Reporting to the Manager, GMP Quality Assurance, the Specialist, GMP QA has experience in cGMP (Code of Federal Regulations 21CFR Parts 210, 211 and Part 11, EU GMP), as well as ICH Quality Guidance’s (Q9, Q10, Q11) and both USP and EP Pharmacopeia. The Specialist, GMP QA will have demonstrated ability to work in a laboratory setting and experience interfacing with customers on quality related matters.
The Specialist, GMP QA is responsible for assisting in the maintenance and improvement of the Quality System to meet compliance with GMP requirements. The Specialist, GMP QA will own one or more of the following Quality processes: Internal Audits, Vendor Qualification and Management, Change Control, Investigations and CAPA, Risk Management, or others as assigned. The role has shared responsibility for reviewing and approving data prior to it being submitted to clients. The role also has shared responsibility for the document control processes in MasterControl, including the review and approval process for documents.
- Reviews and approves data (Certificates of Analysis) prior to release to clients, including but not limited to QC Test data, method qualification and method validation data, clinical data entered into Data transfer forms.
- Owns and ensures processes used in QA are properly maintained, executed, measured and improved.
- Provides metrics for Quality Processes he/she owns for management review. Assists or performs the analysis for trends that indicate improvement opportunities.
- Assists in the performance of internal audits according to the internal audit schedule. Assures CAPAs to address findings are completed on time by CAPA owners.
- Assists with ad-hoc protocol, data, report, and in-lab internal audits to verify conformance to applicable SOPs, Test methods and regulatory requirements.
- Notifies management of quality/compliance trends and service failures.
- Facilitates changes to SOPs, policies, training materials, and other documents as needed.
- Supports and participates in the regulatory inspection/ customer audit process.
- Provides support for laboratory failure investigations.
- Provides support for deviation investigations.
- Provides support for Change Control, as needed.
- Provides Materials Review and release, as needed.
- Contributes to the supplier management process, as needed.
- Manages the records storage and archiving process for the GMP operation.
- Performs other duties as assigned.
- B.S. preferred in Biochemistry, Chemistry, or a related field
- 3-5 years’ experience
- Excellent written and oral communication skills.
- Cross-functional experience working across departments in an organization
- Strong organizational skills with ability to work independently and in a team, and multi-task
- Demonstrated Knowledge of ICH, FDA, and EMA regulatory and/or guidance documents as well as US and international pharmacopeia, as related to quality assurance activities.
- Demonstrated Communication and Collaboration skills to effectively provide training and coaching for quality processes, update Management on key issues and risks.
- Knowledge of the product to perform accurate quality assessments
- Attention to detail
- Analysis, critical-thinking and problem-solving skills to review systems, find flaws and pose solutions
- Experience with Master Control a plus.
- ASQ Auditor Certification a plus.
Prolytix, formerly Haematologic Technologies (HT), is a leading provider of analytical and bioanalytical services to support the research, development, and commercialization of large molecule biotherapeutics and reagents for coagulation research. Prolytix builds on 30+ years of expertise to identify and solve the most complex large molecule challenges. Prolytix’s expertise in protein biochemistry supports biotherapeutics from discovery through commercial release, with biopharma services all performed in fully compliant, FDA-inspected GMP facilities. The company also provides expertise in plasma proteins, hemostasis, and blood coagulation and is a leading global supplier of coagulation research reagents (plasma proteins and antibodies), custom formulated IVD/POC device reagents, as well as customized blood collection tubes to support clinical trials. Visit us at goprolytix.com.