Quality Assurance Specialist III
Bachem AG
Summary
The Quality Assurance Specialist III 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.
Job description
What you will do
- Perform all duties pertaining to a QA specialist I, and II 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 Req
- 4-6 years experience with GMP document control, validation, qualification and calibration. Pref
- 4-6 years Ability to work in ISO7 and ISO8 control environment and support real time batch record review. Req
- 4-6 years experience in internal auditing as well as working with regulatory agencies. Pref
- 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
Requirements
- Bachelor's Degree in organic chemistry or related field Required
- 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
- 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 Req
- 4-6 years experience with GMP document control, validation, qualification and calibration. Pref
- 4-6 years Ability to work in ISO7 and ISO8 control environment and support real time batch record review. Req
- 4-6 years experience in internal auditing as well as working with regulatory agencies. Pref
- 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
- CQA Preferred
- CQE certification desired Preferred
Benefits
- Competitive pay
- Annual performance bonus
- Medical, Dental & Vision
- 401(k) plan with employer contribution
- Paid vacation, personal and sick days
Company overview
Bachem AG is a leading Swiss biotechnology company specializing in the development and manufacturing of peptides and oligonucleotides. Founded in 1971 and headquartered in Bubendorf, Switzerland, the company has grown to become a global leader in the field with over 50 years of expertise. Bachem operates internationally with production facilities in Switzerland, the United States, and the United Kingdom, serving pharmaceutical and biotechnology companies worldwide. The company provides comprehensive services spanning from research-grade products to GMP manufacturing for clinical development and commercial applications. Bachem's product portfolio includes peptide new chemical entities (NCEs), oligonucleotide NCEs, commercial APIs, research chemicals, and diagnostic products. As a publicly traded company listed on the SIX Swiss Exchange, Bachem employs approximately 2,200 professionals globally and maintains a strong reputation for quality, innovation, and regulatory compliance in the pharmaceutical manufacturing sector.