Unicon Pharma Inc
Senior Specialist, GMP Operational Quality
Unicon Pharma Inc, Boston, Massachusetts, us, 02298
Senior Specialist, GMP Operational Quality
Overview This range is provided by Unicon Pharma Inc. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more. Base pay range: $60.00/hr - $70.00/hr. Direct message the job poster from Unicon Pharma Inc.
Recruiter at Unicon Pharma | Quality & Compliance | Validation
Title:
Senior Specialist, GMP Operational Quality
Hours:
40 hrs/week
Duration:
24 months
Start:
ASAP
Interview Process:
2 rounds
This is a heavy quality role; a standout candidate will have small molecule/pharmaceutical/oral dose manufacturing (Quality), knowledge of process and regulation, and know 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.
Helps represent the clients 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 collaborates effectively.
Good communication skills (written and verbal) and the ability to exchange potentially complex information.
Able to integrate 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 cGMPs 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.
Minimum Qualifications Bachelor’s degree in a scientific or allied health field (or equivalent degree) and 8 years of relevant work experience, or equivalent combination of education and experience.
Notes from Manager 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
Seniority level
Mid-Senior level
Employment type
Contract
Job function
Consulting
Industries
Pharmaceutical Manufacturing and Biotechnology Research
Referrals increase your chances of interviewing at Unicon Pharma Inc by 2x. Get notified about new Operational Specialist jobs in Boston, MA.
#J-18808-Ljbffr
Overview This range is provided by Unicon Pharma Inc. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more. Base pay range: $60.00/hr - $70.00/hr. Direct message the job poster from Unicon Pharma Inc.
Recruiter at Unicon Pharma | Quality & Compliance | Validation
Title:
Senior Specialist, GMP Operational Quality
Hours:
40 hrs/week
Duration:
24 months
Start:
ASAP
Interview Process:
2 rounds
This is a heavy quality role; a standout candidate will have small molecule/pharmaceutical/oral dose manufacturing (Quality), knowledge of process and regulation, and know 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.
Helps represent the clients 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 collaborates effectively.
Good communication skills (written and verbal) and the ability to exchange potentially complex information.
Able to integrate 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 cGMPs 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.
Minimum Qualifications Bachelor’s degree in a scientific or allied health field (or equivalent degree) and 8 years of relevant work experience, or equivalent combination of education and experience.
Notes from Manager 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
Seniority level
Mid-Senior level
Employment type
Contract
Job function
Consulting
Industries
Pharmaceutical Manufacturing and Biotechnology Research
Referrals increase your chances of interviewing at Unicon Pharma Inc by 2x. Get notified about new Operational Specialist jobs in Boston, MA.
#J-18808-Ljbffr