating product
complaints and conducting deviation investigations.
• In depth knowledge of CGMPs and Regulatory Guidelines.
• Excellent communication skills (oral and written)
• Demonstrated organizational skills
• Critical thinking with ability to identify issues requiring further attention, and ability to initiate and
facilitate resolution of those issues.
• Strong interpersonal relationship skills
• Computer skills including a working knowledge of Microsoft Office (Access, PowerPoint, Word and
Excel).
• Working knowledge of Trackwise desirable.
• Ability to work independently with minimal supervision and direction.
• Supervisory experience preferred by not required.
** Must have a Pharma background
**Must be Hands-On
**Must be an Independent worker able to work in a fast paced environment
| Executive Recruiting Specialists in the NY/NJ/CT Region |
Apply today! For immediate consideration, please email resume to: lsydor@person2personllc.com |