What are the responsibilities and job description for the Quality Assurance Senior Associate position at Advanced Bio-Logic Solutions Corp?
Description:
Note:
This position works a rotating shift schedule, Week 1: Monday, Tuesday, Friday, Saturday Week 2: Sunday, Wednesday, Thursday, ~12 hours per day 6:50 AM – 7:00 PM
Ideal Candidate:
Job Details:
Responsibilities Include the Following:
Preferred Qualifications:
Top 3 Must Have Skill Sets:
Pay Rate- between $30 - $35/Hr on W2 based on experience.
"This posting is for Contingent Worker, not an FTE"
Note:
This position works a rotating shift schedule, Week 1: Monday, Tuesday, Friday, Saturday Week 2: Sunday, Wednesday, Thursday, ~12 hours per day 6:50 AM – 7:00 PM
Ideal Candidate:
- GMP experience is a must, drive, Independent but able to work within a team structure, Proficient in Microsoft Office (e.g., Outlook, Word, Excel, PowerPoint, MS Teams), Knowledge of data integrity requirements, Excellent written and verbal communication skills.
Job Details:
- In this vital role, will be responsible for PQA (Plant Quality Assurance) On the Floor in support of Manufacturing activities.
- This position requires working directly with Manufacturing staff during bulk drug substance operations to facilitate real-time decision-making regarding quality requirements and deviations.
Responsibilities Include the Following:
- Provide Quality oversight to ensure that operations products are manufactured, tested, stored, and distributed according to current applicable regulations.
- Ensure that facilities, equipment, materials, organization, processes, procedures and products follow cGMP practices and other applicable regulations.
- Performs review and approval of cGMP processes, procedures, documents and records. Review logbooks, batch records, attachments, work orders, and other GMP documentation.
- Ensure that deviations from established procedures are documented per procedures.
- Ensure that production records and testing results are complete, accurate, and documented according to written procedures and cGMP requirements.
- Alert management of quality, compliance, supply and safety risks.
- Complete required assigned training to permit execution of required tasks.
- Responsible for being in clean room space for majority of time on shift which includes gowning in and out of frocks and coveralls.
- Communicating and collaborating with the PQA shift to ensure required tasks are completed
Preferred Qualifications:
- Bachelor’s degree and 2 years of Quality/Manufacturing work experience
- Experience working in a cGMP environment
- Experience with decision making
- Experience with analytical testing and/or general compendia testing
- Experience working with batch records and other GMP documentation
- Knowledge of data integrity requirements
- Proficient in Microsoft Office (e.g., Outlook, Word, Excel, PowerPoint, MS Teams)
- Experience collaborating within and across functional areas and demonstrated customer service focus
- Excellent written and verbal communication skills
- Ability to prioritize and navigate ambiguity, with minimal oversight, in a fast-paced environment
Top 3 Must Have Skill Sets:
- cGMP experience
- Experience collaborating within and across functional areas and demonstrated customer service focus
- Ability to prioritize and navigate ambiguity, with minimal oversight, in a fast-paced environment
Pay Rate- between $30 - $35/Hr on W2 based on experience.
"This posting is for Contingent Worker, not an FTE"
Salary : $30 - $35
