Sr. Quality Control Analyst
This position performs as Quality Control (QC) Analyst that will primarily provide analytical support for the manufacture, release, and stability testing of drug substance produced at AbbVie DSO. The requirements for this QC Analyst position are as follows:
Knowledge:
o Has a general understanding of the analytical techniques used in the QC department within the analysts discipline. o Is still acquiring higher level knowledge and skills o Has a general understanding of regulatory documents and understands where to get further information or interpretation as issues come up. o Provides solutions to a limited range of moderately difficult problems. o Has a general knowledge of GMP principles and requirements. Able to work in close proximity to:
o Chemicals, oils, solvents and drugs o Biological product including controlled substances and toxins o The handling of drug compounds and excipients o An environment where gowning and respiraors are required Leadership:
o Works under general supervision o Follows established procedures. o Work is reviewed for soundness of judgment as well as overall accuracy. o Identifies and communicated issues as they occur with proposed solutions. o Maintains a work positive environment through emotional maturity, interpersonal communication and conflict resolution. o Takes direction, guidance, and constructive feedback form more senior peers. o Operates effectively in a fast paced work environment. o Understands how actionable plans relate to goals. o Maintains flexibility in a dynamic work environment. Communication:
o Proficient at GMP documentation. o Effectively communicates technical concepts to peers and management. o Adapts and customizes message based on audience. o Occasionally collaborates with departments in the conduct of day to day operations including special projects. o Represents BLI-QC department on cross functional teams within DSO. o Effectively communicates in a diverse and multicultural environment. o Effectively communicates with regulatory inspectors with facilitation from DSO management. Administration:
o Occasionally communicates on behalf of AbbVie to contract entities. o Communicates AbbVie standards of quality to contract entities. o Works with contract entities during investigation of analytical results. o Able to understand big picture and how individual tasks affect departmental and site goals. o Completes activities to meet critical objectives. KEY DUTIES AND
Responsibilities:
% of Time 1. Provide analytical support for the manufacture, release, and stability testing of drug substance produced at DSO 50% 2. Leadership and communication 30% 3. Regulatory compliance and validation activities 10% 4. GMP systems support including software support and SOP maintenance 5% 5. Continuous improvement 5%
Salary Range:
$80K -- $100K
Minimum Qualification
Quality AssuranceEstimated Salary: $20 to $28 per hour based on qualifications.
Knowledge:
o Has a general understanding of the analytical techniques used in the QC department within the analysts discipline. o Is still acquiring higher level knowledge and skills o Has a general understanding of regulatory documents and understands where to get further information or interpretation as issues come up. o Provides solutions to a limited range of moderately difficult problems. o Has a general knowledge of GMP principles and requirements. Able to work in close proximity to:
o Chemicals, oils, solvents and drugs o Biological product including controlled substances and toxins o The handling of drug compounds and excipients o An environment where gowning and respiraors are required Leadership:
o Works under general supervision o Follows established procedures. o Work is reviewed for soundness of judgment as well as overall accuracy. o Identifies and communicated issues as they occur with proposed solutions. o Maintains a work positive environment through emotional maturity, interpersonal communication and conflict resolution. o Takes direction, guidance, and constructive feedback form more senior peers. o Operates effectively in a fast paced work environment. o Understands how actionable plans relate to goals. o Maintains flexibility in a dynamic work environment. Communication:
o Proficient at GMP documentation. o Effectively communicates technical concepts to peers and management. o Adapts and customizes message based on audience. o Occasionally collaborates with departments in the conduct of day to day operations including special projects. o Represents BLI-QC department on cross functional teams within DSO. o Effectively communicates in a diverse and multicultural environment. o Effectively communicates with regulatory inspectors with facilitation from DSO management. Administration:
o Occasionally communicates on behalf of AbbVie to contract entities. o Communicates AbbVie standards of quality to contract entities. o Works with contract entities during investigation of analytical results. o Able to understand big picture and how individual tasks affect departmental and site goals. o Completes activities to meet critical objectives. KEY DUTIES AND
Responsibilities:
% of Time 1. Provide analytical support for the manufacture, release, and stability testing of drug substance produced at DSO 50% 2. Leadership and communication 30% 3. Regulatory compliance and validation activities 10% 4. GMP systems support including software support and SOP maintenance 5% 5. Continuous improvement 5%
Salary Range:
$80K -- $100K
Minimum Qualification
Quality AssuranceEstimated Salary: $20 to $28 per hour based on qualifications.
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