Unicon Pharma Inc
Senior Specialist, GMP Operational Quality
Unicon Pharma Inc, Boston, Massachusetts, us, 02298
Senior Specialist, GMP Operational Quality
Find out if this opportunity is a good fit by reading all of the information that follows below. This is a
heavy Quality role ; a standout candidate will have:
Small Molecule/pharmaceutical/oral dose manufacturing (Quality)
Knows process and regulation and knows how to implement
Key Responsibilities
Supports quality oversight for root-cause analysis and product impact assessment for investigations as a result associated with deviations, OOS, and OOT investigations ensuring appropriate CAPA actions are identified.
Supports change control assessments, implementation, and closure.
Identifies and facilitates continuous improvement efforts.
Supports drafting and revising Quality Agreements between CMOs/Suppliers and the client, as needed.
Help represents the client's Quality on cross-functional working teams, applying strong communication and collaboration skills.
Performs the review of executed batch documentation from external and/or internal manufacturing and testing (executed batch records, release data, in-process controls, testing and stability data).
Use knowledge of functional area to inform decisions and support the success of batch disposition for drug substance, drug product intermediate, drug product and finished goods.
Supports GMP document review, including certificate of analysis, specifications.
Preferred Qualifications
Experience supporting multiple projects/teams within stated objectives and timelines.
Experience supporting cross-functional team members and collaborate effectively.
Good communication skills (written and verbal) and the ability to exchange potentially complex information.
Able to integrates activities with other groups, departments and project teams as needed.
Demonstrated ability to support evaluation of quality matters and solve straightforward problems using technical experience and judgement based on precedent.
Ability to work in a fast-paced environment and meet quality, accuracy, and timeliness objectives.
Expanded conceptual knowledge of cGMP's in a pharmaceutical setting.
Proficient in leading event investigations, Root Cause Analysis (RCA), and CAPA.
Operational QA experience in analytical or manufacturing setting with experience in small molecule manufacturing. Experience with biologics, devices, gene therapy a plus.
Practical GxP knowledge and understanding across lifecycle of the product including the application of:
GMP regulations and application to Manufacturing.
Root Cause Analysis methodology and tools.
Analytical techniques and data review
Ability to evaluate routine quality matters and make decisions utilizing risk-based approach.
Ability to communicate cross-functionally to a wide variety of audiences.
Relationship management/conflict management skills.
Seniority level
Mid-Senior level
Employment type
Contract
Job function
Quality Assurance
Industries
Pharmaceutical Manufacturing
#J-18808-Ljbffr
Find out if this opportunity is a good fit by reading all of the information that follows below. This is a
heavy Quality role ; a standout candidate will have:
Small Molecule/pharmaceutical/oral dose manufacturing (Quality)
Knows process and regulation and knows how to implement
Key Responsibilities
Supports quality oversight for root-cause analysis and product impact assessment for investigations as a result associated with deviations, OOS, and OOT investigations ensuring appropriate CAPA actions are identified.
Supports change control assessments, implementation, and closure.
Identifies and facilitates continuous improvement efforts.
Supports drafting and revising Quality Agreements between CMOs/Suppliers and the client, as needed.
Help represents the client's Quality on cross-functional working teams, applying strong communication and collaboration skills.
Performs the review of executed batch documentation from external and/or internal manufacturing and testing (executed batch records, release data, in-process controls, testing and stability data).
Use knowledge of functional area to inform decisions and support the success of batch disposition for drug substance, drug product intermediate, drug product and finished goods.
Supports GMP document review, including certificate of analysis, specifications.
Preferred Qualifications
Experience supporting multiple projects/teams within stated objectives and timelines.
Experience supporting cross-functional team members and collaborate effectively.
Good communication skills (written and verbal) and the ability to exchange potentially complex information.
Able to integrates activities with other groups, departments and project teams as needed.
Demonstrated ability to support evaluation of quality matters and solve straightforward problems using technical experience and judgement based on precedent.
Ability to work in a fast-paced environment and meet quality, accuracy, and timeliness objectives.
Expanded conceptual knowledge of cGMP's in a pharmaceutical setting.
Proficient in leading event investigations, Root Cause Analysis (RCA), and CAPA.
Operational QA experience in analytical or manufacturing setting with experience in small molecule manufacturing. Experience with biologics, devices, gene therapy a plus.
Practical GxP knowledge and understanding across lifecycle of the product including the application of:
GMP regulations and application to Manufacturing.
Root Cause Analysis methodology and tools.
Analytical techniques and data review
Ability to evaluate routine quality matters and make decisions utilizing risk-based approach.
Ability to communicate cross-functionally to a wide variety of audiences.
Relationship management/conflict management skills.
Seniority level
Mid-Senior level
Employment type
Contract
Job function
Quality Assurance
Industries
Pharmaceutical Manufacturing
#J-18808-Ljbffr