Sr. Quality Assurance Specialist

Bachem; Vista (CA); On-site; USD 97,000 - 134,000; Full time

Benefits offered by this job

Annual performance bonus

Medical/Dental/Vision coverage

401(k) plan with employer contribution

Paid vacation and sick days

Job summary

Bachem is seeking a Sr. Quality Assurance Specialist in California to drive GMP system improvements, review QC data, and guide QA activities across sites.

You will perform batch record reviews, support internal and customer audits, develop SOPs, and train teams to strengthen quality culture. A strong background in GMP documentation and ISO7/8 environments is required.

Qualifications

• Requires Bachelor's degree in organic chemistry or related field.
• Master's degree in organic chemistry or related field preferred.
• 5+ years in GMP manufacturing setting or 7+ with Associate degree.
• 4-6 years in Quality Assurance and GMP document control.
• Experience with ISO7/ISO8 environments and batch records.
• Auditing experience with regulatory agencies preferred.
• Excellent written and verbal communication skills.

Responsibilities

• Perform QA reviews and real time batch record review for electronic release.
• Suggest improvements to quality systems and SOPs using LEAN GMP.
• Review GMP documents including BPRs, validation protocols, data, and reports.
• Analyze data to identify trends and actionable insights.
• Close quality records and manage investigations (OOS) and document changes.
• Lead internal GMP audits and assist with customer/authority audits.
• Write and revise SOPs, specifications, and production quality docs.
• Train other departments to improve quality culture.

Skills

Quality Assurance

GMP compliance

Documentation review

Data analysis

Audit experience

Communication

Team collaboration

Problem solving

ISO7/ISO8 environment

SOP development

Education

Bachelor's in organic chemistry or related field

Master's in organic chemistry or related field

Associate's degree in science

Tools

Microsoft Word

Microsoft Excel

PowerPoint

Electronic batch release systems

Job description

A Brief Overview

The Sr. Quality Assurance Specialist fulfills a critical role in Quality Assurance. This individual will contribute an advanced level of understanding of GMP system improvements, technical documents, and review of GMP documentation and reports. This individual must also provide GMP and related guidance, data analysis, and technical review of QC data. in some instances, this role may act as the deputy for the Manager, Quality Assurance.

What You Will Do

• Perform all duties pertaining to a QA specialist I, II, III, in addition to those listed below.
• Support real time batch record review in a timely manner and with high accuracy, performing usage decisions in electronic batch release systems.
• Suggest and implement improvements in quality systems and SOPs taking into account LEAN GMP approaches.
• Reviewing and approval of all GMP documentation, which includes BPRs, validation protocols, data, reports, etc.
• Reviewing, analyzing, and trending data to extract relevant information.
• Work closely with other functions and sites to close out quality records, investigations e.g., OOS, and approval of documents and changes e.g., MBPRs, analytical procedures, protocols, reports, and specifications/global specifications.
• Suggests/recommends and implements new policies and procedures to improve existing processes and products.
• Problem resolutions with GMP systems as well as guiding on GMP topics.
• Be an active part in increasing the quality culture in the organization e.g., by guidance and training of other departments and sites.
• Perform GMP audits for internal operations, GMP compliance improvements and provide GMP compliance guidance to other departments and BAM Sites as needed.
• Support actively and able to take the lead in customer/authority audits. Writing new and revising current standard operating procedures (SOPs), specifications, etc. In addition, provide technical assistance on production and quality systems documents.

Qualifications

• Bachelor's Degree in organic chemistry or related field required or
• Master's Degree in organic chemistry or related field preferred
• Bachelor's Degree in a science related field and a minimum of 5 years' experience in a GMP manufacturing setting required or
• Associate's Degree in a science related field and a minimum of 7 years' experience in a GMP manufacturing setting required
• 4-6 years experience in Quality Assurance required
• 4-6 years experience with GMP document control, validation, qualification and calibration preferred
• 4-6 years Ability to work in ISO7 and ISO8 control environment and support real time batch record review required
• 4-6 years experience in internal auditing as well as working with regulatory agencies preferred
• Excellent written and oral communication skills
• Basic computer knowledge, including Microsoft Word, Excel and PowerPoint
• Ability to effectively organize, multitask and work in fast-paced, deadline driven work environment.
• Ability to communicate in a proactive and solution-focused manner, including keeping management aware of potential issues.
• Detail oriented with the ability to troubleshoot and resolve problems.
• Ability to work independently and manage one's time.
• Communicate effectively and ability to function well in a team environment.
• Certified Quality Process Analyst - ASQ preferred or
• CQA preferred or
• CQE certification desired preferred

Annual Salary Range

$97,174.20 - $133,614.80

Placement of new hires in these wage ranges is based on several factors including education, skill sets, experience, and training.

Total Rewards

We offer all Team Members a total rewards package including competitive pay, annual performance bonus, a generous benefit package with comprehensive Medical/Dental/Vision coverage, 401(k) plan with employer contribution, and paid vacation, personal and sick days.

Corporate Social Responsibility

Bachem takes responsibility for future generations by a careful handling of resources and avoiding environmental risks. We continually improve our ecological performance and develop and implement new approaches for enhancing employees’ environmental awareness. EcoVadis has awarded Bachem Gold Medal status in their assessment of Bachem.

Bachem Americas is an Equal Opportunity Employer

As an equal opportunity employer, we celebrate the diversity of our team and are committed to building an inclusive workplace where individuals are hired and advanced based on merit, skills, and qualifications. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran status, or other legally protected status.

At Bachem, you’ll find a diverse, multicultural team. The (a) in the job title stands for all. We welcome applications from all candidates. What matters are your skills and motivation—regardless of age, gender, background, religion, or sexual orientation.

Please note: unsolicited resumes from recruitment agencies will not be considered.