Quality Assurance Associate II/III (Swing Shift)
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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.
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 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
Required Skills and Abilities
- 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
Education and Experience
- 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
Physical Requirements
- 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
Visit to learn more about company culture and the community of Bend, Oregon.
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.
Benefits Summary:
Serán employees accrue over four weeks of paid time off annually. Employer contributions to a retirement account begin after 90 days and do not require an employee match or vesting period. Various health plans allow employees to find the best coverage for their individual or family needs with minimal employee contributions. Serán covers each employee with basic life and long-term disability, giving access to increase or add coverage. An Employee Assistance Program provides support for all things related to our employees’ wellbeing, along with access to pet insurance.
The Corporate Headquarters of Serán BioScience are located at 63047 Layton Ave, Bend, OR 97701
Skills
As published by lever · 21 questions
Basics
Resume/CV, Full name, Email, Phone, Current location, Current company
Short answers (5)
- If someone from Serán initiated contact and referred you to this role, please type their name below optional
- If yes, please explain: optional
- Please indicate your desired compensation: optional
- What is your date of availability for employment? optional
- Are you subject to any restrictions related to potential employment with Serán? Restrictions include noncompetition, nonsolicitation, no hire, or confidentiality. If yes, please provide an explanation (include name of company and description of restriction without disclosing any confidential or proprietary information to Serán)
Pick from a list (15)
- Have you ever worked for Serán BioScience before?
- Do you have experience in the pharmaceutical industry?
- Without providing dates of enrollment, can you confirm that you have completed the necessary education requirements of the position? optional
- Are you able to perform the essential functions of this job without reasonable accommodations? Note: We comply with the ADA and consider reasonable accommodation measures that may be necessary for qualified applicants/employees to perform essential job functions.
- As of this date, can you present evidence of your identity and legal right to work in this country?
- Would you need VISA sponsorship now or in the future?
- Can you travel if the position requires it?
- Can you relocate if the position requires it?
- Have you ever been terminated from or asked to resign from a job? optional
- I certify that all statements made in connection with this application (whether contained herein (and/or any supplements) or made by me or others at my request during the course of the employment process) are true and complete in al respects. I acknowledge and agree that any incorrect, incomplete, false, fraudulent, or misleading statements made by me, either verbally or in writing, and/or any omission, concealment, or failure or answer any question fully, completely, and accurately, whether made by me or others at my request, will result in rejection of this application, denial of employment, or termination from employment if discovered after employment.
- I authorize the investigation of all matters which Serán deems relevant to my qualifications for employment, including, without limitation, work records, reference checks, education, and an investigation into my driving record. I authorize and request that all my present and former employers, references, educational institutions, and any others to furnish and release information about me, my employment record, and/or education, including a statement of reason for the termination of my employment and information regarding my work performance, disciplinary reports or actions, abilities, degrees obtained, transcripts, licenses and certifications, and other qualities and information Serán deems pertinent to my qualifications for employment. I release Serán (and all providers of information) from all claims and/or liabilities arising out of or in any way connected with Serán's background investigation. If employed, I release Serán from any claims and/or liabilites for future references it may provide regarding my work history and performance with Serán.
- I understand that if offered employment, I will be required to submit proof of my identity and legal right to work in the United States as a condition of employment.
- I understand that any job offer may be contingent on me successfully passing a criminal background check/investigation. I release Serán from all claims and/or liabilities resulting from or related to the criminal background check/investigation.
- I understand that any job offer may be contingent on me successfully passing a pre-employment drug screen. I agree to hold harmless and release Serán and its agents from all claims and/or liabilities resulting in whole or part out of the collection of specimens, testing and the appropriate use of the information from such testing.
- I understand that, if employed, my employment relationship with Serán will be at-will. Therefore, subject to applicable law, my employment may be terminated (and I may voluntarily resign) at any time, for any reason or no reason, with or without cause or prior notice. Nothing contained in this application, or provided in connection herewith, will be construed as an offer or promise of employment, nor does this application create any employment contract or guarantee that employment or any benefit will be provided or continued for any period of time.
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