Quality Control Specialist: Client & Vendor Audits / Client Audits 9/7/2016
JOB DESCRIPTIONAPPLY MilliporeSigma is the North American life science brand of Merck KGaA, Darmstadt, Germany a leading science and technology company. It offers a broad range of innovative products and services to biotech and pharmaceutical drug therapies businesses. Through dedicated collaboration with the scientific and engineering communities, and as one of the top three R&D investors in the life science tools industry, the brand serves as a strategic partner to customers and helps advance the promise of life science.
Bioreliance is a division of MiliporeSigma.
SCOPE OF RESPONSIBILITY:
The scope of this individual contributor position within the US Biologics Quality Assurance department includes influence and impact within QA and across a variety of operations departments regarding GXP compliance.
PURPOSE OF THE POSITION
Performs a variety of tasks in support of specific areas of the quality system primarily in the Quality Assurance Client team (client audits, vendor audits, internal audits) and may provide support as needed Quality Assurance Data Audits team (data and report reviews), QA Technical Services (validation and assay documentation reviews), Quality Assurance Compliance team (deviations, CAPA and effectiveness checks) or Quality Archive function. Perform duties according to the principles of GLP and cGMP and other regulations.
Employee will be required to travel approximately 25 -30% of the time. Employee must be able to travel independently and work independently. Employee will make their travel arrangement in compliance with BioReliance Travel Policy.
ESSENTIAL JOB FUNCTIONS
* Schedules / books customer audits with BioReliance Operations groups as per established procedures. Liaises with customer representative, hosts customer audits and coordinates audit activities (including sending read-ahead material, scheduling tours, interviews and document retrieval). Processes client audit reports and generates BioReliance response letter.
* Performs Vendor qualification of BioReliance Vendors as per published schedule and in accordance with internal standard operating procedures and regulatory requirements. Liaises with vendor representative prior to audit. Request read-ahead material and other applicable vendor documents. Reviews vendor history and product history prior to audit. Review completed Vendor Questionnaires.
* Performs internal audits of different functions / areas as per published schedule and in accordance with internal standard operating procedures and regulatory requirement. Coordinates performance of internal audit with function / area representative. Reviews records and supporting documentation for auditing requirements. Interacts with other departments to ensure compliance with internal procedures, FDA and international regulations.
* Enter audit information and audit observations in the Quality Management System data base for Client Audits, Vendor Audits and Internal Audits. Generates audit reports; client audit responses and Quality Metrics (as needed). Tracks on-time and over-due audit responses
* Responsible for supporting client domestic and international regulatory submission by providing supporting document and communicating directly with applicable regulatory agencies. Assist with the completion of Quality Questionnaires and surveys
* Draft and finalize Quality Agreements for Clients, Suppliers and Subcontractors.
* Support Regulatory inspections
* Leads/implements/participates in projects with demonstrable process improvement and / or monetary savings to company. Suggests revisions to quality procedures to improve efficiency/accuracy
* Review and author SOPs as well as other documents for compliance requirements.
* Assist with training other QA personnel.
* Other GLP/GMP duties as assigned
Knowledge and Skills:
* Proficient knowledge of FDA regulations (cGMP, GLP, Part 11) and EMA regulations
* Advanced working knowledge of good documentation practices
* Strong Oral, written communication and interpersonal skills require
* Capable of making quality related decisions and provide guidance in areas of expertise
* Experience with electronic Quality Management, Learning Management and Document Manager preferred.
* Bachelor of Science Degree in Life Sciences (or Regulatory Affairs or Biotechnology) required
* A minimum of 2 years of experience in a GMP or GLP environment Working in a Quality position
* A minimum of 4 years of experience in a GMP/GLP environment, if no direct quality experience
* Ability to travel domestically and to Canada up to 35% REQUIRED
* Demonstrated capacity to be flexible, yet well-organized with strong time management and collaboration skills is critical and required
* Demonstrated effective professional communication is required
* Experience in working with Document Management systems (Trackwise or SAP strongly preferred)
* Experience with a customer facing/vendor management role in GxP environment is ideal
* A formal understanding of Regulatory Compliance as it relates to GMP/GLP is required (21 CFR parts 58 and 210, 211, 820)
* 4-6 years of experience in a GMP/GLP regulated environment with audit/regulatory experience is ideal
* Experience working with LIMS and ORACLE preferred
* ASQ or RAP certification for Quality Audit preferred
* Experience with EMA regulatory compliance is nice to have
* Subject Matter Expertise in Vendor/Customer audit is strongly preferred
The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law. This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to his/her Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because he/she made a good faith report of discrimination.