Job Description :
Company Overview:
Creating value by bringing together the right people to achieve results is our motto. Our clients and employees say they choose to work with us because of how we work with them - with service that exceeds their expectations and a personal commitment to their success.
Our client, is the world''s largest independent multinational biopharmaceutical company, seeks an accomplished QA Packaging Associate.
Notes:
Red Flags: If someone is looking for Quality Lab environment, this is not for them. The position supports a packaging and labeling operations that requires individuals to be able to gown, on their feet and mobile throughout the day, if someone is looking for a 100% desk job, this is not for them.
Interview Process: Phone screen (optional), Team panel, and individual with manager.
Description:
This position has primary responsibilities for providing support of clinical packaging operations. The incumbent will be responsible for responsibilities as defined below.
Providing direct floor support of packaging processes which includes approval of labels, in-process sampling of packaged goods, issue resolution and in-process review of batch records.
Perform final review and approval of all core and non-core batch records to ensure GMP and GDP compliance.
Ensure timely initiation, classification, closure and effectiveness evaluation of production deviation, CAPA''s, and Change Control records.
Be required to work with electronic systems such as SAP, MES, Trackwise, EDMQuality and Change Control. Tasks directly associated with the disposition of packaged lots.
The incumbent may be asked to give additional assistance to management within the Quality Assurance group as needed.
First 30 Days is all training with majority of it being hands on training on the process. Each day is highly dependent on the manufacturing schedule which causes our workload to change routinely throughout the day and week. Working closely as a team and with our clients allows us to deal with this high variability in daily schedules.
Basic Qualifications:
Bachelor''s degree in Life Science, Chemistry, Biological Science or Biochemistry.
2+ years of experience in quality assurance, quality control, or manufacturing in a biotechnology or pharmaceutical environment.
GMP Manufacturing or Quality Assurance experience.
Label and Packaging and/or Device Assembly experience.
Experience with controlled GMP documents, such as Standard Operating Procedures.
M-F (7-4) typical shift – may need to start at 8:30 as part of a staggered shift.
Preferred Qualifications:
Able to evaluate documentation and operations according to company procedures.
Effectively articulates quality requirements and rationale to others in writing and verbally.
Experience in reviewing and approval of batch records, NC/CAPA''s and Change Control records.
Knowledgeable of regulatory requirements/Quality Principles.
Able to effectively handle and operate in a rapidly changing environment. Strong team player. Complex decision making skills.
Knowledge of clinical packaging operations a plus.
I''d love to talk to you if you think this position is right up your alley.
If you''re looking for rewarding employment and a company that puts its employees first, we''d like to work with you. We''re driven, people driven. We also offer group health Insurance (employee paid on a pre-tax basis
NOTE: “Candidates that are offered a position are required to pass pre-employment drug and background screening”