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Sr BQ Specialist


Rocky Mount, NC
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Job Details

Job Title Sr BQ Specialist

JobID 1610262

Location: Rocky Mount, NC

Description The Biological Quality (BQ) department is seeking a highly motivated and experienced senior laboratory analyst to join our BQ Final Product team located in Rocky Mount, NC. The Senior BQ Specialist position is a laboratory analyst position and will be required to perform benchwork. Occasionally lifting and bending will be required. The position will directly report to the laboratory supervisor.

The ideal candidate is self-motivated and possesses a high level of independence; requiring minimal management direction. Strong organizational skills and discipline are keys to maintaining efficiency within the lab. The ideal candidate will possess both of these qualities and will strive to be efficient by prioritizing and performing tasks right the first time. Excellent communication skills are essential; as the senior analyst will be required to communicate technical information with both internal and external customers. The senior analyst works closely with supervision and management to identify opportunities to improve testing efficiencies and reduce laboratory error and lead subsequent related projects. The ideal candidate has a positive outlook and demonstrates engagement in helping to achieve BQ laboratory team and individual goals. When faced with issues, the senior analyst routinely offers suggestions and leads improvement and/or remediation efforts. The ideal candidate has demonstrated knowledge of cGMP, pharmaceutical microbiology industry standards and general laboratory principles.

The responsibilities of the Senior BQ Specialist position include but are not limited to:

+ Perform analyses including automated methods utilizing prescribed test methods and techniques. The analyst will perform a variety of microbiological and bioanalytical testing; including, Bacterial Endotoxins Testing (BET), sterility testing, particulate analysis, potency and antibiotic assays, to support the release of product and assist in making quality decisions.

+ Perform review of testing data through the peer and supervisory review process, which includes overall documentation practices, calculation confirmation and validity and acceptance criteria.

+ Maintain instruments and equipment through preventative maintenance measures and troubleshoots minor instrumentation problems.

+ Interact effectively with teams across departments and functions to increase efficiency, solve problems, generate cost savings and improve quality.

+ Investigate laboratory incidents, Out of Specification (OOS), Out of Tolerance (OOT) and Suspect laboratory results.

+ Collect, review and analyze laboratory data trends in support of product review and quality decisions.

+ Author and review technical laboratory documents, such as, scientific protocols, Standard Operating Procedures (SOP), validation protocols, etc.

+ Provide training to inexperienced analysts, working as a Certified Fellow Employee (CFE) and mentor to aid in their development as analysts.

Technical Skill Requirements


+ Experience with Bacterial Endotoxins Testing (BET) and other microbiological and/or bioanalytical methods.

+ General understanding of implications of pharmaceutical manufacturing microbiological contamination and detection principles.

+ Demonstrated scientific documentation skills and technical writing skills

+ Basic computer skills

+ Collaborative and leadership skills


+ Experience with computerized laboratory documentation systems - LIMS and TrackWise

+ Advanced computer skills and data management experience.

Education and Experience

+ BS in Biology or BS in related science field

+ At least 4 years of microbiological/bioanalytical laboratory experience in a GMP regulated environment.

+ Demonstrated career progression with increasing responsibilities in designated roles

**EEO & Employment Eligibility**

Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.

**Sunshine Act**

Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.

**Additional Offer Details:**

+ **Last Date to Apply for Job: September 20, 2017**

+ **This job is Hospira Non-exempt)US Grade** **:9**

A career at Pfizer offers opportunity, ownership and impact.

All over the world, Pfizer colleagues work together to positively impact health for everyone, everywhere. Our colleagues have the opportunity to grow and develop a career that offers both individual and company success; be part of an ownership culture that values diversity and where all colleagues are energized and engaged; and the ability to impact the health and lives of millions of people. Pfizer, a global leader in the bio-pharmaceutical industry, is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives.

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

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