A rapidly growing specialty pharmaceutical company is seeking a motivated, detail-oriented Lab Technician – QC/Analytical Document Writer to support laboratory documentation activities at its Sacramento, California facility.
This position is responsible for preparing, revising, reviewing, and maintaining analytical and quality-control documentation in compliance with cGMP, FDA, ICH, and internal quality standards. The ideal candidate will have direct documentation experience within a GMP sterile-injectable or aseptic pharmaceutical environment, strong technical-writing skills, and excellent attention to detail.
This is a fully onsite position in Sacramento, California.
Responsibilities
- Prepare, revise, review, and maintain analytical and quality documentation, including:
- Test methods and analytical procedures
- Method-validation protocols and reports
- Specifications and standard testing procedures
- SOPs, control sheets, and control worksheets
- Change controls, deviations, CAPAs, investigations, and related reports
- Ensure laboratory documentation complies with cGMP, FDA, ICH, data-integrity, and internal quality requirements.
- Manage document-lifecycle activities, including version control, approval routing, issuance, archival, and traceability.
- Create, route, and monitor documents through electronic approval workflows using TrackWise, eInfoTree, or comparable quality-document systems.
- Enter, review, and maintain analytical data and laboratory workflows in StarLIMS or a comparable LIMS.
- Collaborate with Quality Control, Quality Assurance, Analytical Development, Research and Development, and Regulatory Affairs during document preparation and review.
- Support internal and external audits by retrieving and providing accurate, complete, and properly controlled records.
- Identify documentation discrepancies and coordinate corrections with the appropriate laboratory and quality personnel.
- Perform additional documentation-related duties and special projects as assigned.
Required Qualifications
- High school diploma or GED.
- Direct experience working in a cGMP pharmaceutical environment.
- Experience within sterile-injectable, parenteral, or aseptic pharmaceutical manufacturing or laboratory operations.
- Experience preparing, revising, reviewing, or maintaining controlled laboratory, analytical, or quality documentation.
- Working knowledge of GMP documentation practices, document control, version control, and data integrity.
- Strong proficiency with Microsoft Word, Excel, and Outlook.
- Strong attention to detail, organization, and proofreading skills.
- Excellent job-related written and verbal communication skills.
- Ability to manage multiple documents and priorities in a fast-paced, team-oriented environment.
- Ability to work fully onsite in Sacramento, California.
- Experience preparing test methods, specifications, STPs, analytical procedures, or method-validation protocols and reports.
- Experience documenting deviations, investigations, CAPAs, or change controls.
- Experience with TrackWise, eInfoTree, StarLIMS, or comparable eQMS, EDMS, or LIMS platforms.
- Experience supporting pharmaceutical regulatory inspections or internal quality audits.
- Flexibility to support different shifts or occasional weekend work based on business needs.
- Pay range: $25–$27 per hour
- Medical, dental, and vision coverage
- Paid time off
- 401(k)
- Additional incentive-program eligibility may apply
Employment is contingent upon successful completion of the company’s pre-employment screening requirements.
#IND-SPG
Estimated Min Rate: $25/hr
Estimated Max Rate: $27/hr
What’s In It for You?
We welcome you to be a part of the largest and legendary global staffing companies to meet your career aspirations. Yoh’s network of client companies has been employing professionals like you for over 65 years in the U.S., UK and Canada. Join Yoh’s extensive talent community that will provide you with access to Yoh’s vast network of opportunities and gain access to this exclusive opportunity available to you. Benefit eligibility is in accordance with applicable laws and client requirements. Benefits include:
- Medical, Prescription, Dental & Vision Benefits (for employees working 20+ hours per week)
- Health Savings Account (HSA) (for employees working 20+ hours per week)
- Life & Disability Insurance (for employees working 20+ hours per week)
- MetLife Voluntary Benefits
- Employee Assistance Program (EAP)
- 401K Retirement Savings Plan
- Direct Deposit & weekly epayroll
- Referral Bonus Programs
- Certification and training opportunities
Note: Any pay ranges displayed are estimations. Actual pay is determined by an applicant's experience, technical expertise, and other qualifications as listed in the job description. All qualified applicants are welcome to apply.
Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
Visit https://www.yoh.com/applicants-with-disabilities to contact us if you are an individual with a disability and require accommodation in the application process.
For California applicants, qualified applicants with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act. All of the material job duties described in this posting are job duties for which a criminal history may have a direct, adverse, and negative relationship potentially resulting in the withdrawal of a conditional offer of employment.
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
By applying and submitting your resume, you authorize Yoh to review and reformat your resume to meet Yoh’s hiring clients’ preferences. To learn more about Yoh’s privacy practices, please see our Candidate Privacy Notice: https://www.yoh.com/privacy-notice
