Seranbio1mo ago

Quality Assurance Associate II/III (Swing Shift)

BendFull-time Exemptmid

QA & TestingQuality Assurance Lead

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Requirements Summary

00 pm and ending at 1:00 am.

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QA & TestingQuality Assurance Lead

Serán BioScience is searching for an experienced Quality Assurance Associate to aid in regulatory compliance for the manufacturing of oral solid dosage drug products. The primary responsibilities of this role will be to support the daily activities of Serán’s Quality Assurance department by ensuring GMP regulations and internal SOPs are followed throughout the clinical manufacturing process. Essential task include reviewing and approving production records, analytical data, and internal QA documentation. Additional responsibilities include conducting risk analyses and investigations and participating in audits and inspections. Quality experience in a GMP Pharmaceutical Manufacturing setting is a requirement for this position with the ability for the title and compensation to commensurate with experience.

This role will support the alternative manufacturing schedule from Monday - Thursday, beginning at 2:00 pm and ending at 1:00 am. Experience specific to Serán's manufacturing capabilities and confidence to make independent decisions in alignment with Company policies and risk mitigation philosophies will be critical to this role.

Documents authorships, reviews, and approves of SOPs, batch production and quality control (QC) records, certificates of analysis, method validations, and equipment qualifications

Applies working knowledge of best practices in GMP and understands how Quality integrates with other business areas

Initiates and oversees investigations

Manages corrective and preventive actions (CAPA)

Supports internal audits, client audits and regulatory inspections, with the potential to host

Manages controlled document issuance and archival

Performs quality reviews with minimal oversight

Communicates quality-related information to internal teams with minimal guidance

Responsibilities may increase in scope to align with company initiatives

Performs all other related duties as assigned

Knowledge of GMP and FDA regulations for clinical trial materials; commercial knowledge is desirable but not required

Confident understanding of change control procedures, CAPA program, investigation and root cause analysis, and good documentation practices

Excellent organizational skills and attention to detail

Excellent time management skills with a proven ability to meet deadlines

Strong analytical and problem-solving skills

Communicates effectively and maintains productive relationships with coworkers, clients, and other contacts outside the company

Demonstrates the ability to collaborate and work in cross-functional teams

Accepts feedback from a variety of sources and constructively manages conflict

Ability to prioritize tasks and to delegate them when appropriate

Excellent verbal and written communication skills

Ability to function well in a high-paced and at times stressful environment

Proficient with Microsoft Office Suite or related software

Ability to solve complex problems, take a new perspective on existing solutions, and exercise sound judgment based on the analysis of multiple sources of information to make independent decisions

Bachelor’s degree, preferably in a scientific discipline

3 years of GMP experience within a QC or QA role to meet the minimum qualifications for an Associate II

6 years of GMP experience within a QC or QA role to meet the minimum qualifications for an Associate III

Pharmaceutical Manufacturing experience required, Oral Solid Dosage preferred

Prolonged periods of sitting or standing at a desk and working on a computer

Must be able to lift up to 15 pounds at times

Ability to wear required personal protective equipment (PPE), including safety glasses, hearing protection, hard hat, and safety shoes

Adheres to consistent and predictable in-person attendance