Quality Assurance Engineer
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Serán BioScience is expanding and looking for a Quality Assurance Engineer with industry experience to join at this exciting time. The QA Engineer will be part of a cross functional team that will be responsible for the review and/or approval of qualification/validation of all the lifecycle activities associated with facilities, utilities, equipment, process, cleaning, and computerized systems. The focus of this position will be to support the Commercial Manufacturing Facility that is currently underway.
The development and execution of these deliverables requires direct communication with internal and external cross functional teams. Successful candidates will understand that effective communication is essential for alignment on strategies and approaches, and correcting deficiencies while maintaining good working relationships. Qualified candidates will have a thorough understanding of current regulations and guidelines such as but not limited to 21 CFR Parts 11, 210, and 211, EudraLex Volume 4, Annex 15, and GAMP 5 is required.
Duties and Responsibilities
- Generates and/or supports the generation of risk assessments, user requirements specifications (URS), C&Q plans, change controls, SOPs, CAPAs, and other relevant documents
- Supports validation lifecycle activities such as, but not limited to, change management, periodic reviews, and re-qualification to ensure that qualified systems remain in their validated state
- Makes compliance decisions to support commercial operations
- Mentors colleagues on the reasons or justifications of the requirements and practices
- Drives process improvement initiatives
- Provides support during clients and regulatory audits
- Performs other related duties as assigned
- Responsibilities may increase in scope to align with company initiatives
Required Skills and Abilities
- Understanding of current regulations and guidelines (e.g., 21 CFR Parts 11, 210, and 211, EudraLex Volume 4 - Annex 15, GAMP 5, etc.) and how to apply them to support the validation effort
- Technical writing skills to effectively develop procedures, discrepancies, change controls, CAPAs and associated documents needed to support the validation effort
- Hands-on experience with the qualification of facilities, utilities, equipment and/or computerized systems, cleaning or process validation (Experience in at least two of these areas is required)
- Ability to manage multiple projects, create and work within internal timeliness, solve problems, deliver on commitments, and utilize interpersonal skills in a cross-functional team
- Strong time-management skills and the ability to organize and coordinate multiple projects at a time
- Communicates effectively and maintains productive relationships with coworkers, clients, and other contacts outside the Company
- Ability to prioritize tasks and to keep leadership apprised of performance to timelines
- Accepts feedback from a variety of sources and constructively manages conflict
- Experience in Oral Solid Dose operations and spray drying is preferable
- Proficiency in enterprise systems, Microsoft Office, and other office productivity tools, with aptitude to learn new software and systems
Education and Experience
- Bachelor’s degree in a science, engineering, or related field
- Minimum of 4 years required within pharmaceutical industry, with preference given to those with 5-10 years of experience
- Minimum of 4 years of experience performing qualifications and/or validations is required
Physical Requirements
- Prolonged periods sitting at a desk and working on a computer
- Prolonged periods of mobility between offices and campus buildings
- Adheres to consistent and predictable in-person attendance
Visit to learn more about company culture and the community of Bend, Oregon.
Level and compensation will be based on experience.
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
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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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