Shire Jobs

Mobile Shire Logo

Job Information

ALMAC Group Documentation Control Coordinator in Souderton, Pennsylvania

Almac Group is currently seeking a Document Control Coordinator for our Audubon, PA location. The Document Control Coordinator is primarily responsible for carrying out document control and project specific duties related to the general implementation and maintenance of Almac quality systems in accordance with Almac standard operating procedures (sops), current good manufacturing practices (cGMP), and customer specifications. Responsibilities include but are not limited to: *Create and maintain spreadsheets and databases of document reference numbers. Issue such numbers upon request. Ensure documents issued are GMP and Site SOP compliant. *Create, Issue and reconcile cGMP logbooks *Maintain control of SOPs and Policies by: *Maintaining the SOP Index *Copying SOPs/Policies and issuing authorized SOP/Policy copies *Retrieving, reconciling, and destroying superseded/obsolete SOPs/Policies *Prepare draft documents including formatting and circulate for approval. *Perform notification of QMS records and management of controlled document periodic reviews *Ensure proper electronic and hard-copy archiving and timely destruction of GMP documents. *Coordinate the inter-site transfer of Almac documents and provision of Quality-related documents to clients as required. *Support audits by obtaining GMP documents and information as required. *Manage Master Batch Records including updates to MBR and support Issuance of MBR based on master schedule *Provide administrative support to QA and QC staff as required. *Assist Quality personnel as needed. *Support site personnel with document management as needed. *Support Vendor Queries and updates to TROPOS as required. Qualifications: Required Experience / Education: *High School Diploma or Equivalency (required) *Minimum of six months' experience in administrative or document control functions required. *One year working experience any specific working environment, such as office setting or QA department. *Computer literacy including Microsoft Office products *Ability to create custom spreadsheets and databases using off-the-shelf applications preferred. Preferred Experience / Education: *College courses preferred *Relevant experience within a GLP/GMP environment. *Knowledge of the basic GMP requirements of the pharmaceutical industry What Almac Group can offer YOU! *Full medical, vision and dental benefits the 1st of the month after start date *20 days of PTO to start plus 12 holidays per year *Company paid long and short term disability along with life insurance *401k company match *Professional development programs/ continuous learning opportunities