Specialist, QC Raw Materials
Company: Boehringer Ingelheim Pharmaceuticals
Posted on: May 13, 2022
minutes of inactivity. Job Description - Specialist, QC Raw
Materials (224737) Boehringer Ingelheim is an equal opportunity
global employer who takes pride in maintaining a diverse and
inclusive culture. We embrace diversity of perspectives and strive
for an inclusive environment which benefits our employees, patients
and communities. Specialist, QC Raw Materials - 224737 Description:
Responsible for revising/creating raw material specifications and
releasing raw materials for GMP use. Incumbent exercises judgment
within well-defined and established procedures and practices to
determine appropriate action on complex, non-routine projects;
identifies problems and generates alternatives and recommendations
within defined processes. Trains other staff, serves as a subject
matter expert and may be a lead within the team. As an employee of
Boehringer Ingelheim, you will actively contribute to the
discovery, development and delivery of our products to our patients
and customers. Our global presence provides opportunity for all
employees to collaborate internationally, offering visibility and
opportunity to directly contribute to the companies' success. We
realize that our strength and competitive advantage lie with our
people. We support our employees in a number of ways to foster a
healthy working environment, meaningful work, diversity and
inclusion, mobility, networking and work-life balance. Our
competitive compensation and benefit programs reflect Boehringer
Ingelheim's high regard for our employees. Duties &
- Create/updates raw material specifications and SOPs as
required. Maintains RM released data lot packets and reports.
Create RM final reports. Works with SQM and Quality Compliance on
material qualification. Coordinates with SCM and Logistics the
schedule for creation of new raw material specifications. Review
raw material lot packets to ensure appropriate samples are taken
and tested according to specification. Performs final disposition
and release of raw materials in SAP. Be a "Super User" of the SAP
system for disposition of Raw Materials.
- Performs an Owner role for Change Controls and Deviations.
Represents QCRM in cross functional meetings.
- Independently writes and/or updates raw material specifications
- Responsible for ensuring all raw material documentation and
reports are reviewed and are in accordance with the raw material
- Generates, reviews and/or maintains records or documents in a
detailed and consistent manner.
- Prepares sample reconciliation reports, periodic trend reports,
generate metrics and other reports as needed. Reviews and
reconciles reports with internally produced data. Maintains raw
material released data lot packets and reports, creates raw
material final reports.
- Process improvement and compliance:
- Pro-actively reviews and develops new raw material
specifications, standard operating procedures, protocols etc. to
ensure BI stays at the forefront of quality control practices.
Leads continuous improvement projects.
- Enters data in databases as appropriate.
- Performs an Owner role for Change Controls and Deviations.
- Represents QCRM in cross functional meetings. Acts as a "Super
User" of SAP system for disposition of raw materials.
- Involved in training and on-boarding of all level QC employees
and serves as a lead.
- Represents Quality Control raw materials group in
cross-functional meetings, shares subject matter expertise.
- Leads continuous improvement projects and acts as Quality
Control subject matter expert on continuous improvement projects.
- Requires a Bachelor's Degree in Biochemistry, Chemistry,
Microbiology, Molecular and Cellular Biology, or Biology (or
closely related degree with these core courses as the
- Six (6) years of quality control experience in the
pharmaceutical industry providing guidance to Manufacturing
Operations, QA, and other cGMP areas.
- Strong independent judgment and decision making abilities
- Strong knowledge of relevant regulatory guidances.
- Demonstrated problem-detection and problem-resolution skills
- Strong conflict resolution and negotiation skills
- Must possess demonstrated organizational skills that have
proven results in the ability to be self-directed while managing
- Must possess excellent verbal and written communication
- Knowledge of LIMS and Waters Empower Chromatography Data System
is desired. -
- Physical Demands / Surroundings - The duties of this position
may require the incumbent to exert some physical effort. Lifting
requirements may vary dependent of the QA area assigned. Weight is
typically no more than 25 pounds. Work environment is dependent
upon the area assigned.
- Visual Demands - Must be able to read and see clearly. -
- Temperaments/Mental Requirements - Frequently required to
exercise judgment and make decisions. Probable errors might cause
moderately serious delays, confusion, and could affect company
reputation/customer relations or expense to correct. - Eligibility
- Must be legally authorized to work in the United States without
- Must be willing to take a drug test and post-offer physical (if
- Must be 18 years of age or older Our Culture: Boehringer
Ingelheim is a different kind of pharmaceutical company, a
privately held company with the ability to have an innovative and
long term view. Our focus is on scientific discoveries that improve
patients' lives and we equate success as a pharmaceutical company
with the steady introduction of truly innovative medicines.
Boehringer Ingelheim is the largest privately held pharmaceutical
corporation in the world and ranks among the world's 20 leading
pharmaceutical corporations. At Boehringer Ingelheim, we are
committed to delivering value through innovation. Employees are
challenged to take initiative and achieve outstanding results.
Ultimately, our culture and drive allows us to maintain one of the
highest levels of excellence in our industry. Boehringer Ingelheim,
including Boehringer Ingelheim Pharmaceuticals, Inc., Boehringer
Ingelheim USA, Boehringer Ingelheim Vetmedica Inc. and Boehringer
Ingelheim Fremont, Inc. is an equal opportunity employer.
Minority/Female/Protected Veteran/Person with a Disability
Boehringer Ingelheim is firmly committed to ensuring a safe,
healthy, productive and efficient work environment for our
employees, partners and customers. -
Keywords: Boehringer Ingelheim Pharmaceuticals, Fremont , Specialist, QC Raw Materials, Other , Fremont, California
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