Partial Job Description
1) Accountable for compliance and Quality Control issues affecting the business, including state, federal, and local regulatory issues, training and development, product compliance, special handling regulations, and related information technology requirements.
2) Assures that the facility Quality Systems are maintained in compliance with cGMP, ISO9001 2008, ISO 13485, and 21 CFR part 11, part 7- subpart C (Recalls), and part 820 (Quality System Regulation) and company Quality requirements.
3) Advises teammates and clients on cGMP in regard to the warehousing and distribution of pharmaceuticals and medical devices in order to meet FDA, DEA, and other regulatory requirements.
4) Supports the Internal Audit program and may also perform external supplier audits as required.
5) Works with Management to ensure that client project implementations are in compliance with regulatory requirements and those clients specifications are written and understood by local teammates.
6) Teams with Director to complete all process and system validations.
7) Develops, implements, and monitors Quality System policies and procedures to assure products distributed and stored comply with client and Regulatory requirements.
8) Supports, and delivers as needed, compliance training for teammates.
9) Manages investigations and resolution of non-conformances and CAPA as required.
10) May interface with clients and their QA organizations to review policies and procedures, regulations, and work instructions.
11) Participates and assists in Client Prospect and internal audits.
12) Conducts regulatory and safety training for teammates.
13) Ensures, through teammates and resources, that all relevant regulations and characteristics affecting products are reflected in the product master file, work flow and other related software tools.
14) Understands the compliance of software to new or existing regulations including CFR 21 part 11 (Validation) and provides guidance to teammates in developing software to be in compliance.
15) Supports Director in developing and implementing strategy and direction for the compliance function for company services and technology and in measuring the success of that strategy.
16) Assists Director and Operations teams as needed in the build out of the business such that it is in compliance with regulatory and operating requirements.
17) Monitors and reports progress of the business against agreed upon compliance goals and objectives. (KPI?s)
18) Provides input and review on standard processes and work instructions for warehouse management and inventory management to support regulatory or operational compliance requirements.
19) May also perform similar support function for product recall management and transportation management standards.
20) May serve as representative to conduct Management Reviews; must obtain any applicable state and other licensing to become a designated representative.
21) Assists Director to interface with clients and their QA organizations to review policies, procedures, regulations and work instructions.
22) Guides teammates and resources involved in legal regulatory compliance issues, including research, regulation interpretation and interaction with outside parties.
23) Assists in the timely and proper filing of required forms for DEA, FDA, State, etc.
24) Assures that all applicable state licenses are renewed on time.
25) Oversees the management of the Document Control system as applicable.
26) Performs Quality inspections as required.
Qualifications / Skills Required
1) University degree is required (preference will be given to those with degree in relevant field, though all candidates are welcome and encouraged to apply)
2) Appropriate full-time work experience is mandatory (no students or fresh graduates please)
3) Life sciences industry experience
The Life Sciences practice of Sterling-Hoffman was formed with a simple purpose:
help biotechnology, pharmaceutical & medical device...