Serán BioScience
Pharmaceutical Manufacturing
QualityAssuranceAssociateII/III(SwingShift)
Neural analysis suggests this role is
optimal for Mid candidates.
“Quality Assurance Associate II/III (Swing Shift) at Serán BioScience. Skills: Quality Assurance, GMP, FDA regulations, CAPA, investigations, audits, inspections, documentation. support the daily activities of Serán’s Quality Assurance department by ensuring GMP regulations and internal SOPs are followed throughout the clinical manufacturing process. reviewing and approving production records, analytical data, and internal QA documentation”
What You'll Achieve.
ensuring GMP regulations and internal SOPs are followed throughout the clinical manufacturing process
Industry & Context.
analytical and problem-solving skills; Ability to solve complex problems; take a new perspective on existing solutions; exercise sound judgment based on the analysis of multiple sources of information to make independent decisions
Swing Shift, 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, Applicants must be authorized to work for an employer in the U. S., We are unable to sponsor or take over sponsorship of an employment Visa at this time.
What They're Looking For.
Must Have
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, Knowledge of GMP and FDA regulations, 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, analytical and problem-solving skills, 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, Applicants must be authorized to work for an employer in the U. S.
Nice to Have
commercial knowledge is desirable but not required, Oral Solid Dosage preferred
What You'll Do.
support the daily activities of Serán’s Quality Assurance department by ensuring GMP regulations and internal SOPs are followed throughout the clinical manufacturing process
reviewing and approving production records
and internal QA documentation
conducting risk analyses and investigations
participating in audits and inspections
Documents authorships
batch production and quality control (QC) records
certificates of analysis
and equipment qualifications
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
How You'll Work.
Team & Collaboration
work in cross-functional teams; maintains productive relationships with coworkers, clients, and other contacts outside the company; Communicates quality-related information to internal teams
Communication Scope
Communicates effectively; Excellent verbal and written communication skills; Communicates quality-related information to internal teams with minimal guidance
Process & Methodology
Manages corrective and preventive actions (CAPA), Manages controlled document issuance and archival, Ability to prioritize tasks and to delegate them when appropriate
Full Job Description
## Description 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. Serán BioScience develops and manufactures novel drug products for a variety of pharmaceutical applications. We aim to build a workforce that is collaborative, creative, and kind. In addition to the skills required of the role, qualified candidates will approach their work with integrity and enthusiasm to promote a positive work culture. Employees are awarded generous PTO accrual, low-cost health benefits, and a 5% 401(k) contribution that does not require an employee match or vesting. Want to learn more about what we do, who we are, and how you can contribute? We look forward to seeing your application. ## Duties and Responsibilities 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 archiva
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