Pharmaceutical Manufacturing QA Associate

Sanford, FL - USA

Monthly Salary: Not Disclosed

Posted on: 5 hours ago

Vacancies: 1 Vacancy

Job Summary

CORE JOB DUTIES:

Performs duties with the guidance of Sr. Associates
Execute real time review of batch documentation and other manufacturing documentation analyzing for errors corrections and compliance
Support Transfer Master Cell Banks to Manufacturing
Perform housekeeping and GMP walkthroughs of facility
Initiate deviations in real time and assists in investigations
Work in cross functional teams to meet and exceed timelines
Execute or review room and line clearances
Makes quality decision in real time according to regulations ICH Q7 and 21CFR211 and internal procedures

ADDITIONAL RESPONSIBILITIES

Support/initiate analytical test results initial investigation on the floor
Reviews and may approve manufacturing analytical testing on the floor
Uses analytical skills to help ensure shop floor compliance to internal standards and procedures
Draft and review Standard Operating Procedures
Perform other duties as assigned and take ownership to support the implementation of activities needed including but not limited to facility start-up and continuous operations.

Qualifications :

A Bachelors or Masters degree in a relevant discipline (e.g. microbiology chemistry biological sciences bioengineering etc.).
- Bachelors degree 2-4 years of relevant experience
- Masters degree up to 2 years of relevant experience
- Relevant experience includes:
  - Quality Assurance in GMP facilities drug substance preferred
  - Batch record review housekeeping monitoring GMP document review and/or creation.
  - Reviewing deviation reports change controls CAPA and analytical data.
  - Experience with Data Integrity
  - Knowledge of and experience in GMP following applicable regulations or willingness to become GMP proficient.
Authorization to work in the United States indefinitely without restrictions or sponsorship

Additional Information :

Position is full-time Monday - Friday 8:00am - 5:00pm. Candidates currently living within a commutable distance of Sanford NC are encouraged to apply.

Excellent full time benefits including comprehensive medical coverage dental and vision options.

Life and disability insurance
401(k) with company match
Paid vacation and holidays

Eurofins USA PSS Insourcing Solutions is a Disabled and Veteran Equal Employment Opportunity employer.

Remote Work :

Employment Type :

Full-time

CORE JOB DUTIES:Performs duties with the guidance of Sr. AssociatesExecute real time review of batch documentation and other manufacturing documentation analyzing for errors corrections and complianceSupport Transfer Master Cell Banks to ManufacturingPerform housekeeping and GMP walkthroughs of faci...

CORE JOB DUTIES:

Performs duties with the guidance of Sr. Associates
Execute real time review of batch documentation and other manufacturing documentation analyzing for errors corrections and compliance
Support Transfer Master Cell Banks to Manufacturing
Perform housekeeping and GMP walkthroughs of facility
Initiate deviations in real time and assists in investigations
Work in cross functional teams to meet and exceed timelines
Execute or review room and line clearances
Makes quality decision in real time according to regulations ICH Q7 and 21CFR211 and internal procedures

ADDITIONAL RESPONSIBILITIES

Support/initiate analytical test results initial investigation on the floor
Reviews and may approve manufacturing analytical testing on the floor
Uses analytical skills to help ensure shop floor compliance to internal standards and procedures
Draft and review Standard Operating Procedures
Perform other duties as assigned and take ownership to support the implementation of activities needed including but not limited to facility start-up and continuous operations.

Qualifications :

A Bachelors or Masters degree in a relevant discipline (e.g. microbiology chemistry biological sciences bioengineering etc.).
- Bachelors degree 2-4 years of relevant experience
- Masters degree up to 2 years of relevant experience
- Relevant experience includes:
  - Quality Assurance in GMP facilities drug substance preferred
  - Batch record review housekeeping monitoring GMP document review and/or creation.
  - Reviewing deviation reports change controls CAPA and analytical data.
  - Experience with Data Integrity
  - Knowledge of and experience in GMP following applicable regulations or willingness to become GMP proficient.
Authorization to work in the United States indefinitely without restrictions or sponsorship

Additional Information :

Position is full-time Monday - Friday 8:00am - 5:00pm. Candidates currently living within a commutable distance of Sanford NC are encouraged to apply.

Excellent full time benefits including comprehensive medical coverage dental and vision options.

Life and disability insurance
401(k) with company match
Paid vacation and holidays

Eurofins USA PSS Insourcing Solutions is a Disabled and Veteran Equal Employment Opportunity employer.

Remote Work :

Employment Type :

Full-time

Key Skills

Sales Experience
B2B Sales
Primary Care Experience
Biotechnology
Account Management
Territory Management
Computer Literacy
Outside Sales
Biomedical
Botox Experience
negotiation
Compounding Medications

Apply Now

About Company

Eurofins

Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and the environment safer, healthier and more sustainable. From the food you eat to the medicines you rely on, Eur ... View more

View Profile View Profile

AI AutoApply

Apply to 100+ jobs with one click