The QA Document Control Associate main responsibilities include creation and review of all labels, as well as maintaining and reviewing of batch record information, including medical records, testing results, and production records. Assists with all aspects of document control including issuing process records, label creation, and final disposition.
Essential Duties and Responsibilities:
Include but are not limited to the following, other duties may be applied;
Adhere to Standard Operating Procedures (SOPs) and maintaining Good Documentation Practices.
Create, issue, and review labels for manufacturing purposes.
Review and maintain batch record information, including outside testing results, patient medical history, and manufacturing processes.
Document control, including creation and revision of SOPs.
Maintain the training matrix/database as well as individual files.
Perform QA release of components and raw materials received as well as assist with final shipping review of released product to be distributed.
Conduct investigations, such as CAPAs, deviations, OOS, and non-conformances.
Qualifications:
Education and/or Experience
High School Diploma or AA degree
Knowledge of GMP and safety regulations
Experience with AATB accreditation and/or FDA 21CFR1271 regulations preferred, but not required.
Ability to communicate effectively, follow detailed directions, work independently, handle multiple tasks in a fast-paced environment.
Proficient in Microsoft Word, Excel and Outlook.
MasterControl Knowledge, a plus
Language Skills
Ability to write reports in the English language.
Ability to effectively present information and respond to questions from groups of supervisors and/or managers in the English language.
Mathematical Skills
Ability to calculate figures and amounts such as proportions and percentages.
Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.
Reasoning Ability
Ability to solve practical problems and handle a variety of concrete variables in situations where only limited standardization exists.
Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
Ability to define problems, collect data, establish facts, and draw valid conclusions.
Ability to interpret an extensive variety of technical instructions.
Strong analytical, numerical and reasoning abilities.
Well-developed interpersonal skills.
Participative work style.
Ability to establish credibility and be decisive.
Results oriented with a high level of initiative.
Certificates, Licenses, Registrations
CTBS Certifications are desirable
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. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- While performing the duties of this job, the Employee is regularly required to sit for long periods of time; walk; climbing stairs, stand; use hands to handle, or feel; reach with hands and arms; and talk or hear.
- The Employee must regularly lift and/or move up to 10 pounds and occasionally lift and/or move up to 40 pounds.
Work Environment and Environmental Conditions
The work environment characteristics described here are representative of those an Employee encounters while performing the essential functions of this job.
- Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- The noise level in the work environment is typically moderate.
- The environment is primarily a laboratory production environment with some warehouse duties.
- There is some limited exposure to physical risk and blood borne pathogens.
PPE Requirements
- Eye protection required when working in the operations area.
- Foot apparel must cover all portions of the foot.
- Other PPE such as gloves, sleeves, aprons and/or gowns may apply when inspecting equipment in the operations area.
Benefits:
- Medical, Dental, Vision Insurance.
- Company paid holidays.
- 2 weeks paid time off.
- 401(k) with Employer Match
Easily accessible to Tri-Rail and I-95.
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