Commercial Quality Control Chemist I
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Serán is expanding its Bend, Oregon campus with a new GMP manufacturing facility and is seeking a Commercial Quality Control Chemist to play a critical role in the facility start-up of the new QC laboratory including equipment and facility qualifications. Once the facility is underway, the Commercial Quality Control Chemist will be responsible for performing routine and non-routine analytical testing in support of commercial pharmaceutical manufacturing, including facility testing, finished product release, stability programs, in-process control testing, raw material testing, and other quality control activities as assigned. The QC Chemist I executes analytical methods in accordance with approved procedures, cGMP requirements, and Good Documentation Practices (GDocP), ensuring accurate, reliable, and timely generation of analytical data. This position supports the Quality Control laboratory through effective execution of testing, proper documentation, equipment operation and maintenance, data review, and participation in laboratory investigations and continuous improvement initiatives.
Duties & Responsibilities
- Perform routine and non-routine analytical testing of commercial pharmaceutical products in accordance with approved analytical methods, specifications, SOPs, and laboratory procedures.
- Execute facility testing, finished product release, stability, in-process control, raw material, and other QC testing as assigned.
- Operate applicable laboratory instrumentation and perform analytical techniques, including HPLC, GC, dissolution, UV-Vis, FTIR, and other technologies as qualified.
- Prepare samples, standards, reagents, and solutions in accordance with approved procedures.
- Accurately calculate, document, and report analytical results within established testing timelines.
- Adhere to cGMP laboratory standards, Good Documentation Practices (GDocP), data integrity principles, and applicable regulatory requirements.
- Complete laboratory documentation ensuring accuracy and completeness.
- Review analytical data and supporting documentation for accuracy, completeness, and compliance with approved procedures.
- Maintain a clean, organized, and safe laboratory environment while following applicable safety and chemical hygiene procedures.
- Participate in investigations related to laboratory incidents, deviations, OOS, OOT, and other unexpected analytical results.
- Assist with root cause investigations and implementation of corrective and preventive actions (CAPAs) as assigned.
- Support analytical method transfers and method verification activities as assigned.
- Participate in laboratory training programs and maintain required training and qualification records.
- Support laboratory continuous improvement initiatives to improve testing efficiency, accuracy, compliance, and right-first-time execution.
- Assist in client inquiries, regulatory inspections, audits, and other QC activities as requested by QC management.
Required Skills & Abilities
- Strong understanding of cGMP laboratory practices and applicable regulatory expectations.
- Knowledge of Good Documentation Practices (GDocP) and data integrity principles.
- Working knowledge of analytical chemistry principles, laboratory techniques, and pharmaceutical testing practices.
- Demonstrated ability to accurately execute analytical methods and laboratory procedures.
- Strong mathematical, analytical, and problem-solving skills.
- Ability to interpret analytical results and identify atypical or unexpected data.
- Excellent attention to detail and organizational skills.
- Excellent time management skills with the ability to meet testing deadlines and commercial manufacturing schedules.
- Ability to prioritize multiple tasks in a fast-paced laboratory environment.
- Demonstrated ability to collaborate and work effectively in cross-functional teams.
- Excellent verbal and written communication skills.
- Ability to communicate analytical results, testing status, and laboratory concerns effectively.
- Ability to follow written procedures and work independently with appropriate oversight.
- Ability to accept feedback, adapt to changing priorities, and constructively manage conflict.
Education & Experience
- Bachelor’s degree in a scientific discipline or related field, with 1- 2 years of hands-on lab experience preferred; or
- Master’s degree in a scientific discipline or related field, with 1 year of hands-on lab experience preferred.
- Experience in pharmaceutical commercial QC testing preferred.
Physical Requirements
- Prolonged periods of sitting or standing at a desk and working on a computer.
- Must be able to lift up to 25 pounds at times.
- Adheres to consistent and predictable in-person attendance.
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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
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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