The QA Administrative Assistant is primarily responsible for carrying out document control and project specific duties related to the general implementation and maintenance of Almac quality systems held in accordance with Almac Standard Operating Procedures (SOPs), current Good Manufacturing Practices (cGMP), and customer specifications.
Administrative tasks to support the operation of the QA department including:
- Process requests for additional pages to batch records for production.
- Coordinate the inter-site transfer of Almac documents and shipment of Quality-related documents to customer and regulatory representatives.
- Support customer audits by obtaining GMP documents and information.
- Provide administrative support to QA and QC staff including the following: Photocopying, Binding, Filing, Scanning/faxing.
- Processing CAPA addendum/effectiveness forms.
- Process Medication number list import and archive.
- Assist Archivist as needed.
- Administrative tasks to GMP documentation electronic systems:
- Maintain and update electronic document systems. PA and other Almac sites if needed.
- Create and maintain spreadsheets and databases of document reference numbers. Issue such numbers upon request.
- Create, reconcile and update excel spreadsheet for cGMP logbooks for use by Quality and Operations personnel.
- Issue Change Request Document (CRD) and Receiving (CRR) copies to appropriate documentation including SOPs, MBRs, etc and close document in MARS.
- Ensure proper electronic and hard copy archiving of GMP documents as listed previously and including but not limited to environmental monitoring records, analytical test results, and validation documents.
- Maintain control of Technical Agreements and Project Management Documents by: Issuing of controlled copies, circulating copies (signatory list), Updating MARS
- Maintain control of SOPs and Policies by: PA and other Almac sites if needed.
- Copying SOPs/Policies and issuing authorized SOP/Policy copies
- Retrieving, reconciling, and destroying superseded/obsolete SOPs/Policies
- Issuance authorized SOP/Policy copies to key trainers for training purposes
- Computer literacy including spreadsheets and databases.
- Ability to create custom spreadsheets and databases using off-the-shelf applications preferred.
- Assist Quality personnel as needed.
- Handling multiple responsibilities and job tasks (multi-tasking) as needed.
- Demonstrating attention to detail.
- Flexibility with work requirements, work environment and fast-paced/changing job needs.
Promoting teamwork by:
- Collaborating with co-workers.
- Attending staff meetings as required.
- Meeting individual company goals as established.
- Establishing rapport and maintaining positive communication with others, demonstrating respect and support, cooperating and flexibility with change.
- Adhering to company and department policies.
- Supervisory responsibilities of direct reports:
- This position does not supervise or have direct reports.
BASIC QUALIFICATIONS & POSITION REQUIREMENTS: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required.
- High School Diploma.
- Associate’s Degree or higher
Required Work Experience:
- 5 years experience with a High School Diploma.
- 2 years experience with an Associate’s Degree or higher.
- Work in a GMP environment.
- Electronic archiving systems
- Microsoft Office
- GMPs and Quality Systems
- Effective oral and written communications skills.
- Organizational skills.
- Strong customer service skills.
- Technical writing skills preferred.
- Ability to form good working relationships with team members and superiors.
- Meticulous, thorough, and consistent.
- Ability to work on own initiative.
- Ability to work to consistent high standards under pressure.
- Strong interpersonal skills preferred.
- Willingness to undertake additional responsibilities as required.
- Customer service/client relations
- Communication proficiency
- Attention to detail
WORK ENVIRONMENT & DRESS ATTIRE
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.
PHYSICAL DEMANDS The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Lifting: Weight Requirement up to 35 Lbs.
Number of Hours/Day Sedentary: 2-3 hours/day
Number of Hours/Day Remain stationary: Occasionally
Number of Hours/Day Bending/Reaching/Twisting: 2-3 hours/day
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
- Hybrid work available for applicable roles
- 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.