Quality Assurance Senior Associate - Advanced Bio-logic Solutions : Job Details

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 PMIdeal 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