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- Retrieving, reconciling, and destroying superseded/obsolete SOPs/Policies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.
Qualifications:
Required Experience / Education:
- High School Diploma or Equivalency
- 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 can Almac Group offer you?
- Medical, Vision & Dental benefits from the 1st of the month following start date
- 20 days PTO per year, accrued monthly following start date
- 12 holidays per year
- Company paid Long and Short-term disability along with Life Insurance
- 401k company contribution
- Professional development programs/ continuous learning opportunities
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Almac is an exceptional, award winning, drug development solutions provider at the forefront of the pharmaceutical industry. We are a privately owned organization that has organically grown over 50 years now employing 7,000 highly skilled personnel worldwide. Our US Headquarters is located at Souderton, PA with additional operations scattered around the US and Europe. ‘Partnering to Advance Human Health’ is more than just a tagline – it is our way of life.
Embracing diversity is at the heart of enhancing Almac Group’s unique culture and reflects our fundamental belief that all people deserve equality, inclusivity and the opportunity for advancement. We are committed to cultivating a welcoming, supportive, and inclusive environment for all. Together, we will build on the strength in our diversity and deliver exceptional solutions to advance human health globally.
RECRUITMENT AGENCIES PLEASE NOTE: Almac will only accept applications from agencies/business partners that have been invited to work on this role through our portal. Candidate Resumes/CV’s not submitted through our portal or directly to Hiring Managers will be considered unsolicited and no fee will be payable. Thank you for your cooperation.
Almac Group, Inc. is an Equal Opportunity Employer - Minorities/Women/Protected Veterans/Disabled - Proudly embracing diversity in all of its expressions.
Almac provides reasonable accommodations to people with disabilities who need assistance completing the application process. Please email us at [email protected] to request assistance.
